A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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