D3256C00001

AstraZeneca

Karlebyhusentren, B674 Astraallen, Södertälje, Sweden, 151 85

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com

No

Yes

Final

13 Sep 2022

No

Yes

13 Sep 2022

Yes

The purpose of this study was to compare the clinical efficacy of benralizumab 30 milligram (mg) with placebo in participants with atopic dermatitis (AD) despite treatment with topical medications.

This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/Good Clinical Practice (GCP), applicable regulatory requirements, and the AstraZeneca policy on Bioethics.

12 Nov 2020

No

Yes

Bulgaria: 12

Czechia: 28

Spain: 22

France: 5

Poland: 38

United States: 39

Australia: 12

Korea, Republic of: 38

194

105

0

0

0

0

0

53

133

8

0

Overall study (overall period)

Randomised - controlled

Yes

Benralizumab

Solution for injection in pre-filled syringe

Subcutaneous use

Benralizumab was administered as a SC injection of 1 milliliter (mL) volume containing 30 mg dose to participants by health care professionals in arms, abdominal wall and thighs in rotation.

Placebo

Solution for injection in pre-filled syringe

Subcutaneous use

A matching placebo was administered as a SC injection to participants by health care professionals in arms, abdominal wall and thighs in rotation.

Benralizumab

Placebo

Benralizumab

Placebo

Benralizumab Q4W -> Q4W

Participants received benralizumab 30 mg SC injection on Day 1 visit Q4W until Week 16 visit. In extension phase, these participants again received benralizumab 30 mg SC injection Q4W until Week 52 visit.

Benralizumab Q4W -> Q8W

Participants received benralizumab 30 mg SC injection on Day 1 visit Q4W until Week 16 visit. In extension phase, these participants received benralizumab 30 mg SC injection Q8W until Week 52 visit.

The IGA is an instrument used in clinical studies to rate the severity of atopic dermatitis globally, based on a 5-point scale ranging from 0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease; 4 = severe disease. The IGA used clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. A higher score indicated greater severity. A responder at Week 16 was defined as having IGA 0/1 and a decrease in IGA of ≥2 points at Week 16 relative to baseline. Participants who withdrew from the study/required rescue therapy after Day 28 were considered as non-responders from the time these events occurred. Baseline was defined as the last recorded value on or prior to the date of randomization. The Full Analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.

Primary

Baseline (Week 0) and at Week 16

Estimates were from a logistic regression model that included treatment group, age as recorded on electronic case report form (eCRF) at screening (>=12 to <18 years; >=18 years), blood eosinophils as recorded on eCRF at screening (<300 cells/microliters [µL]; >=300 cells/µL) and baseline value of IGA score.

Benralizumab v Placebo

194

Pre-specified

-8.62

2-sided

The EASI assessed the severity and extent of AD. Severity of 4 AD disease characteristics (erythema, induration/papulation, excoriation [scratching], lichenification) each were assessed on a scale of 0 (absent) to 3 (severe) in each of 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Total body total score=sum of the region total scores; ranged from 0 to 72. Participants were classified as responders if they achieved at least 75/90% reduction from baseline in their EASI total score at Week 16. Participants who withdrew from study/required rescue therapy after Day 28 were non-responders from the time these events occurred. Higher scores indicated a more severe or more extensive condition. Baseline was defined as the last recorded value on or prior to the date of randomization. The FAS consisted of all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.

Secondary

Baseline (Week 0) and at Week 16

Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (>=12 to < 18 years; >=18 years), blood eosinophils as recorded on eCRF at screening (<300 cells/µL; >=300 cells/µL) and baseline EASI total score.

Benralizumab v Placebo

194

Pre-specified

-5.15

2-sided

Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (>=12 to < 18 years; >=18 years), blood eosinophils as recorded on eCRF at screening (<300 cells/µL; >=300 cells/µL) and baseline EASI total score.

Benralizumab v Placebo

194

Pre-specified

-8.18

2-sided

The Peak Pruritus numeric rating scale (NRS) was a 1-item daily assessment of the worst itch the participant experienced over the past 24 hours. The score ranged from 0 to 10, with 0 being “no itch” and 10 being “worst itch imaginable.” and so a reduction in score was considered an improvement. A responder was defined as having an improvement of 4 or more points relative to baseline. Participants who withdrew from the study/required rescue therapy after Day 28 were considered as non-responders from the time these events occurred. The Week 16 weekly scores were defined as the average of the daily scores for the 7 days prior to the weekly score. The FAS consisted of all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.

Secondary

At Week 16

Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (>=12 to < 18 years; >=18 years), blood eosinophils as recorded on eCRF at screening (<300 cells/µL; >=300 cells/µL) and baseline Peak Pruritus score.

Benralizumab v Placebo

194

Pre-specified

0.69

2-sided

Adverse events in the on-study period were reported from the first dose of study treatment (Day 1) up to end of follow-up, approximately a maximum up to Week 60

The Safety Analysis set consisted of all participants who received at least 1 dose of study drug.

24.1

Benralizumab

Placebo