A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

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%).

Timeline

Start

2021-07-19

Primary completion

2023-05-10

Completion

2024-04-08

Publications

• Eichenfield LF, Stein Gold LF, Simpson EL, Zaenglein AL, Armstrong AW, Tollefson MM, Soong W, Wine Lee L, Devani AR, Forman SB, Siri DD, Kallender H, Angel B, Li Q, Chen X, Paller AS. Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study. J Am Acad Dermatol. 2025 Sep;93(3):689-698. doi: 10.1016/j.jaad.2025.05.1385. Epub 2025 May 14.

Drugs

Indications