Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent Exacerbations  (RESOLUTE)

Recruitment Status:
Recruiting

Sponsor:
AstraZeneca

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT04053634

Verification:
Verified 01 November 2022   by AstraZeneca

History of Changes:
ClinicalTrials.gov

Purpose

Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL).
Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count.
The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of
56 weeks, at which point all patients will complete the study. The primary
endpoint will be analyzed at Week 56.

Official Title:A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
Study Type:Interventional
Overall Recruitment Status:Recruiting
Study Start Date:26 August 2019
Study Start Date Type:Actual
Primary Completion Date:27 June 2025
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
ConditionInterventionPhase
Chronic Obstructive Pulmonary Disease
Biological/Vaccine: Benralizumab
Biological/Vaccine: Placebo
Phase 3
Ages Eligible for Study: 40 Years  to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
1 Provision of informed consent

2 Age 40 to 85 years

3 Male and/or female.

4 Current or former smoker with a tobacco history of ≥10 pack-years.

5 History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value.

6 Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.

(a) Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.

(b) Hospitalization is defined as an inpatient admission ≥24 hours

(c) Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.

(d) At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment.

7 Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for ≥3 months immediately prior to enrollment.

(a) Treatment with at least double inhaled therapy containing ICS (e.g. ICS/LABA or ICS/LAMA) for the remaining of 52 weeks prior to enrolment. Use of LABA/LAMA is allowed if ICS cannot be tolerated.

(b) ICS in a dose approved for COPD or equivalent to ≥250 mcg of fluticasone propionate daily.

(c) Total cumulative duration of not being on double or triple background therapy must not exceed 2 months.

(d) Stable therapy/doses for the last 3 months prior to randomization.

8 Blood eosinophil count ≥300/μL at screening and documented historical eosinophil count of ≥150/μL within 52 weeks of enrollment (or repeated testing during run-in).

9 CAT total score ≥15 at Visit 1.

10 Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.

11 Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP.
Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).



Exclusion Criteria:
1 Clinically important pulmonary disease other than COPD

2 Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap according to
GINA/GOLD. Childhood history of asthma is allowed and defined as asthma diagnosed
and resolved before the age of 18.

3 Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.

4 Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

5 Any unstable disorder that could affect patient safety, study findings or the patient’s ability to complete the study.

6 Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient’s ability to complete the study.

7 Cor pulmonale and/or right ventricular failure.

8 Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen.

9 Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP for Sleep Apnea Syndrome is allowed.

10 Known immunodeficiency disorder, including positive HIV-1/2 testing.

11 Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable.

12 ALT or AST ≥3 times the upper limit of normal, confirmed by repeated testing during the run-in period.

13 Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy.

14 Alcohol or drug abuse within the past year, which may compromise the study data.

15 Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms.

16 Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care.

17 Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed).

18 History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable).

19 Scheduled major surgical procedure during the study. Minor elective procedures are allowed.

20 History of anaphylaxis to any biologic therapy or vaccine.

21 Receipt of blood products or immunoglobulins within 30 days prior to randomization.

22 Receipt of marketed or investigational biologic product within 4
months or 5 half-lives prior to randomization, whichever is longer. Exception: Patients on stable therapy for 3 months before randomization who intend to stay on treatment throughout the study with
marketed biologic products that are not likely to interfere with the safety
assessment and/or efficacy of benralizumab, for example, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic diseases, can participate in the study.

23 Receipt of live attenuated vaccines 30 days prior to randomization.

24 Chronic use of immunosuppressive medication or expected need for chronic use during the study.

25 Chronic use of antibiotics if duration of treatment is <9 months prior to randomization. Chronic macrolide or other antibiotic therapy is allowed provided the patient has been on stable dose/regimen for ≥9 months prior to randomization and has had ≥2 COPD exacerbations while on stable therapy.

26 Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment.

27 Receipt of benralizumab within 12 months prior to enrollment.

28 Known history of allergy or reaction to any component of the IP formulation.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    [email protected]  

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Gerard  Criner , MD   Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140

Locations

CountryLocationFacilityContactStatus
TRResearch Site Adana, TR, 01330Recruiting
TRResearch Site Ankara, TR, 06Withdrawn
TRResearch Site Antalya, TR, 07070Withdrawn
TRResearch Site Istanbul, TR, 34098Recruiting
TRResearch Site İstanbul, TR, 34844Recruiting
TRResearch Site Izmir, TR, 35110Recruiting
TRResearch Site Kocaeli, TR, 41380Recruiting
TRResearch Site Mersin, TR, 33343Recruiting
US , PAResearch Site Doylestown, PA, US, 18901Withdrawn
US , PAResearch Site Du Bois, PA, US, 15801Recruiting
US , PAResearch Site Philadelphia, PA, US, 19140Recruiting
US , PAResearch Site Pittsburgh, PA, US, 15213Recruiting
US , PAResearch Site Smithfield, PA, US, 15478Recruiting
CA , QCResearch Site Montreal, QC, CA, H4A 3J1Recruiting
CA , QCResearch Site Quebec, QC, CA, G2J 0C4Recruiting
CA , QCResearch Site Quebec, QC, CA, G1W 4R4Terminated
CA , QCResearch Site Quebec, QC, CA, G1V 4W2Recruiting
CA , ONResearch Site Ajax, ON, CA, L1S 2J5Recruiting
CA , ONResearch Site Barrie, ON, CA, L4M 6M2Terminated
CA , ONResearch Site Sarnia, ON, CA, N7T 4X3Terminated
CA , ONResearch Site Stouffville, ON, CA, L4A 1H2Recruiting
CA , ONResearch Site Toronto, ON, CA, M5T 3A9Recruiting
CA , ONResearch Site Toronto, ON, CA, M9V 4B4Suspended
ARResearch Site Buenos Aires, AR, S2000PBJRecruiting
ARResearch Site CABA, AR, C1012AARRecruiting
ARResearch Site Ciudad Autónoma de Buenos Aire, AR, C1440BRRSuspended
ARResearch Site Ciudad de Buenos Aires, AR, 1425Recruiting
ARResearch Site Córdoba, AR, X5003DCERecruiting
ARResearch Site Florencio Varela, AR, 1888Recruiting
ARResearch Site Florida, AR, B1602DQDRecruiting
ARResearch Site Mar del Plata, AR, B7600GWVRecruiting
ARResearch Site Mendoza, AR, M5500GIPRecruiting
ARResearch Site San Fernando, AR, B1646EBJRecruiting
ARResearch Site Tucumán, AR, 4000Recruiting
GBResearch Site Barnsley, GB, S75 3DLRecruiting
GBResearch Site Birmingham, GB, B9 5SSRecruiting
GBResearch Site Blackpool, GB, FY2 0JHRecruiting
GBResearch Site Bradford, GB, BD9 6RJRecruiting
GBResearch Site Chertsey, GB, KT16 0PZActive, not recruiting
GBResearch Site Cottingham, GB, HU16 5JQRecruiting
GBResearch Site Larbert, GB, FK5 4WRWithdrawn
GBResearch Site Leicester, GB, LE3 9QPRecruiting
GBResearch Site Manchester, GB, M13 9NQRecruiting
GBResearch Site Oxford, GB, OX3 7LERecruiting
GBResearch Site Perth, GB, PH1 1NXRecruiting
GBResearch Site Southampton, GB, SO166YDRecruiting
GBResearch Site Stockton-on-Tees, GB, TS17 6EWRecruiting
GBResearch Site Wishaw, GB, ML2 0DPRecruiting
CA , NSResearch Site Bridgewater, NS, CA, B4V 3N2Suspended
CA , NSResearch Site Lower Sackville, NS, CA, B4C 2S4Withdrawn
PHResearch Site Cavite City, PH, 4114Suspended
PHResearch Site Iloilo City, PH, 5000Recruiting
PHResearch Site Iloilo City, PH, 5000Recruiting
PHResearch Site Los Baños, PH, 4030Not yet recruiting
PHResearch Site Marilao, PH, 3019Not yet recruiting
PHResearch Site Quezon City, PH, 1100Recruiting
CZResearch Site Brandys nad Labem, CZ, 250 01Recruiting
CZResearch Site Jindrichuv Hradec, CZ, 377 01Recruiting
CZResearch Site Ostrava, CZ, 708 68Recruiting
CZResearch Site Rokycany, CZ, 337 22Recruiting
CZResearch Site Teplice, CZ, 415 01Recruiting
ESResearch Site Barcelona, ES, 08003Withdrawn
ESResearch Site Hospitalet de Llobregat(Barcel, ES, 08907Recruiting
ESResearch Site Laredo, ES, 39770Completed
ESResearch Site Madrid, ES, 28007Recruiting
ESResearch Site Madrid, ES, 28046Recruiting
ESResearch Site Madrid, ES, 28850Not yet recruiting
ESResearch Site Malaga, ES, 29010Recruiting
ESResearch Site Santander, ES, 39008Recruiting
US , OHResearch Site Cleveland, OH, US, 44106Recruiting
US , OHResearch Site Cleveland, OH, US, 44106Not yet recruiting
US , OHResearch Site Columbus, OH, US, 43215Recruiting
US , ORResearch Site Happy Valley, OR, US, 97086Withdrawn
US , ORResearch Site Medford, OR, US, 97504Completed
US , SDResearch Site Rapid City, SD, US, 57702Recruiting
US , SCResearch Site Charleston, SC, US, 29407Suspended
US , SCResearch Site Greenville, SC, US, 29615Withdrawn
US , SCResearch Site Mount Pleasant, SC, US, 29464Terminated
US , SCResearch Site North Charleston, SC, US, 29406Recruiting
US , SCResearch Site Rock Hill, SC, US, 29732Recruiting
US , SCResearch Site Spartanburg, SC, US, 29303Withdrawn
US , CAResearch Site Huntington Beach, CA, US, 92647Recruiting
US , CAResearch Site Long Beach, CA, US, 90806Withdrawn
US , CAResearch Site Los Angeles, CA, US, 90048Recruiting
US , CAResearch Site Los Angeles, CA, US, 90033Not yet recruiting
US , CAResearch Site Newport Beach, CA, US, 92663Recruiting
US , CAResearch Site Northridge, CA, US, 91324Recruiting
US , CAResearch Site Northridge, CA, US, 91324Recruiting
US , CAResearch Site Palm Springs, CA, US, 92262Recruiting
US , CAResearch Site Palm Springs, CA, US, 92262Completed
US , CAResearch Site San Diego, CA, US, 92120Withdrawn
US , CAResearch Site San Diego, CA, US, 92103Recruiting
US , CAResearch Site Westminster, CA, US, 92683Recruiting
CLResearch Site Curico, CL, 3341643Recruiting
CLResearch Site Quillota, CL, 2260000Recruiting
CLResearch Site Santiago, CL, 7500698Recruiting
CLResearch Site Santiago, CL, 7500692Recruiting
CLResearch Site Santiago, CL, 7500571Terminated
CLResearch Site Santiago, CL, 8380453Not yet recruiting
CLResearch Site Talca, CL, 3465584Recruiting
CLResearch Site Viña del Mar, CL, 2520997Withdrawn
US , FLResearch Site Brandon, FL, US, 33511Withdrawn
US , FLResearch Site Clearwater, FL, US, 33765Recruiting
US , FLResearch Site Daytona Beach, FL, US, 32117Terminated
US , FLResearch Site Edgewater, FL, US, 32132Terminated
US , FLResearch Site Jacksonville, FL, US, 32209Recruiting
US , FLResearch Site Jacksonville, FL, US, 32204Recruiting
US , FLResearch Site Kissimmee, FL, US, 34741Recruiting
US , FLResearch Site Kissimmee, FL, US, 34746Recruiting
US , FLResearch Site Leesburg, FL, US, 34748Recruiting
US , FLResearch Site Orlando, FL, US, 32819Recruiting
US , FLResearch Site Pensacola, FL, US, 32503Recruiting
US , FLResearch Site Saint Petersburg, FL, US, 33707Recruiting
US , FLResearch Site Tampa, FL, US, 33607Recruiting
US , FLResearch Site Winter Park, FL, US, 32789Recruiting
HUResearch Site Balassagyarmat, HU, 2660Recruiting
HUResearch Site Budapest, HU, 1033Recruiting
HUResearch Site Edelény, HU, 3780Recruiting
HUResearch Site Encs, HU, 3860Recruiting
HUResearch Site Gödöllő, HU, 2100Recruiting
HUResearch Site Hajdúnánás, HU, 4080Recruiting
HUResearch Site Komárom, HU, 2900Recruiting
HUResearch Site Pécs, HU, 7635Recruiting
HUResearch Site Siófok, HU, 8600Terminated
HUResearch Site Százhalombatta, HU, 2440Recruiting
HUResearch Site Szeged, HU, 6722Terminated
HUResearch Site Törökbálint, HU, 2045Recruiting
KRResearch Site Daegu, KR, 42415Recruiting
KRResearch Site Jeonju-si, KR, 54907Recruiting
KRResearch Site Seoul, KR, 06591Recruiting
KRResearch Site Seoul, KR, 03312Recruiting
KRResearch Site Seoul, KR, 05030Recruiting
KRResearch Site Seoul, KR, 04401Terminated
KRResearch Site Wonju-si, KR, 26426Recruiting
ATResearch Site Bludenz, AT, 6700Recruiting
ATResearch Site Feldbach, AT, A-8330Recruiting
ATResearch Site Grieskirchen, AT, 4710Recruiting
ATResearch Site Linz, AT, 4020Recruiting
ATResearch Site Thalheim, AT, 4600Completed
BRResearch Site Blumenau, BR, 89030-101Not yet recruiting
BRResearch Site Botucatu, BR, 18.618-686Recruiting
BRResearch Site Florianópolis, BR, 88036-800Recruiting
BRResearch Site Maringa, BR, 87015-000Recruiting
BRResearch Site Porto Alegre, BR, 90610-000Recruiting
BRResearch Site Porto Alegre, BR, 91350-200Recruiting
BRResearch Site Porto Alegre, BR, 9002-060Recruiting
BRResearch Site Porto Alegre, BR, 90020-090Recruiting
BRResearch Site Porto Alegre, BR, 90430-001Suspended
BRResearch Site Santo Andre, BR, 09080-110Recruiting
BRResearch Site Sao Bernardo do Campo, BR, 09750-420Recruiting
BRResearch Site Sao Paulo, BR, 05403-000Recruiting
BRResearch Site Sorocaba, BR, 18040-425Recruiting
BRResearch Site Uberlandia, BR, 38411-186Withdrawn
CA , SKResearch Site Saskatoon, SK, CA, S7N 0W8Recruiting
COResearch Site Barranquilla, CO, 80007Recruiting
COResearch Site Cali, CO, 76001000Recruiting
COResearch Site Floridablanca, CO, 681004Recruiting
COResearch Site Medellin, CO, 5001000Recruiting
COResearch Site Pereira, CO, 660003Recruiting
COResearch Site Rionegro, CO, 54048Withdrawn
COResearch Site Zipaquira, CO, 200251Recruiting
SEResearch Site Göteborg, SE, 413 45Recruiting
SEResearch Site Göteborg, SE, 413 46Recruiting
SEResearch Site Helsingborg, SE, 25220Suspended
SEResearch Site LUND, SE, 222 22Recruiting
SEResearch Site Malmö, SE, 205 02Recruiting
SEResearch Site Stockholm, SE, 114 46Recruiting
JPResearch Site Chuo-ku, JP, 104-0031Recruiting
JPResearch Site Chuo-ku, JP, 104-0031Terminated
JPResearch Site Chuo-ku, JP, 103-0022Recruiting
JPResearch Site Fukuoka-shi, JP, 814-0180Recruiting
JPResearch Site Himeji-shi, JP, 672-8064Terminated
JPResearch Site Hitachinaka-shi, JP, 312-0057Recruiting
JPResearch Site Joyo-shi, JP, 610-0113Recruiting
JPResearch Site Kasuga-shi, JP, 816-0813Withdrawn
JPResearch Site Kawachinagano-shi, JP, 586-8521Recruiting
JPResearch Site Kishiwada-shi, JP, 596-8501Recruiting
JPResearch Site Kobe-shi, JP, 650-0047Recruiting
JPResearch Site Koto-ku, JP, 136-0075Recruiting
JPResearch Site Kure-shi, JP, 737-0023Recruiting
JPResearch Site Matsusaka-shi, JP, 515-8544Recruiting
JPResearch Site Meguro-ku, JP, 152-8902Withdrawn
JPResearch Site Mizunami-shi, JP, 509-6134Active, not recruiting
JPResearch Site Nagaoka-shi, JP, 940-2085Recruiting
JPResearch Site Nagoya-shi, JP, 457-8511Recruiting
JPResearch Site Nishinomiya-shi, JP, 663-8501Recruiting
JPResearch Site Okayama-shi, JP, 700-8558Terminated
JPResearch Site Osaka-shi, JP, 531-0073Recruiting
JPResearch Site Sagamihara-shi, JP, 252-0315Recruiting
JPResearch Site Sakaide-shi, JP, 762-8550Recruiting
JPResearch Site Sakai-shi, JP, 591-8555Recruiting
JPResearch Site Seto-shi, JP, 489-8642Recruiting
JPResearch Site Shinagawa-ku, JP, 142-8666Recruiting
JPResearch Site Shinagawa-ku, JP, 140-8522Recruiting
JPResearch Site Toshima-ku, JP, 171-0014Recruiting
JPResearch Site Toshima-ku, JP, 170-0003Recruiting
JPResearch Site Toshima-ku, JP, 170-0002Not yet recruiting
JPResearch Site Toyonaka-shi, JP, 560-8552Recruiting
JPResearch Site Ueda-shi, JP, 386-8610Recruiting
JPResearch Site Yanagawa-shi, JP, 832-0059Recruiting
JPResearch Site Yokohama-shi, JP, 223-0059Recruiting
DEResearch Site Aachen, DE, 52074Withdrawn
DEResearch Site Bamberg, DE, 96049Recruiting
DEResearch Site Berlin, DE, 10717Recruiting
DEResearch Site Berlin, DE, 13187Recruiting
DEResearch Site Berlin, DE, 12157Recruiting
DEResearch Site Darmstadt, DE, 64283Recruiting
DEResearch Site Hamburg, DE, 20354Recruiting
DEResearch Site Hannover, DE, D-30173Recruiting
DEResearch Site Koblenz, DE, 56068Recruiting
DEResearch Site Köln, DE, 51069Recruiting
DEResearch Site Leipzig, DE, 04357Recruiting
DEResearch Site Leipzig, DE, 04207Recruiting
DEResearch Site Leipzig, DE, 04103Terminated
DEResearch Site Marburg, DE, 35037Recruiting
DEResearch Site Marburg, DE, 35037Withdrawn
DEResearch Site Neu-Isenburg, DE, 63263Recruiting
DEResearch Site Peine, DE, 31224Recruiting
DEResearch Site Potsdam, DE, 14467Recruiting
DEResearch Site Rheine, DE, 48431Completed
DEResearch Site Warendorf, DE, 48231Terminated
US , ILResearch Site Chicago, IL, US, 60611Recruiting
US , ILResearch Site Evanston, IL, US, 60201Recruiting
US , ILResearch Site O Fallon, IL, US, 62269Terminated
US , ILResearch Site Peoria, IL, US, 61636Recruiting
US , VAResearch Site Abingdon, VA, US, 24210Recruiting
US , VAResearch Site Williamsburg, VA, US, 23188Recruiting
US , NCResearch Site Burlington, NC, US, 27215Completed
US , NCResearch Site Chapel Hill, NC, US, 27517Recruiting
US , NCResearch Site Charlotte, NC, US, 28277Recruiting
US , NCResearch Site Charlotte, NC, US, 28287Suspended
US , NCResearch Site Elizabeth City, NC, US, 27909Recruiting
US , NCResearch Site Gastonia, NC, US, 28054Recruiting
US , NCResearch Site Mooresville, NC, US, 28117Terminated
US , NCResearch Site New Bern, NC, US, 28562Recruiting
US , NCResearch Site Wilmington, NC, US, 28401Recruiting
US , NCResearch Site Winston Salem, NC, US, 27103Suspended
US , TXResearch Site Amarillo, TX, US, 79124Recruiting
US , TXResearch Site Cypress, TX, US, 77429Recruiting
US , TXResearch Site Dallas, TX, US, 75390Not yet recruiting
US , TXResearch Site Fort Worth, TX, US, 76104Recruiting
US , TXResearch Site Houston, TX, US, 77079Completed
US , TXResearch Site Kerrville, TX, US, 78028Recruiting
US , TXResearch Site San Antonio, TX, US, 78258Recruiting
US , TXResearch Site Spring, TX, US, 77380Recruiting
US , TXResearch Site Tomball, TX, US, 77375Terminated
US , TXResearch Site Weatherford, TX, US, 76086Recruiting
US , MIResearch Site Farmington Hills, MI, US, 48336Recruiting
US , WAResearch Site Everett, WA, US, 98208Recruiting
US , WAResearch Site Spokane, WA, US, 99204Recruiting
PLResearch Site Białystok, PL, 15-044Recruiting
PLResearch Site Katowice, PL, 40-648Recruiting
PLResearch Site Krakow, PL, 30-510Not yet recruiting
PLResearch Site Łódź, PL, 90-153Recruiting
PLResearch Site Ostrowiec Świętokrzyski, PL, 27-400Not yet recruiting
PLResearch Site Poznań, PL, 61-578Recruiting
PLResearch Site Poznań, PL, 60-693Recruiting
PLResearch Site Proszowice, PL, 32-100Terminated
PLResearch Site Rzeszów, PL, 35-051Recruiting
PLResearch Site Skierniewice, PL, 96-100Not yet recruiting
PLResearch Site Warszawa, PL, 02-793Recruiting
PLResearch Site Wieluń, PL, 98-300Terminated
DKResearch Site Ålborg, DK, 9000Recruiting
DKResearch Site Hvidovre, DK, 2650Recruiting
DKResearch Site København NV, DK, 2400Recruiting
DKResearch Site Odense C, DK, 5000Recruiting
DKResearch Site Roskilde, DK, 4000Recruiting
DKResearch Site Vejle, DK, 7100Recruiting
ITResearch Site Catanzaro, IT, 88100Suspended
ITResearch Site Cona, IT, 44124Recruiting
ITResearch Site Genova, IT, 16132Recruiting
ITResearch Site Milano, IT, 20157Recruiting
ITResearch Site Milano, IT, 20142Recruiting
ITResearch Site NAPOLI, IT, 80131Recruiting
ITResearch Site Reggio Emilia, IT, 42123Recruiting
ITResearch Site Roma, IT, 00168Recruiting
US , NYResearch Site Bronx, NY, US, 10461Recruiting
US , NYResearch Site Bronx, NY, US, 10455Recruiting
US , NYResearch Site Buffalo, NY, US, 14215Recruiting
US , NYResearch Site New Windsor, NY, US, 12553Recruiting
US , NYResearch Site Potsdam, NY, US, 13676Recruiting
US , INResearch Site Michigan City, IN, US, 46360Completed
US , INResearch Site Valparaiso, IN, US, 46383Withdrawn
US , MDResearch Site Baltimore, MD, US, 21224Recruiting
US , MDResearch Site Columbia, MD, US, 21044Recruiting
CA , BCResearch Site Kelowna, BC, CA, V1Y 3H5Not yet recruiting
US , MOResearch Site Chesterfield, MO, US, 63017Suspended
US , MAResearch Site Boston, MA, US, 02215Recruiting
US , MAResearch Site North Dartmouth, MA, US, 02747Recruiting
US , NDResearch Site Fargo, ND, US, 58104Withdrawn
US , GAResearch Site Columbus, GA, US, 31904Recruiting
US , GAResearch Site Decatur, GA, US, 30033Recruiting
US , GAResearch Site Lawrenceville, GA, US, 30046Recruiting
US , GAResearch Site Rincon, GA, US, 31326Recruiting
US , GAResearch Site Woodstock, GA, US, 30189Withdrawn
US , CTResearch Site Stamford, CT, US, 06902Completed
US , TNResearch Site Chattanooga, TN, US, 37404Recruiting
US , TNResearch Site Franklin, TN, US, 37067Recruiting
US , TNResearch Site Hendersonville, TN, US, 37075Recruiting
AUResearch Site Caringbah, AU, 2229Recruiting
AUResearch Site Melbourne, AU, 3004Recruiting
AUResearch Site South Brisbane, AU, 4101Recruiting
AUResearch Site Southport, AU, 4215Recruiting
AUResearch Site Spearwood, AU, 6163Recruiting
NLResearch Site AMERSFOORT, NL, 3813 TZRecruiting
NLResearch Site BREDA, NL, 4818 CKRecruiting
NLResearch Site Den Bosch, NL, 5223 GZRecruiting
NLResearch Site Den Haag, NL, 2512 VAWithdrawn
NLResearch Site LEEUWARDEN, NL, 8934 ADRecruiting
NZResearch Site Auckland, NZ, 1051Recruiting
NZResearch Site Christchurch, NZ, 8013Recruiting
NZResearch Site Christchurch, NZ, 8024Recruiting
NZResearch Site Dunedin, NZ, 9016Recruiting
NZResearch Site Hamilton, NZ, 3204Recruiting
US , KYResearch Site Georgetown, KY, US, 40324Completed
US , KYResearch Site Lexington, KY, US, 40502Not yet recruiting
US , AZResearch Site Surprise, AZ, US, 85374Recruiting
US , AZResearch Site Tucson, AZ, US, 85724Recruiting
BEResearch Site Edegem, BE, 2650Recruiting
BEResearch Site Erpent, BE, 5101Recruiting
US , OKResearch Site Oklahoma City, OK, US, 73106Completed
US , IAResearch Site Council Bluffs, IA, US, 51503Withdrawn
US , IAResearch Site Iowa City, IA, US, 52242Recruiting
US , NEResearch Site Lincoln, NE, US, 68510Recruiting
US , NEResearch Site Omaha, NE, US, 68124Recruiting
US , KSResearch Site Kansas City, KS, US, 66160Recruiting
GRResearch Site Athens, GR, 11527Recruiting
GRResearch Site Athens, GR, 10676Recruiting
GRResearch Site ATHENS, GR, 11527Withdrawn
GRResearch Site ATHENS, GR, 12462Withdrawn
GRResearch Site HERAKLION, GR, 71110Withdrawn
GRResearch Site IOANNINA, GR, 45500Recruiting
GRResearch Site THESSALONIKI, GR, 57010Recruiting
GRResearch Site THESSALONIKI, GR, 56429Recruiting
US , DEResearch Site Newark, DE, US, 19713Recruiting
US , WVResearch Site Morgantown, WV, US, 26505Recruiting
US , UTResearch Site Salt Lake City, UT, US, 84102Recruiting
MXResearch Site Guadalajara, MX, 44100Recruiting
MXResearch Site Guadalajara, MX, 44130Recruiting
MXResearch Site Guadalajara, MX, 44200Not yet recruiting
MXResearch Site Mérida, MX, 97070Not yet recruiting
MXResearch Site Mexico, MX, 07760Withdrawn
MXResearch Site Mexico, MX, 06726Withdrawn
MXResearch Site Monterrey, MX, 64460Not yet recruiting
MXResearch Site Veracruz, MX, 91910Recruiting
US , NJResearch Site Brick, NJ, US, 08724Withdrawn
US , NJResearch Site Toms River, NJ, US, 08755Recruiting
US , ALResearch Site Montgomery, AL, US, 36116Withdrawn
US , WIResearch Site Cudahy, WI, US, 53110Recruiting
US , ARResearch Site Little Rock, AR, US, 72209Completed
CA , NFResearch Site St. John's, NF, CA, A1A 3R5Recruiting
CA , ABResearch Site Calgary, AB, CA, T3B 0M3Recruiting
CA , ABResearch Site Edmonton, AB, CA, T5J 3S9Withdrawn
CAResearch Site Chicoutimi, CA, G7H 5H6Recruiting
CNResearch Site Baotou, CN, 14010Recruiting
CNResearch Site Beijing, CN, 100034Recruiting
CNResearch Site Beijing, CN, 102218Not yet recruiting
CNResearch Site changsha, CN, 410015Recruiting
CNResearch Site changsha, CN, 410005Recruiting
CNResearch Site Changsha, CN, 430033Recruiting
CNResearch Site Chengdu, CN, 610041Recruiting
CNResearch Site Chengdu, CN, 610072Withdrawn
CNResearch Site Chongqing, CN, 402260Not yet recruiting
CNResearch Site Ganzhou, CN, 341000Not yet recruiting
CNResearch Site Guangzhou, CN, 510180Recruiting
CNResearch Site Guangzhou, CN, 510120Recruiting
CNResearch Site Guangzhou, CN, 510630Recruiting
CNResearch Site GUANGZHOU, CN, 510180Recruiting
CNResearch Site Guiyang, CN, 550002Recruiting
CNResearch Site Haikou, CN, 570311Recruiting
CNResearch Site hangzhou, CN, 310006Withdrawn
CNResearch Site Hebei, CN, Not yet recruiting
CNResearch Site Hefei, CN, 230001Recruiting
CNResearch Site Hohhot, CN, 010017Recruiting
CNResearch Site Hohhot, CN, 10050Not yet recruiting
CNResearch Site Kunming, CN, 650032Withdrawn
CNResearch Site Linhai, CN, 317000Recruiting
CNResearch Site Nanchang, CN, 330006Recruiting
CNResearch Site Nanchang, CN, 330006Recruiting
CNResearch Site Nanchang, CN, 330006Recruiting
CNResearch Site nanjing, CN, 210011Withdrawn
CNResearch Site Nanjing, CN, 210012Not yet recruiting
CNResearch Site Shanghai, CN, 200433Recruiting
CNResearch Site Shanghai, CN, 200002Recruiting
CNResearch Site Shanghai, CN, 200092Recruiting
CNResearch Site Shanghai, CN, 200240Withdrawn
CNResearch Site Shanghai, CN, 200032Recruiting
CNResearch Site Shenyang, CN, 110015Recruiting
CNResearch Site Shenyang, CN, 100003Withdrawn
CNResearch Site Shenzhen, CN, 518020Recruiting
CNResearch Site Shenzhen, CN, 518039Withdrawn
CNResearch Site Shijiazhuang, CN, 50051Withdrawn
CNResearch Site Suzhou, CN, 215000Recruiting
CNResearch Site Urumqi, CN, Recruiting
CNResearch Site wenzhou, CN, 325027Recruiting
CNResearch Site Wuhan, CN, Recruiting
CNResearch Site Wuhan, CN, 430030Recruiting
CNResearch Site Xi'an, CN, 710061Recruiting
CNResearch Site Yangzhou, CN, 225000Withdrawn
CNResearch Site Yanji, CN, 133000Withdrawn
CNResearch Site Yinchuan, CN, 750001Recruiting
CNResearch Site Yinchuan, CN, 750004Withdrawn
CNResearch Site Yiyang, CN, 413000Recruiting
CNResearch Site Zhanjiang, CN, 524001Recruiting
CNResearch Site Zhengzhou, CN, 450003Not yet recruiting
US , Puerto RicoResearch Site Caguas, Puerto Rico, US, 00727Not yet recruiting

 File nameDescription
This is a poster on the Resolute study.This is a poster on the Resolute study.
.

Purpose

Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL).
Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count.
The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of
56 weeks, at which point all patients will complete the study. The primary
endpoint will be analyzed at Week 56.

Official Title:A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
Study Type:Interventional
Overall Recruitment Status:Recruiting
Study Start Date:26 August 2019
Study Start Date Type:Actual
Primary Completion Date:27 June 2025
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
ConditionInterventionPhase
Chronic Obstructive Pulmonary Disease
Biological/Vaccine: Benralizumab
Biological/Vaccine: Placebo
Phase 3
Ages Eligible for Study: 40 Years  to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
1 Provision of informed consent

2 Age 40 to 85 years

3 Male and/or female.

4 Current or former smoker with a tobacco history of ≥10 pack-years.

5 History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value.

6 Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.

(a) Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.

(b) Hospitalization is defined as an inpatient admission ≥24 hours

(c) Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.

(d) At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment.

7 Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for ≥3 months immediately prior to enrollment.

(a) Treatment with at least double inhaled therapy containing ICS (e.g. ICS/LABA or ICS/LAMA) for the remaining of 52 weeks prior to enrolment. Use of LABA/LAMA is allowed if ICS cannot be tolerated.

(b) ICS in a dose approved for COPD or equivalent to ≥250 mcg of fluticasone propionate daily.

(c) Total cumulative duration of not being on double or triple background therapy must not exceed 2 months.

(d) Stable therapy/doses for the last 3 months prior to randomization.

8 Blood eosinophil count ≥300/μL at screening and documented historical eosinophil count of ≥150/μL within 52 weeks of enrollment (or repeated testing during run-in).

9 CAT total score ≥15 at Visit 1.

10 Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.

11 Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP.
Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).



Exclusion Criteria:
1 Clinically important pulmonary disease other than COPD

2 Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap according to
GINA/GOLD. Childhood history of asthma is allowed and defined as asthma diagnosed
and resolved before the age of 18.

3 Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.

4 Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

5 Any unstable disorder that could affect patient safety, study findings or the patient’s ability to complete the study.

6 Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient’s ability to complete the study.

7 Cor pulmonale and/or right ventricular failure.

8 Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen.

9 Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP for Sleep Apnea Syndrome is allowed.

10 Known immunodeficiency disorder, including positive HIV-1/2 testing.

11 Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable.

12 ALT or AST ≥3 times the upper limit of normal, confirmed by repeated testing during the run-in period.

13 Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy.

14 Alcohol or drug abuse within the past year, which may compromise the study data.

15 Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms.

16 Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care.

17 Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed).

18 History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable).

19 Scheduled major surgical procedure during the study. Minor elective procedures are allowed.

20 History of anaphylaxis to any biologic therapy or vaccine.

21 Receipt of blood products or immunoglobulins within 30 days prior to randomization.

22 Receipt of marketed or investigational biologic product within 4
months or 5 half-lives prior to randomization, whichever is longer. Exception: Patients on stable therapy for 3 months before randomization who intend to stay on treatment throughout the study with
marketed biologic products that are not likely to interfere with the safety
assessment and/or efficacy of benralizumab, for example, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic diseases, can participate in the study.

23 Receipt of live attenuated vaccines 30 days prior to randomization.

24 Chronic use of immunosuppressive medication or expected need for chronic use during the study.

25 Chronic use of antibiotics if duration of treatment is <9 months prior to randomization. Chronic macrolide or other antibiotic therapy is allowed provided the patient has been on stable dose/regimen for ≥9 months prior to randomization and has had ≥2 COPD exacerbations while on stable therapy.

26 Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment.

27 Receipt of benralizumab within 12 months prior to enrollment.

28 Known history of allergy or reaction to any component of the IP formulation.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    [email protected]  

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Gerard  Criner , MD   Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140

Locations

CountryLocationFacilityContactStatus
TRResearch Site Adana, TR, 01330Recruiting
TRResearch Site Ankara, TR, 06Withdrawn
TRResearch Site Antalya, TR, 07070Withdrawn
TRResearch Site Istanbul, TR, 34098Recruiting
TRResearch Site İstanbul, TR, 34844Recruiting
TRResearch Site Izmir, TR, 35110Recruiting
TRResearch Site Kocaeli, TR, 41380Recruiting
TRResearch Site Mersin, TR, 33343Recruiting
US , PAResearch Site Doylestown, PA, US, 18901Withdrawn
US , PAResearch Site Du Bois, PA, US, 15801Recruiting
US , PAResearch Site Philadelphia, PA, US, 19140Recruiting
US , PAResearch Site Pittsburgh, PA, US, 15213Recruiting
US , PAResearch Site Smithfield, PA, US, 15478Recruiting
CA , QCResearch Site Montreal, QC, CA, H4A 3J1Recruiting
CA , QCResearch Site Quebec, QC, CA, G2J 0C4Recruiting
CA , QCResearch Site Quebec, QC, CA, G1W 4R4Terminated
CA , QCResearch Site Quebec, QC, CA, G1V 4W2Recruiting
CA , ONResearch Site Ajax, ON, CA, L1S 2J5Recruiting
CA , ONResearch Site Barrie, ON, CA, L4M 6M2Terminated
CA , ONResearch Site Sarnia, ON, CA, N7T 4X3Terminated
CA , ONResearch Site Stouffville, ON, CA, L4A 1H2Recruiting
CA , ONResearch Site Toronto, ON, CA, M5T 3A9Recruiting
CA , ONResearch Site Toronto, ON, CA, M9V 4B4Suspended
ARResearch Site Buenos Aires, AR, S2000PBJRecruiting
ARResearch Site CABA, AR, C1012AARRecruiting
ARResearch Site Ciudad Autónoma de Buenos Aire, AR, C1440BRRSuspended
ARResearch Site Ciudad de Buenos Aires, AR, 1425Recruiting
ARResearch Site Córdoba, AR, X5003DCERecruiting
ARResearch Site Florencio Varela, AR, 1888Recruiting
ARResearch Site Florida, AR, B1602DQDRecruiting
ARResearch Site Mar del Plata, AR, B7600GWVRecruiting
ARResearch Site Mendoza, AR, M5500GIPRecruiting
ARResearch Site San Fernando, AR, B1646EBJRecruiting
ARResearch Site Tucumán, AR, 4000Recruiting
GBResearch Site Barnsley, GB, S75 3DLRecruiting
GBResearch Site Birmingham, GB, B9 5SSRecruiting
GBResearch Site Blackpool, GB, FY2 0JHRecruiting
GBResearch Site Bradford, GB, BD9 6RJRecruiting
GBResearch Site Chertsey, GB, KT16 0PZActive, not recruiting
GBResearch Site Cottingham, GB, HU16 5JQRecruiting
GBResearch Site Larbert, GB, FK5 4WRWithdrawn
GBResearch Site Leicester, GB, LE3 9QPRecruiting
GBResearch Site Manchester, GB, M13 9NQRecruiting
GBResearch Site Oxford, GB, OX3 7LERecruiting
GBResearch Site Perth, GB, PH1 1NXRecruiting
GBResearch Site Southampton, GB, SO166YDRecruiting
GBResearch Site Stockton-on-Tees, GB, TS17 6EWRecruiting
GBResearch Site Wishaw, GB, ML2 0DPRecruiting
CA , NSResearch Site Bridgewater, NS, CA, B4V 3N2Suspended
CA , NSResearch Site Lower Sackville, NS, CA, B4C 2S4Withdrawn
PHResearch Site Cavite City, PH, 4114Suspended
PHResearch Site Iloilo City, PH, 5000Recruiting
PHResearch Site Iloilo City, PH, 5000Recruiting
PHResearch Site Los Baños, PH, 4030Not yet recruiting
PHResearch Site Marilao, PH, 3019Not yet recruiting
PHResearch Site Quezon City, PH, 1100Recruiting
CZResearch Site Brandys nad Labem, CZ, 250 01Recruiting
CZResearch Site Jindrichuv Hradec, CZ, 377 01Recruiting
CZResearch Site Ostrava, CZ, 708 68Recruiting
CZResearch Site Rokycany, CZ, 337 22Recruiting
CZResearch Site Teplice, CZ, 415 01Recruiting
ESResearch Site Barcelona, ES, 08003Withdrawn
ESResearch Site Hospitalet de Llobregat(Barcel, ES, 08907Recruiting
ESResearch Site Laredo, ES, 39770Completed
ESResearch Site Madrid, ES, 28007Recruiting
ESResearch Site Madrid, ES, 28046Recruiting
ESResearch Site Madrid, ES, 28850Not yet recruiting
ESResearch Site Malaga, ES, 29010Recruiting
ESResearch Site Santander, ES, 39008Recruiting
US , OHResearch Site Cleveland, OH, US, 44106Recruiting
US , OHResearch Site Cleveland, OH, US, 44106Not yet recruiting
US , OHResearch Site Columbus, OH, US, 43215Recruiting
US , ORResearch Site Happy Valley, OR, US, 97086Withdrawn
US , ORResearch Site Medford, OR, US, 97504Completed
US , SDResearch Site Rapid City, SD, US, 57702Recruiting
US , SCResearch Site Charleston, SC, US, 29407Suspended
US , SCResearch Site Greenville, SC, US, 29615Withdrawn
US , SCResearch Site Mount Pleasant, SC, US, 29464Terminated
US , SCResearch Site North Charleston, SC, US, 29406Recruiting
US , SCResearch Site Rock Hill, SC, US, 29732Recruiting
US , SCResearch Site Spartanburg, SC, US, 29303Withdrawn
US , CAResearch Site Huntington Beach, CA, US, 92647Recruiting
US , CAResearch Site Long Beach, CA, US, 90806Withdrawn
US , CAResearch Site Los Angeles, CA, US, 90048Recruiting
US , CAResearch Site Los Angeles, CA, US, 90033Not yet recruiting
US , CAResearch Site Newport Beach, CA, US, 92663Recruiting
US , CAResearch Site Northridge, CA, US, 91324Recruiting
US , CAResearch Site Northridge, CA, US, 91324Recruiting
US , CAResearch Site Palm Springs, CA, US, 92262Recruiting
US , CAResearch Site Palm Springs, CA, US, 92262Completed
US , CAResearch Site San Diego, CA, US, 92120Withdrawn
US , CAResearch Site San Diego, CA, US, 92103Recruiting
US , CAResearch Site Westminster, CA, US, 92683Recruiting
CLResearch Site Curico, CL, 3341643Recruiting
CLResearch Site Quillota, CL, 2260000Recruiting
CLResearch Site Santiago, CL, 7500698Recruiting
CLResearch Site Santiago, CL, 7500692Recruiting
CLResearch Site Santiago, CL, 7500571Terminated
CLResearch Site Santiago, CL, 8380453Not yet recruiting
CLResearch Site Talca, CL, 3465584Recruiting
CLResearch Site Viña del Mar, CL, 2520997Withdrawn
US , FLResearch Site Brandon, FL, US, 33511Withdrawn
US , FLResearch Site Clearwater, FL, US, 33765Recruiting
US , FLResearch Site Daytona Beach, FL, US, 32117Terminated
US , FLResearch Site Edgewater, FL, US, 32132Terminated
US , FLResearch Site Jacksonville, FL, US, 32209Recruiting
US , FLResearch Site Jacksonville, FL, US, 32204Recruiting
US , FLResearch Site Kissimmee, FL, US, 34741Recruiting
US , FLResearch Site Kissimmee, FL, US, 34746Recruiting
US , FLResearch Site Leesburg, FL, US, 34748Recruiting
US , FLResearch Site Orlando, FL, US, 32819Recruiting
US , FLResearch Site Pensacola, FL, US, 32503Recruiting
US , FLResearch Site Saint Petersburg, FL, US, 33707Recruiting
US , FLResearch Site Tampa, FL, US, 33607Recruiting
US , FLResearch Site Winter Park, FL, US, 32789Recruiting
HUResearch Site Balassagyarmat, HU, 2660Recruiting
HUResearch Site Budapest, HU, 1033Recruiting
HUResearch Site Edelény, HU, 3780Recruiting
HUResearch Site Encs, HU, 3860Recruiting
HUResearch Site Gödöllő, HU, 2100Recruiting
HUResearch Site Hajdúnánás, HU, 4080Recruiting
HUResearch Site Komárom, HU, 2900Recruiting
HUResearch Site Pécs, HU, 7635Recruiting
HUResearch Site Siófok, HU, 8600Terminated
HUResearch Site Százhalombatta, HU, 2440Recruiting
HUResearch Site Szeged, HU, 6722Terminated
HUResearch Site Törökbálint, HU, 2045Recruiting
KRResearch Site Daegu, KR, 42415Recruiting
KRResearch Site Jeonju-si, KR, 54907Recruiting
KRResearch Site Seoul, KR, 06591Recruiting
KRResearch Site Seoul, KR, 03312Recruiting
KRResearch Site Seoul, KR, 05030Recruiting
KRResearch Site Seoul, KR, 04401Terminated
KRResearch Site Wonju-si, KR, 26426Recruiting
ATResearch Site Bludenz, AT, 6700Recruiting
ATResearch Site Feldbach, AT, A-8330Recruiting
ATResearch Site Grieskirchen, AT, 4710Recruiting
ATResearch Site Linz, AT, 4020Recruiting
ATResearch Site Thalheim, AT, 4600Completed
BRResearch Site Blumenau, BR, 89030-101Not yet recruiting
BRResearch Site Botucatu, BR, 18.618-686Recruiting
BRResearch Site Florianópolis, BR, 88036-800Recruiting
BRResearch Site Maringa, BR, 87015-000Recruiting
BRResearch Site Porto Alegre, BR, 90610-000Recruiting
BRResearch Site Porto Alegre, BR, 91350-200Recruiting
BRResearch Site Porto Alegre, BR, 9002-060Recruiting
BRResearch Site Porto Alegre, BR, 90020-090Recruiting
BRResearch Site Porto Alegre, BR, 90430-001Suspended
BRResearch Site Santo Andre, BR, 09080-110Recruiting
BRResearch Site Sao Bernardo do Campo, BR, 09750-420Recruiting
BRResearch Site Sao Paulo, BR, 05403-000Recruiting
BRResearch Site Sorocaba, BR, 18040-425Recruiting
BRResearch Site Uberlandia, BR, 38411-186Withdrawn
CA , SKResearch Site Saskatoon, SK, CA, S7N 0W8Recruiting
COResearch Site Barranquilla, CO, 80007Recruiting
COResearch Site Cali, CO, 76001000Recruiting
COResearch Site Floridablanca, CO, 681004Recruiting
COResearch Site Medellin, CO, 5001000Recruiting
COResearch Site Pereira, CO, 660003Recruiting
COResearch Site Rionegro, CO, 54048Withdrawn
COResearch Site Zipaquira, CO, 200251Recruiting
SEResearch Site Göteborg, SE, 413 45Recruiting
SEResearch Site Göteborg, SE, 413 46Recruiting
SEResearch Site Helsingborg, SE, 25220Suspended
SEResearch Site LUND, SE, 222 22Recruiting
SEResearch Site Malmö, SE, 205 02Recruiting
SEResearch Site Stockholm, SE, 114 46Recruiting
JPResearch Site Chuo-ku, JP, 104-0031Recruiting
JPResearch Site Chuo-ku, JP, 104-0031Terminated
JPResearch Site Chuo-ku, JP, 103-0022Recruiting
JPResearch Site Fukuoka-shi, JP, 814-0180Recruiting
JPResearch Site Himeji-shi, JP, 672-8064Terminated
JPResearch Site Hitachinaka-shi, JP, 312-0057Recruiting
JPResearch Site Joyo-shi, JP, 610-0113Recruiting
JPResearch Site Kasuga-shi, JP, 816-0813Withdrawn
JPResearch Site Kawachinagano-shi, JP, 586-8521Recruiting
JPResearch Site Kishiwada-shi, JP, 596-8501Recruiting
JPResearch Site Kobe-shi, JP, 650-0047Recruiting
JPResearch Site Koto-ku, JP, 136-0075Recruiting
JPResearch Site Kure-shi, JP, 737-0023Recruiting
JPResearch Site Matsusaka-shi, JP, 515-8544Recruiting
JPResearch Site Meguro-ku, JP, 152-8902Withdrawn
JPResearch Site Mizunami-shi, JP, 509-6134Active, not recruiting
JPResearch Site Nagaoka-shi, JP, 940-2085Recruiting
JPResearch Site Nagoya-shi, JP, 457-8511Recruiting
JPResearch Site Nishinomiya-shi, JP, 663-8501Recruiting
JPResearch Site Okayama-shi, JP, 700-8558Terminated
JPResearch Site Osaka-shi, JP, 531-0073Recruiting
JPResearch Site Sagamihara-shi, JP, 252-0315Recruiting
JPResearch Site Sakaide-shi, JP, 762-8550Recruiting
JPResearch Site Sakai-shi, JP, 591-8555Recruiting
JPResearch Site Seto-shi, JP, 489-8642Recruiting
JPResearch Site Shinagawa-ku, JP, 142-8666Recruiting
JPResearch Site Shinagawa-ku, JP, 140-8522Recruiting
JPResearch Site Toshima-ku, JP, 171-0014Recruiting
JPResearch Site Toshima-ku, JP, 170-0003Recruiting
JPResearch Site Toshima-ku, JP, 170-0002Not yet recruiting
JPResearch Site Toyonaka-shi, JP, 560-8552Recruiting
JPResearch Site Ueda-shi, JP, 386-8610Recruiting
JPResearch Site Yanagawa-shi, JP, 832-0059Recruiting
JPResearch Site Yokohama-shi, JP, 223-0059Recruiting
DEResearch Site Aachen, DE, 52074Withdrawn
DEResearch Site Bamberg, DE, 96049Recruiting
DEResearch Site Berlin, DE, 10717Recruiting
DEResearch Site Berlin, DE, 13187Recruiting
DEResearch Site Berlin, DE, 12157Recruiting
DEResearch Site Darmstadt, DE, 64283Recruiting
DEResearch Site Hamburg, DE, 20354Recruiting
DEResearch Site Hannover, DE, D-30173Recruiting
DEResearch Site Koblenz, DE, 56068Recruiting
DEResearch Site Köln, DE, 51069Recruiting
DEResearch Site Leipzig, DE, 04357Recruiting
DEResearch Site Leipzig, DE, 04207Recruiting
DEResearch Site Leipzig, DE, 04103Terminated
DEResearch Site Marburg, DE, 35037Recruiting
DEResearch Site Marburg, DE, 35037Withdrawn
DEResearch Site Neu-Isenburg, DE, 63263Recruiting
DEResearch Site Peine, DE, 31224Recruiting
DEResearch Site Potsdam, DE, 14467Recruiting
DEResearch Site Rheine, DE, 48431Completed
DEResearch Site Warendorf, DE, 48231Terminated
US , ILResearch Site Chicago, IL, US, 60611Recruiting
US , ILResearch Site Evanston, IL, US, 60201Recruiting
US , ILResearch Site O Fallon, IL, US, 62269Terminated
US , ILResearch Site Peoria, IL, US, 61636Recruiting
US , VAResearch Site Abingdon, VA, US, 24210Recruiting
US , VAResearch Site Williamsburg, VA, US, 23188Recruiting
US , NCResearch Site Burlington, NC, US, 27215Completed
US , NCResearch Site Chapel Hill, NC, US, 27517Recruiting
US , NCResearch Site Charlotte, NC, US, 28277Recruiting
US , NCResearch Site Charlotte, NC, US, 28287Suspended
US , NCResearch Site Elizabeth City, NC, US, 27909Recruiting
US , NCResearch Site Gastonia, NC, US, 28054Recruiting
US , NCResearch Site Mooresville, NC, US, 28117Terminated
US , NCResearch Site New Bern, NC, US, 28562Recruiting
US , NCResearch Site Wilmington, NC, US, 28401Recruiting
US , NCResearch Site Winston Salem, NC, US, 27103Suspended
US , TXResearch Site Amarillo, TX, US, 79124Recruiting
US , TXResearch Site Cypress, TX, US, 77429Recruiting
US , TXResearch Site Dallas, TX, US, 75390Not yet recruiting
US , TXResearch Site Fort Worth, TX, US, 76104Recruiting
US , TXResearch Site Houston, TX, US, 77079Completed
US , TXResearch Site Kerrville, TX, US, 78028Recruiting
US , TXResearch Site San Antonio, TX, US, 78258Recruiting
US , TXResearch Site Spring, TX, US, 77380Recruiting
US , TXResearch Site Tomball, TX, US, 77375Terminated
US , TXResearch Site Weatherford, TX, US, 76086Recruiting
US , MIResearch Site Farmington Hills, MI, US, 48336Recruiting
US , WAResearch Site Everett, WA, US, 98208Recruiting
US , WAResearch Site Spokane, WA, US, 99204Recruiting
PLResearch Site Białystok, PL, 15-044Recruiting
PLResearch Site Katowice, PL, 40-648Recruiting
PLResearch Site Krakow, PL, 30-510Not yet recruiting
PLResearch Site Łódź, PL, 90-153Recruiting
PLResearch Site Ostrowiec Świętokrzyski, PL, 27-400Not yet recruiting
PLResearch Site Poznań, PL, 61-578Recruiting
PLResearch Site Poznań, PL, 60-693Recruiting
PLResearch Site Proszowice, PL, 32-100Terminated
PLResearch Site Rzeszów, PL, 35-051Recruiting
PLResearch Site Skierniewice, PL, 96-100Not yet recruiting
PLResearch Site Warszawa, PL, 02-793Recruiting
PLResearch Site Wieluń, PL, 98-300Terminated
DKResearch Site Ålborg, DK, 9000Recruiting
DKResearch Site Hvidovre, DK, 2650Recruiting
DKResearch Site København NV, DK, 2400Recruiting
DKResearch Site Odense C, DK, 5000Recruiting
DKResearch Site Roskilde, DK, 4000Recruiting
DKResearch Site Vejle, DK, 7100Recruiting
ITResearch Site Catanzaro, IT, 88100Suspended
ITResearch Site Cona, IT, 44124Recruiting
ITResearch Site Genova, IT, 16132Recruiting
ITResearch Site Milano, IT, 20157Recruiting
ITResearch Site Milano, IT, 20142Recruiting
ITResearch Site NAPOLI, IT, 80131Recruiting
ITResearch Site Reggio Emilia, IT, 42123Recruiting
ITResearch Site Roma, IT, 00168Recruiting
US , NYResearch Site Bronx, NY, US, 10461Recruiting
US , NYResearch Site Bronx, NY, US, 10455Recruiting
US , NYResearch Site Buffalo, NY, US, 14215Recruiting
US , NYResearch Site New Windsor, NY, US, 12553Recruiting
US , NYResearch Site Potsdam, NY, US, 13676Recruiting
US , INResearch Site Michigan City, IN, US, 46360Completed
US , INResearch Site Valparaiso, IN, US, 46383Withdrawn
US , MDResearch Site Baltimore, MD, US, 21224Recruiting
US , MDResearch Site Columbia, MD, US, 21044Recruiting
CA , BCResearch Site Kelowna, BC, CA, V1Y 3H5Not yet recruiting
US , MOResearch Site Chesterfield, MO, US, 63017Suspended
US , MAResearch Site Boston, MA, US, 02215Recruiting
US , MAResearch Site North Dartmouth, MA, US, 02747Recruiting
US , NDResearch Site Fargo, ND, US, 58104Withdrawn
US , GAResearch Site Columbus, GA, US, 31904Recruiting
US , GAResearch Site Decatur, GA, US, 30033Recruiting
US , GAResearch Site Lawrenceville, GA, US, 30046Recruiting
US , GAResearch Site Rincon, GA, US, 31326Recruiting
US , GAResearch Site Woodstock, GA, US, 30189Withdrawn
US , CTResearch Site Stamford, CT, US, 06902Completed
US , TNResearch Site Chattanooga, TN, US, 37404Recruiting
US , TNResearch Site Franklin, TN, US, 37067Recruiting
US , TNResearch Site Hendersonville, TN, US, 37075Recruiting
AUResearch Site Caringbah, AU, 2229Recruiting
AUResearch Site Melbourne, AU, 3004Recruiting
AUResearch Site South Brisbane, AU, 4101Recruiting
AUResearch Site Southport, AU, 4215Recruiting
AUResearch Site Spearwood, AU, 6163Recruiting
NLResearch Site AMERSFOORT, NL, 3813 TZRecruiting
NLResearch Site BREDA, NL, 4818 CKRecruiting
NLResearch Site Den Bosch, NL, 5223 GZRecruiting
NLResearch Site Den Haag, NL, 2512 VAWithdrawn
NLResearch Site LEEUWARDEN, NL, 8934 ADRecruiting
NZResearch Site Auckland, NZ, 1051Recruiting
NZResearch Site Christchurch, NZ, 8013Recruiting
NZResearch Site Christchurch, NZ, 8024Recruiting
NZResearch Site Dunedin, NZ, 9016Recruiting
NZResearch Site Hamilton, NZ, 3204Recruiting
US , KYResearch Site Georgetown, KY, US, 40324Completed
US , KYResearch Site Lexington, KY, US, 40502Not yet recruiting
US , AZResearch Site Surprise, AZ, US, 85374Recruiting
US , AZResearch Site Tucson, AZ, US, 85724Recruiting
BEResearch Site Edegem, BE, 2650Recruiting
BEResearch Site Erpent, BE, 5101Recruiting
US , OKResearch Site Oklahoma City, OK, US, 73106Completed
US , IAResearch Site Council Bluffs, IA, US, 51503Withdrawn
US , IAResearch Site Iowa City, IA, US, 52242Recruiting
US , NEResearch Site Lincoln, NE, US, 68510Recruiting
US , NEResearch Site Omaha, NE, US, 68124Recruiting
US , KSResearch Site Kansas City, KS, US, 66160Recruiting
GRResearch Site Athens, GR, 11527Recruiting
GRResearch Site Athens, GR, 10676Recruiting
GRResearch Site ATHENS, GR, 11527Withdrawn
GRResearch Site ATHENS, GR, 12462Withdrawn
GRResearch Site HERAKLION, GR, 71110Withdrawn
GRResearch Site IOANNINA, GR, 45500Recruiting
GRResearch Site THESSALONIKI, GR, 57010Recruiting
GRResearch Site THESSALONIKI, GR, 56429Recruiting
US , DEResearch Site Newark, DE, US, 19713Recruiting
US , WVResearch Site Morgantown, WV, US, 26505Recruiting
US , UTResearch Site Salt Lake City, UT, US, 84102Recruiting
MXResearch Site Guadalajara, MX, 44100Recruiting
MXResearch Site Guadalajara, MX, 44130Recruiting
MXResearch Site Guadalajara, MX, 44200Not yet recruiting
MXResearch Site Mérida, MX, 97070Not yet recruiting
MXResearch Site Mexico, MX, 07760Withdrawn
MXResearch Site Mexico, MX, 06726Withdrawn
MXResearch Site Monterrey, MX, 64460Not yet recruiting
MXResearch Site Veracruz, MX, 91910Recruiting
US , NJResearch Site Brick, NJ, US, 08724Withdrawn
US , NJResearch Site Toms River, NJ, US, 08755Recruiting
US , ALResearch Site Montgomery, AL, US, 36116Withdrawn
US , WIResearch Site Cudahy, WI, US, 53110Recruiting
US , ARResearch Site Little Rock, AR, US, 72209Completed
CA , NFResearch Site St. John's, NF, CA, A1A 3R5Recruiting
CA , ABResearch Site Calgary, AB, CA, T3B 0M3Recruiting
CA , ABResearch Site Edmonton, AB, CA, T5J 3S9Withdrawn
CAResearch Site Chicoutimi, CA, G7H 5H6Recruiting
CNResearch Site Baotou, CN, 14010Recruiting
CNResearch Site Beijing, CN, 100034Recruiting
CNResearch Site Beijing, CN, 102218Not yet recruiting
CNResearch Site changsha, CN, 410015Recruiting
CNResearch Site changsha, CN, 410005Recruiting
CNResearch Site Changsha, CN, 430033Recruiting
CNResearch Site Chengdu, CN, 610041Recruiting
CNResearch Site Chengdu, CN, 610072Withdrawn
CNResearch Site Chongqing, CN, 402260Not yet recruiting
CNResearch Site Ganzhou, CN, 341000Not yet recruiting
CNResearch Site Guangzhou, CN, 510180Recruiting
CNResearch Site Guangzhou, CN, 510120Recruiting
CNResearch Site Guangzhou, CN, 510630Recruiting
CNResearch Site GUANGZHOU, CN, 510180Recruiting
CNResearch Site Guiyang, CN, 550002Recruiting
CNResearch Site Haikou, CN, 570311Recruiting
CNResearch Site hangzhou, CN, 310006Withdrawn
CNResearch Site Hebei, CN, Not yet recruiting
CNResearch Site Hefei, CN, 230001Recruiting
CNResearch Site Hohhot, CN, 010017Recruiting
CNResearch Site Hohhot, CN, 10050Not yet recruiting
CNResearch Site Kunming, CN, 650032Withdrawn
CNResearch Site Linhai, CN, 317000Recruiting
CNResearch Site Nanchang, CN, 330006Recruiting
CNResearch Site Nanchang, CN, 330006Recruiting
CNResearch Site Nanchang, CN, 330006Recruiting
CNResearch Site nanjing, CN, 210011Withdrawn
CNResearch Site Nanjing, CN, 210012Not yet recruiting
CNResearch Site Shanghai, CN, 200433Recruiting
CNResearch Site Shanghai, CN, 200002Recruiting
CNResearch Site Shanghai, CN, 200092Recruiting
CNResearch Site Shanghai, CN, 200240Withdrawn
CNResearch Site Shanghai, CN, 200032Recruiting
CNResearch Site Shenyang, CN, 110015Recruiting
CNResearch Site Shenyang, CN, 100003Withdrawn
CNResearch Site Shenzhen, CN, 518020Recruiting
CNResearch Site Shenzhen, CN, 518039Withdrawn
CNResearch Site Shijiazhuang, CN, 50051Withdrawn
CNResearch Site Suzhou, CN, 215000Recruiting
CNResearch Site Urumqi, CN, Recruiting
CNResearch Site wenzhou, CN, 325027Recruiting
CNResearch Site Wuhan, CN, Recruiting
CNResearch Site Wuhan, CN, 430030Recruiting
CNResearch Site Xi'an, CN, 710061Recruiting
CNResearch Site Yangzhou, CN, 225000Withdrawn
CNResearch Site Yanji, CN, 133000Withdrawn
CNResearch Site Yinchuan, CN, 750001Recruiting
CNResearch Site Yinchuan, CN, 750004Withdrawn
CNResearch Site Yiyang, CN, 413000Recruiting
CNResearch Site Zhanjiang, CN, 524001Recruiting
CNResearch Site Zhengzhou, CN, 450003Not yet recruiting
US , Puerto RicoResearch Site Caguas, Puerto Rico, US, 00727Not yet recruiting

Oversight


Is IND/IDE protocol: Yes 
IND/IDE Grantor: CDER 
IND/IDE Number: 100237 
Has Expanded Access: No 
U.S. FDA-regulated Drug: Yes 
U.S. FDA-regulated Device: No 

More Information


This is a poster on the Resolute study.

No publications provided

Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT04053634
Other Study ID Numbers:D3251C00014, 2019-001800-39

Keywords provided by AstraZeneca
Chronic Obstructive Pulmonary Disease
COPD
benralizumab
Fasenra
ICS
inhaled corticosteroids
exacerbations
Lung Disease
LABA/LAMA

Additional Relevant MeSH terms:
Chronic Obstructive Pulmonary Disease

Primary Outcome Measures:

  • Annualized rate of moderate or severe COPD exacerbations [ Time Frame: Over first 56 weeks ] [ Designated as safety issue:  ]
    Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD requiring:
    • Use of systemic corticosteroids for at least 3 days; and/or
    • Use of antibiotics; and/or
    • An inpatient hospitalization or death due to COPD

Secondary Outcome Measures:

  • Annualized rate of severe COPD exacerbations [ Time Frame: Minimum of 1 year and an average of 2 years ] [ Designated as safety issue:  ]
    A severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD

  • Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization [ Time Frame: Minimum of 1 year and an average of 2 years ] [ Designated as safety issue:  ]

  • Time to first COPD exacerbation [ Time Frame: During first 56 weeks ] [ Designated as safety issue:  ]

  • Change from baseline in SGRQ total and domain scores [ Time Frame: up to 56 weeks ] [ Designated as safety issue:  ]
    St. George’s Respiratory Questionnaire (SGRQ)

  • Change from baseline in E-RS:COPD total and domain scores [ Time Frame: up to 56 weeks ] [ Designated as safety issue:  ]
    Evaluating Respiratory Symptoms in COPD (E-RS:COPD)

  • Change from baseline in pre-dose/pre-bronchodilator FEV1 [ Time Frame: up to 56 weeks ] [ Designated as safety issue:  ]
    FEV1 is the Forced expiratory volume in one second at study site

  • All cause and respiratory-related mortality rate [ Time Frame: Minimum of 1 year and an average of 2 years ] [ Designated as safety issue:  ]

  • Annual rate of hospitalizations due to COPD [ Time Frame: Minimum of 1 year and an average of 2 years ] [ Designated as safety issue:  ]

  • Serum benralizumab concentration as a measure of pharmacokinetics [ Time Frame: up to 56 weeks ] [ Designated as safety issue:  ]

  • Anti-drug antibodies (ADA) as a measure of immunogenicity [ Time Frame: up to 56 weeks ] [ Designated as safety issue:  ]

  • Change from baseline in CAT total score [ Time Frame: up to 56 weeks ] [ Designated as safety issue:  ]
    Chronic Obstructive Pulmonary Disease assessment tool (CAT)

  • Length of hospital stay [ Time Frame: Minimum of 1 year and an average of 2 years ] [ Designated as safety issue:  ]

  • ICU (Intensive Care Unit) days [ Time Frame: Minimum of 1 year and an average of 2 years ] [ Designated as safety issue:  ]

  • Annual rate of hospitalizations and emergency department visits combined [ Time Frame: Minimum of 1 year and an average of 2 years ] [ Designated as safety issue:  ]

  • Annual rate of unscheduled outpatient visits including unscheduled visits to study sites [ Time Frame: Minimum of 1 year and an average of 2 years ] [ Designated as safety issue:  ]

  • Annual rate of unscheduled healthcare encounters [ Time Frame: Minimum of 1 year and and average of 2 years ] [ Designated as safety issue:  ]

Other Pre-specified Outcome Measures:

  • Safety and tolerability of benralizumab in patients with moderate to very severe COPD [ Time Frame: Minimum of 1 year and average of 2 years ] [ Designated as safety issue:  ]
    AEs, vital signs, clinical laboratory, and ECG

ArmsAssigned Interventions
Experimental: Benralizumab
Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
Biological/Vaccine: Benralizumab
Benralizumab solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.
 
Placebo Comparator: Placebo
Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
Biological/Vaccine: Placebo
Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.