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

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

2 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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%).

Key Dates

Start date

Jul 19, 2021

Status verified

Mar 2025

Primary completion

May 10, 2023

Completion

Apr 8, 2024

Study Design

Enrollment

330 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib (1.5% Cream)
  Study drug will be administered twice daiily.
• Experimental: Ruxolitinib (0.75% cream)
  Study drug will be administered twice daily.
• Placebo Comparator: Vehicle Cream
  Vehicle cream will be administered twice daily.

Primary Outcome Measure

VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 [ Time Frame: Baseline to Week 8 ]

Locations (64)

Find similar trials in Birmingham, AL

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