A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)
Status:
Recruiting
Trial end date:
2023-10-18
Target enrollment:
Participant gender:
Summary
The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in
children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled
study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream
0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8,
efficacy will be evaluated. Participants who complete Week 8 assessments with no additional
safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same
treatment regimen, except those initially randomized to vehicle cream will be rerandomized
(1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or
1.5%).