NCT04921969

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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%).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Ruxolitinib	The study cream will be applied topically twice a day for up to 52 weeks.
DRUG	Vehicle Cream	Matching vehicle cream will be applied topically twice a day for up to 8 weeks.

Timeline

• Start date: 2021-07-19
• Primary completion: 2023-05-10
• Completion: 2024-04-08
• First posted: 2021-06-10
• Last updated: 2025-03-28
• Results posted: 2024-06-10

Locations

67 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study