CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Benralizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03563066
NCT03563066Phase 2Completed

Benralizumab Regulates Atopic Dermatitis Through Effects on Eosinophils, Basophils and Innate Lymphoid Type 2 Cells.

McMaster University·interventional·Posted Jun 20, 2018·Updated Aug 22, 2025

In Brief

A Phase 2 clinical trial evaluating Benralizumab and Placebo Control for Dermatitis, Atopic and 9 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy lesions. The prevalence of AD has increased over the past few decades, with 15-30% of children and 2-10%of adults being affected. The lesions of AD patients are very inflamed, with an increased number of inflammatory cells in the skin. There are not many medications available that are fully effective and can be used long-term for treatment of atopic dermatitis. Benralizumab is a monoclonal antibody used for treatment of a type of asthma called "eosinophilic asthma". Atopic dermatitis is also associated with elevated levels of eosinophils, and we would like to determine if benralizumab is effective in patients with atopic dermatitis. This is a randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of 3 doses of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks to patients with moderate-to-severe atopic dermatitis, on the severity of atopic dermatitis, and the cellular inflammation of skin lesions in these patients. Anti-inflammatory properties of benralizumab when a skin flare is induced in a controlled laboratory setting, in addition to the effects of benralizumab on skin that is already inflamed will be examined.It is hypothesized that benralizumab will attenuate eosinophilic inflammation in the skin.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 20, 2018
Enrollment StartSep 4, 2018
Primary CompletionSep 28, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.0 years ago

Interventions

Benralizumabdrug

Subcutaneous benralizumab injections once per month for 3 months on Days 0, 28 \& 56.

Placebo Controldrug

Subcutaneous placebo injections once per month for 3 months on Days 0, 28 \& 56.