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Monoclonal Antibodies
Benralizumab for Atopic Dermatitis
Phase 2
Waitlist Available
Led By Emma Guttman, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Physician-confirmed diagnosis of AD (according to American Academy of Dermatology Consensus Criteria) that is not adequately controlled with topical medications.
EASI score of ≥ 12 at screening and ≥ 16 at randomization.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16
Awards & highlights
Study Summary
This trial will compare the effectiveness and safety of two different doses of a new asthma medication, versus a placebo.
Eligible Conditions
- Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With an Investigator Global Assessment (IGA) 0/1 and a Decrease in IGA of ≥2 Points at Week 16 Relative to Baseline
Secondary outcome measures
Percentage of Participants Who Experienced 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
Percentage of Participants Who Experienced 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16
Percentage of Participants With an Improvement of ≥4 or More Points in Peak Pruritus Weekly Score
Side effects data
From 2016 Phase 3 trial • 220 Patients • NCT0207525516%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo / BenralizumabExperimental Treatment1 Intervention
Group II: BenralizumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 3
~10580
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,708 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
169,814 Total Patients Enrolled
Emma Guttman, MD, PhDPrincipal InvestigatorMOUNT SINAI HOSPITAL
6 Previous Clinical Trials
193 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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