TRuE-AD4
Research type
Research Study
Full title
A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
IRAS ID
1009764
Contact name
Guillaume BEAUGÉ
Contact email
Sponsor organisation
Incyte Corporation
Clinicaltrials.gov Identifier
Research summary
Atopic dermatitis (AD) is a chronic, recurring, inflammatory, and highly pruritic skin condition that affects up to 25% of children and up to 12% of adults worldwide. Although not life‑threatening, patients with AD are at higher risk for the development of other potentially life‑threatening disorders such as asthma and/or food allergy. Despite the availability of a number of treatment options, there is still a significant medical need for safe topical therapies that provide rapid and effective control of the signs and symptoms of AD.
The purpose of this study is to establish the efficacy and treatment effects of ruxolitinib cream 1.5% in participants with moderate atopic dermatitis who had a poor response to, were sensitive to, or were contraindicated to use both topical corticosteroid (TCS) and topical calcineurin inhibitor (TCI).
This study is double-blind, which means that during the study both participants and their study doctor will not know if participants are receiving ruxolitinib cream or the vehicle-control cream. The vehicle-control cream looks like the study cream but has no drug in it. This study is also randomised, which means participants will be randomly assigned (like flipping a coin) 2:1 to receive ruxolitinib cream or vehicle-control.
Participant involvement in this study could last for up to 34 weeks (approximately 8 months):
- Up to 28 days in screening
- 8 weeks in the vehicle-control period
- 16 weeks in the vehicle-control extension period
- around 30 days in the safety follow-up period.
There are risks involved in taking part in any research study. The most commonly seen side effects participants may experience in this study include infections (including common cold, upper respiratory tract infection, and bronchitis), headache, eczema, and burning or stinging sensation at the site of cream application.REC name
Wales REC 5
REC reference
24/WA/0116
Date of REC Opinion
11 Jun 2024
REC opinion
Further Information Favourable Opinion