INCB018424-316
Research type
Research Study
Full title
A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to < 18 Years Old) With Moderate Atopic Dermatitis
IRAS ID
1012076
Contact name
Guillaume BEAUGÉ
Contact email
Sponsor organisation
Incyte Corporation
Clinicaltrials.gov Identifier
Research summary
Ruxolitinib is an investigational drug in a cream formulation that is being studied by Incyte Corporation (“Sponsor”) for use in the treatment of atopic dermatitis (AD) commonly known as eczema.
This study is being done to evaluate the efficacy of ruxolitinib cream in children and adolescents (6 to < 18 years old) with moderate AD who have an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid and topical calcineurin inhibitor. It is expected about 240 children and adolescents will participate in this study in countries around the world.
There are three main phases, and the study will last for up to 70 weeks:Vehicle Control (VC) period (8 weeks): Participants will be randomly assigned to use either an investigational cream or a vehicle cream (a look-alike cream without the medicine) twice daily.
Open-Label Extension (OLE) Period (2 to 8 weeks, if needed): If the participant did not respond to treatment during the first 8 weeks, they may be eligible for open-label treatment with the investigational cream twice a day for 2-8 weeks. After a minimum of 2 weeks of open-label treatment, if the participant responds, they will be re-randomised to one of the two disease-controlled groups.
Disease Control (DC) Period (up to 44 weeks): If the participant responded to treatment, they will be re-randomised to use either the investigational cream or the vehicle cream twice per week to help maintain the response. If their AD flares up, they’ll use the investigational cream twice a day for 2-8 weeks until it improves, then go back to the twice-weekly cream.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0234
Date of REC Opinion
31 Mar 2026
REC opinion
Further Information Favourable Opinion