NCT03055195

Efficacy and Safety Study of Mepolizumab in Subjects With Moderate to Severe Atopic Dermatitis

Study 205050: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Mepolizumab Administered Subcutaneously in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils; thereby reducing the production and survival of eosinophils which may be therapeutic in subjects with atopic dermatitis (AD). This study will investigate the efficacy and safety of mepolizumab (100 milligram \[mg\] subcutaneous \[SC\] administered every 4 weeks) compared with placebo in adult subjects with moderate to severe atopic dermatitis (AD). Subjects will be randomized 1:1 to either placebo SC or mepolizumab SC. The study will comprise of a pre-screening period of up to approximately 4 weeks, a screening period of up to 2 weeks, followed by a 16-Week study treatment period (16 weeks with the last dose of study treatment at Week 12) and follow-up period of up to 4-week. The total duration of subject participation will be approximately 26 weeks. (Note: For subjects, who may need to stop treatment with a biologic, the total Pre-Screening and Screening period may last up to 20 weeks and total duration of participation in the study may be up to 40 weeks).

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Mepolizumab 100 mg	Mepolizumab is available as lyophilized powder in sterile vials for injection. The content is reconstituted with 1.2 milliliter (mL) Sterile Water just prior to use. Subjects will receive 1mL (100 mg/mL) bolus subcutaneous injections.
DRUG	Placebo matching mepolizumab	Placebo is available as 0.9% sodium chloride solution. Subjects will receive 1mL bolus subcutaneous injections.

Timeline

• Start date: 2017-03-21
• Primary completion: 2017-12-06
• Completion: 2017-12-06
• First posted: 2017-02-16
• Last updated: 2020-02-25
• Results posted: 2018-12-26

Locations

20 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study