Efficacy and Safety Study of Mepolizumab in Subjects With Moderate to Severe Atopic Dermatitis
Status:
Terminated
Trial end date:
2017-12-06
Target enrollment:
Participant gender:
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).