Efficacy and Safety Study of the Use of Benralizumab for Patients with Moderate to Severe Atopic Dermatitis

Recruitment Status:
Recruiting

Sponsor:
AstraZeneca

Collaborator:
IQVIA

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT04605094

Verification:
Verified 01 July 2021   by AstraZeneca

History of Changes:
ClinicalTrials.gov

Purpose

The purpose of the study is to compare the efficacy and safety of benralizumab versus placebo and to compare benralizumab dosing regimens during extension period.

Official Title:A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study with a 36–week Extension to Investigate the Use of Benralizumab for Patients with Moderate to Severe Atopic Dermatitis Despite Treatment with Topical Medications (The HILLIER Study)
Study Type:Interventional
Overall Recruitment Status:Recruiting
Study Start Date:12 November 2020
Study Start Date Type:Actual
Primary Completion Date:17 February 2022
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
ConditionInterventionPhase
Atopic Dermatitis
Biological/Vaccine: Benralizumab
Biological/Vaccine: Placebo / Benralizumab
Phase 2
Ages Eligible for Study: 12 Years  to 130 Years
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
1 Physician-confirmed diagnosis of AD (according to American Academy of Dermatology Consensus Criteria) that is not adequately controlled with topical medications.
2 EASI score of ≥ 12 at screening and ≥ 16 at randomization.
3 IGA score of ≥ 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at screening and at randomization.
4 Atopic dermatitis involvement of ≥ 8% body- surface area at screening and ≥ 10% body-surface area at randomization.
5 A pruritus numerical rating scale average score for maximum itch intensity of ≥ 4, based on the average of daily pruritus numerical rating scale scores for maximum itch intensity reported during the 7 days prior to randomization.
6 Documented recent history (within 6 months prior to screening) of inadequate response to treatment with topical medications, or patients for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
7 Participants that have applied a stable dose of topical emollient (moisturizer) twice daily for ≥ 7 consecutive days immediately before the randomization visit. (NOTE: See exclusion criterion 11 for limitations regarding emollients)
8 Participants must be willing and able to complete daily PRO assessments:
o Complete at least 70% of daily PRO assessments between Visit 1 and Visit 2 and
o Complete at least 5 of 7 daily PRO assessments in the 7 days prior to Visit 2.
9 Females of childbearing potential (FOCBP) must agree to use a highly effective method of birth control (confirmed by the Investigator) from randomization, throughout the study duration, and within 16 weeks after last dose of IP and have a negative serum pregnancy test result on Visit 1.
10 Females not of childbearing potential are defined as females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Females will be considered postmenopausal if they have been amenorrheic for ≥ 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
(a) Females < 50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and with follicle-stimulating hormone (FSH) levels in the postmenopausal range. Until FSH is documented to be within menopausal range, the participant should be treated as a FOCBP.
(b) Females ≥ 50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.

Exclusion Criteria:
1 Participants with active dermatological conditions (eg, psoriasis, seborrheic dermatitis, cutaneous lymphoma) other than atopic dermatitis that, in the investigator’s opinion, may interfere with the study assessments
2 Known active allergic or irritant contact dermatitis that, in the investigator’s opinion, may interfere with the study assessments
3 Current malignancy, or history of malignancy, with the exception of:
(a) Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to the date informed consent, was obtained.
(b) Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to the date informed consent, was obtained.
4 Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
(a) Affect the safety of the participant throughout the study
(b) Influence the findings of the studies or their interpretations
(c) Impede the participant’s ability to complete the entire duration of study.
5 History of anaphylaxis to any biologic therapy or vaccine
6 A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy
7 Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening/run-in period which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant’s ability to complete entire duration of the study
8 Current active liver disease:
(a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if participant otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis.
(b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 times the upper limit of normal (ULN), confirmed by repeated testing during the run-in period. Transient increase of AST/ALT level that resolves by the time of randomization is acceptable if in the Investigator’s opinion the participant does not have an active liver disease and meets other eligibility criteria.
9 A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
Prior/concomitant Therapy
10 Participants who have received treatment for AD with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase-4 (PDE4) inhibitors within the 7 days prior to the randomization visit
11 Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
12 Regular use (2 visits per week) of a tanning booth/parlor or phototherapy for AD within 4 weeks prior to the randomization visit
13 Use of immunosuppressive medication including, but not limited to: methotrexate, cyclosporine, azathioprine, systemic corticosteroids within 4 weeks or 5 half-lives prior to the date informed consent is obtained, whichever is longer.
Other
14 Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
15 Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to the date informed consent is obtained, whichever is longer
16 Receipt of live attenuated vaccines 30 days prior to first dose of IP
17 Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to the date informed consent is obtained, whichever is longer
18 Previously received benralizumab (MEDI-563, FASENRA)
19 Change to allergen immunotherapy or new allergen immunotherapy within 30 days prior to the date of informed consent and anticipated changes in immunotherapy throughout the study
20 Planned elective major surgical procedures during the conduct of the study
21 Previous randomization in the present study
22 Concurrent enrollment in another clinical trial
23 AstraZeneca staff involved in the planning and/or conduct of the study
24 For females only: Currently pregnant, breastfeeding, or lactating females
A serum pregnancy test will be done for FOCBP at Visit 1 and a urine pregnancy test must be performed for FOCBP at each subsequent treatment visit prior to IP administration. A positive urine test result must be confirmed with a serum pregnancy test. If serum test is positive, the participant should be excluded.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  

Sponsors and Collaborators

AstraZeneca
IQVIA

Investigators

Principal Investigator: Emma  Guttman , MD, PhD   Mount Sinai Hospital

Locations

CountryLocationFacilityContactStatus
Czech RepublicResearch Site Brno, Czech Republic, 602 00Recruiting
Czech RepublicResearch Site Ostrava, Czech Republic, 702 00Recruiting
Czech RepublicResearch Site Ostrava-Poruba, Czech Republic, 708 52Recruiting
Czech RepublicResearch Site Pardubice, Czech Republic, 530 02Recruiting
Czech RepublicResearch Site Praha, Czech Republic, 110 00Recruiting
Czech RepublicResearch Site Praha 10, Czech Republic, 100 00Recruiting
Czech RepublicResearch Site Praha 10, Czech Republic, 100 00Withdrawn
FranceResearch Site Brest Cedex 2, France, 29609Not Yet Recruiting
FranceResearch Site LILLE CEDEX, France, 59037Recruiting
FranceResearch Site Marseille CEDEX 5, France, 13385Not Yet Recruiting
FranceResearch Site Marseille Cedex 8, France, 13285Not Yet Recruiting
FranceResearch Site Nice cedex 3, France, 06200Not Yet Recruiting
FranceResearch Site Pierre Benite Cedex, France, 69495Not Yet Recruiting
FranceResearch Site ROUEN, France, 76031Not Yet Recruiting
FranceResearch Site Saint-Mande, France, 94160Not Yet Recruiting
PolandResearch Site Gdańsk, Poland, 80-546Recruiting
PolandResearch Site Krakow, Poland, 30-033Recruiting
PolandResearch Site Lodz, Poland, 90-302Recruiting
PolandResearch Site Osielsko, Poland, 86031Recruiting
PolandResearch Site Poznań, Poland, 60-214Recruiting
PolandResearch Site Warszawa, Poland, 01-262Recruiting
SpainResearch Site Alicante, Spain, 03010Recruiting
SpainResearch Site Barcelona, Spain, 08041Not Yet Recruiting
SpainResearch Site Cordoba, Spain, 14004Recruiting
SpainResearch Site Madrid, Spain, 28040Recruiting
SpainResearch Site Majadahonda, Spain, 28222Withdrawn
SpainResearch Site Manises, Spain, 46940Recruiting
BulgariaResearch Site Haskovo, Bulgaria, 6300Recruiting
BulgariaResearch Site Pleven, Bulgaria, 5800Recruiting
BulgariaResearch Site Ruse, Bulgaria, 7013Recruiting
BulgariaResearch Site Sofia, Bulgaria, 1000Recruiting
BulgariaResearch Site Sofia, Bulgaria, 1463Recruiting
BulgariaResearch Site Sofia, Bulgaria, 1680Recruiting
BulgariaResearch Site Sofia, Bulgaria, 1431Recruiting
United States of America , FLResearch Site Fort Myers, FL, United States of America, 33912Recruiting
United States of America , FLResearch Site Tampa, FL, United States of America, 33607Recruiting
United States of America , FLResearch Site Tampa, FL, United States of America, 33606Recruiting
South KoreaResearch Site Gwangju, South Korea, 61469Recruiting
South KoreaResearch Site Seongnam-si, South Korea, 13620Recruiting
South KoreaResearch Site Seoul, South Korea, 05505Recruiting
South KoreaResearch Site Seoul, South Korea, 06591Recruiting
South KoreaResearch Site Seoul, South Korea, 06973Recruiting
AustraliaResearch Site Fremantle, Australia, 6160Withdrawn
AustraliaResearch Site Kogarah, Australia, 2217Recruiting
AustraliaResearch Site Kotara, Australia, 2289Not Yet Recruiting
AustraliaResearch Site Parkville, Australia, 3050Recruiting
AustraliaResearch Site Phillip, Australia, 02606Withdrawn
AustraliaResearch Site Sippy Downs, Australia, 4556Recruiting
AustraliaResearch Site Woodville South, Australia, 5011Withdrawn
AustraliaResearch Site Woolloongabba, Australia, 04102Recruiting
United States of America , PAResearch Site Sugarloaf, PA, United States of America, 18249Recruiting
United States of America , MIResearch Site Ypsilanti, MI, United States of America, 48197Recruiting
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90025Recruiting
United States of America , CAResearch Site Mission Viejo, CA, United States of America, 92691Withdrawn
United States of America , CAResearch Site Newport Beach, CA, United States of America, 92663Recruiting
United States of America , CAResearch Site Westminster, CA, United States of America, 92683Recruiting
United States of America , OKResearch Site Norman, OK, United States of America, 73071Recruiting
United States of America , UTResearch Site Ogden, UT, United States of America, 84405Recruiting
United States of America , NHResearch Site Portsmouth, NH, United States of America, 03801Recruiting
United States of America , CTResearch Site Bridgeport, CT, United States of America, 06606Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10029Recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14620Recruiting
United States of America , OHResearch Site Cincinnati, OH, United States of America, 45219Recruiting
United States of America , VAResearch Site Richmond, VA, United States of America, 23226Withdrawn
United States of America , GAResearch Site Columbus, GA, United States of America, 31904Withdrawn
United States of America , AZResearch Site Phoenix, AZ, United States of America, 85006Withdrawn

No attachments posted.

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Purpose

The purpose of the study is to compare the efficacy and safety of benralizumab versus placebo and to compare benralizumab dosing regimens during extension period.

Official Title:A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study with a 36–week Extension to Investigate the Use of Benralizumab for Patients with Moderate to Severe Atopic Dermatitis Despite Treatment with Topical Medications (The HILLIER Study)
Study Type:Interventional
Overall Recruitment Status:Recruiting
Study Start Date:12 November 2020
Study Start Date Type:Actual
Primary Completion Date:17 February 2022
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
ConditionInterventionPhase
Atopic Dermatitis
Biological/Vaccine: Benralizumab
Biological/Vaccine: Placebo / Benralizumab
Phase 2
Ages Eligible for Study: 12 Years  to 130 Years
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
1 Physician-confirmed diagnosis of AD (according to American Academy of Dermatology Consensus Criteria) that is not adequately controlled with topical medications.
2 EASI score of ≥ 12 at screening and ≥ 16 at randomization.
3 IGA score of ≥ 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at screening and at randomization.
4 Atopic dermatitis involvement of ≥ 8% body- surface area at screening and ≥ 10% body-surface area at randomization.
5 A pruritus numerical rating scale average score for maximum itch intensity of ≥ 4, based on the average of daily pruritus numerical rating scale scores for maximum itch intensity reported during the 7 days prior to randomization.
6 Documented recent history (within 6 months prior to screening) of inadequate response to treatment with topical medications, or patients for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
7 Participants that have applied a stable dose of topical emollient (moisturizer) twice daily for ≥ 7 consecutive days immediately before the randomization visit. (NOTE: See exclusion criterion 11 for limitations regarding emollients)
8 Participants must be willing and able to complete daily PRO assessments:
o Complete at least 70% of daily PRO assessments between Visit 1 and Visit 2 and
o Complete at least 5 of 7 daily PRO assessments in the 7 days prior to Visit 2.
9 Females of childbearing potential (FOCBP) must agree to use a highly effective method of birth control (confirmed by the Investigator) from randomization, throughout the study duration, and within 16 weeks after last dose of IP and have a negative serum pregnancy test result on Visit 1.
10 Females not of childbearing potential are defined as females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Females will be considered postmenopausal if they have been amenorrheic for ≥ 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
(a) Females < 50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and with follicle-stimulating hormone (FSH) levels in the postmenopausal range. Until FSH is documented to be within menopausal range, the participant should be treated as a FOCBP.
(b) Females ≥ 50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.

Exclusion Criteria:
1 Participants with active dermatological conditions (eg, psoriasis, seborrheic dermatitis, cutaneous lymphoma) other than atopic dermatitis that, in the investigator’s opinion, may interfere with the study assessments
2 Known active allergic or irritant contact dermatitis that, in the investigator’s opinion, may interfere with the study assessments
3 Current malignancy, or history of malignancy, with the exception of:
(a) Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to the date informed consent, was obtained.
(b) Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to the date informed consent, was obtained.
4 Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
(a) Affect the safety of the participant throughout the study
(b) Influence the findings of the studies or their interpretations
(c) Impede the participant’s ability to complete the entire duration of study.
5 History of anaphylaxis to any biologic therapy or vaccine
6 A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy
7 Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening/run-in period which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant’s ability to complete entire duration of the study
8 Current active liver disease:
(a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if participant otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis.
(b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 times the upper limit of normal (ULN), confirmed by repeated testing during the run-in period. Transient increase of AST/ALT level that resolves by the time of randomization is acceptable if in the Investigator’s opinion the participant does not have an active liver disease and meets other eligibility criteria.
9 A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
Prior/concomitant Therapy
10 Participants who have received treatment for AD with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase-4 (PDE4) inhibitors within the 7 days prior to the randomization visit
11 Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
12 Regular use (2 visits per week) of a tanning booth/parlor or phototherapy for AD within 4 weeks prior to the randomization visit
13 Use of immunosuppressive medication including, but not limited to: methotrexate, cyclosporine, azathioprine, systemic corticosteroids within 4 weeks or 5 half-lives prior to the date informed consent is obtained, whichever is longer.
Other
14 Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
15 Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to the date informed consent is obtained, whichever is longer
16 Receipt of live attenuated vaccines 30 days prior to first dose of IP
17 Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to the date informed consent is obtained, whichever is longer
18 Previously received benralizumab (MEDI-563, FASENRA)
19 Change to allergen immunotherapy or new allergen immunotherapy within 30 days prior to the date of informed consent and anticipated changes in immunotherapy throughout the study
20 Planned elective major surgical procedures during the conduct of the study
21 Previous randomization in the present study
22 Concurrent enrollment in another clinical trial
23 AstraZeneca staff involved in the planning and/or conduct of the study
24 For females only: Currently pregnant, breastfeeding, or lactating females
A serum pregnancy test will be done for FOCBP at Visit 1 and a urine pregnancy test must be performed for FOCBP at each subsequent treatment visit prior to IP administration. A positive urine test result must be confirmed with a serum pregnancy test. If serum test is positive, the participant should be excluded.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  

Sponsors and Collaborators

AstraZeneca
IQVIA

Investigators

Principal Investigator: Emma  Guttman , MD, PhD   Mount Sinai Hospital

Locations

CountryLocationFacilityContactStatus
Czech RepublicResearch Site Brno, Czech Republic, 602 00Recruiting
Czech RepublicResearch Site Ostrava, Czech Republic, 702 00Recruiting
Czech RepublicResearch Site Ostrava-Poruba, Czech Republic, 708 52Recruiting
Czech RepublicResearch Site Pardubice, Czech Republic, 530 02Recruiting
Czech RepublicResearch Site Praha, Czech Republic, 110 00Recruiting
Czech RepublicResearch Site Praha 10, Czech Republic, 100 00Recruiting
Czech RepublicResearch Site Praha 10, Czech Republic, 100 00Withdrawn
FranceResearch Site Brest Cedex 2, France, 29609Not Yet Recruiting
FranceResearch Site LILLE CEDEX, France, 59037Recruiting
FranceResearch Site Marseille CEDEX 5, France, 13385Not Yet Recruiting
FranceResearch Site Marseille Cedex 8, France, 13285Not Yet Recruiting
FranceResearch Site Nice cedex 3, France, 06200Not Yet Recruiting
FranceResearch Site Pierre Benite Cedex, France, 69495Not Yet Recruiting
FranceResearch Site ROUEN, France, 76031Not Yet Recruiting
FranceResearch Site Saint-Mande, France, 94160Not Yet Recruiting
PolandResearch Site Gdańsk, Poland, 80-546Recruiting
PolandResearch Site Krakow, Poland, 30-033Recruiting
PolandResearch Site Lodz, Poland, 90-302Recruiting
PolandResearch Site Osielsko, Poland, 86031Recruiting
PolandResearch Site Poznań, Poland, 60-214Recruiting
PolandResearch Site Warszawa, Poland, 01-262Recruiting
SpainResearch Site Alicante, Spain, 03010Recruiting
SpainResearch Site Barcelona, Spain, 08041Not Yet Recruiting
SpainResearch Site Cordoba, Spain, 14004Recruiting
SpainResearch Site Madrid, Spain, 28040Recruiting
SpainResearch Site Majadahonda, Spain, 28222Withdrawn
SpainResearch Site Manises, Spain, 46940Recruiting
BulgariaResearch Site Haskovo, Bulgaria, 6300Recruiting
BulgariaResearch Site Pleven, Bulgaria, 5800Recruiting
BulgariaResearch Site Ruse, Bulgaria, 7013Recruiting
BulgariaResearch Site Sofia, Bulgaria, 1000Recruiting
BulgariaResearch Site Sofia, Bulgaria, 1463Recruiting
BulgariaResearch Site Sofia, Bulgaria, 1680Recruiting
BulgariaResearch Site Sofia, Bulgaria, 1431Recruiting
United States of America , FLResearch Site Fort Myers, FL, United States of America, 33912Recruiting
United States of America , FLResearch Site Tampa, FL, United States of America, 33607Recruiting
United States of America , FLResearch Site Tampa, FL, United States of America, 33606Recruiting
South KoreaResearch Site Gwangju, South Korea, 61469Recruiting
South KoreaResearch Site Seongnam-si, South Korea, 13620Recruiting
South KoreaResearch Site Seoul, South Korea, 05505Recruiting
South KoreaResearch Site Seoul, South Korea, 06591Recruiting
South KoreaResearch Site Seoul, South Korea, 06973Recruiting
AustraliaResearch Site Fremantle, Australia, 6160Withdrawn
AustraliaResearch Site Kogarah, Australia, 2217Recruiting
AustraliaResearch Site Kotara, Australia, 2289Not Yet Recruiting
AustraliaResearch Site Parkville, Australia, 3050Recruiting
AustraliaResearch Site Phillip, Australia, 02606Withdrawn
AustraliaResearch Site Sippy Downs, Australia, 4556Recruiting
AustraliaResearch Site Woodville South, Australia, 5011Withdrawn
AustraliaResearch Site Woolloongabba, Australia, 04102Recruiting
United States of America , PAResearch Site Sugarloaf, PA, United States of America, 18249Recruiting
United States of America , MIResearch Site Ypsilanti, MI, United States of America, 48197Recruiting
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90025Recruiting
United States of America , CAResearch Site Mission Viejo, CA, United States of America, 92691Withdrawn
United States of America , CAResearch Site Newport Beach, CA, United States of America, 92663Recruiting
United States of America , CAResearch Site Westminster, CA, United States of America, 92683Recruiting
United States of America , OKResearch Site Norman, OK, United States of America, 73071Recruiting
United States of America , UTResearch Site Ogden, UT, United States of America, 84405Recruiting
United States of America , NHResearch Site Portsmouth, NH, United States of America, 03801Recruiting
United States of America , CTResearch Site Bridgeport, CT, United States of America, 06606Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10029Recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14620Recruiting
United States of America , OHResearch Site Cincinnati, OH, United States of America, 45219Recruiting
United States of America , VAResearch Site Richmond, VA, United States of America, 23226Withdrawn
United States of America , GAResearch Site Columbus, GA, United States of America, 31904Withdrawn
United States of America , AZResearch Site Phoenix, AZ, United States of America, 85006Withdrawn

Oversight


Is FDA regulated intervention: Yes 
Is IND/IDE protocol: Yes 
Section 801 trial: Yes 
IND/IDE Grantor: CBER 
IND/IDE Number: 143952 
Has Expanded Access: No 
U.S. FDA-regulated Drug: Yes 
U.S. FDA-regulated Device: No 

More Information


No publications provided

Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT04605094
Other Study ID Numbers:D3256C00001

Keywords provided by AstraZeneca
Moderate to severe atopic dermatitis
pruritus
skin lesion

Additional Relevant MeSH terms:
Atopic Dermatitis

Primary Outcome Measures:

  • Proportion of patients with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 16 relative to baseline [ Time Frame: Week 16 for all patients ] [ Designated as safety issue:  ]
    Scale Title: Investigator Global Assessment Score (IGA)
    Minimum Value: 0 – Clear
    Maximum Value: 4 – Severe
    High score means a worse outcome

Secondary Outcome Measures:

  • Proportion of patients with skin clearance (EASI-75) [ Time Frame: Week 16 for all patients ] [ Designated as safety issue:  ]
    Scale Title: Eczema Area and Severity Index (EASI)
    Area Score:
    Minimum Value: 0 – No active eczema in this region
    Maximum Value: 6 – The entire region is affected by eczema
    Severity Score:
    Minimum Value: 0 – None
    Maximum Value: 3 – Severe
    High score means a worse outcome

  • Serum benralizumab concentration and anti-drug antibodies (ADA) [ Time Frame: Week 16 for all patients ] [ Designated as safety issue:  ]

  • Proportion of patients with skin clearance (EASI-90) [ Time Frame: Week 16 for all patients ] [ Designated as safety issue:  ]
    Scale Title: Eczema Area and Severity Index (EASI)
    Area Score:
    Minimum Value: 0 – No active eczema in this region
    Maximum Value: 6 – The entire region is affected by eczema
    Severity Score:
    Minimum Value: 0 – None
    Maximum Value: 3 – Severe
    High score means a worse outcome

  • Proportion of patients with an improvement of ≥ 4 or more points in peak pruritus weekly score [ Time Frame: Week 16 for all patients ] [ Designated as safety issue:  ]
    Scale Title: Peak Pruritus Rating Scale
    Minimum Value: 0 – No itch
    Maximum Value: 10 – Worst itch imaginable
    High score means a worse outcome

  • Change from baseline in DLQI and CDLQI [ Time Frame: Week 16 for all patients ] [ Designated as safety issue:  ]
    Scale Title: Dermatology Life Quality Index
    Minimum Value – Not at all/Not relevant
    Maximum Value – Very much

    Scale Title: Children’s Dermatology Life Quality Index
    Minimum Value – Not at all
    Maximum Value – Very much
    High score means a worse outcome

Other Pre-specified Outcome Measures:

  • [ Time Frame:  ] [ Designated as safety issue:  ]

ArmsAssigned Interventions
Experimental: Benralizumab
Biological/Vaccine: Benralizumab
Benralizumab by subcutaneous injection until Week 16, and then benralizumab by subcutaneous injection during the extension period.
Other Name: Benralizumab, Benra, Fasenra
 
Experimental: Placebo / Benralizumab
Biological/Vaccine: Placebo / Benralizumab
Placebo by subcutaneous injection until Week 16, then benralizumab by subcutaneous injection until Week 52.
Other Name: Benralizumab, Benra, Fasenra