drugset / Trial / NCT04921969

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

NCT04921969 ↗

Phase 3 Completed 330 enrolled Incyte Corporation

RandomizedParallel-groupTriple-blindTreatment

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

Outcome

Met primary endpoint

paper At Week 8, significantly more patients achieved IGA-TS with 0.75%/1.5% ruxolitinib cream (36.6%/56.5%) versus vehicle (10.8%; P = .0001/P < .0001). PMID 40378883 ↗

release “The Phase 3 trial of ruxolitinib cream in pediatric AD (TRuE-AD3) met its primary endpoint.” incyte.com ↗

release “Data from the TRuE-AD3 study, which build upon previously announced topline results, showed the study met its primary endpoint” incyte.com ↗

release “The TRuE-AD3 study met its primary endpoint” incyte.com ↗

release “The TRuE-AD3 study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success” incyte.com ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	0.75 %	Topical
Subject	Ruxolitinib	Small molecule	1.5 %	Topical