NCT06832618

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Ruxolitinib	The study cream will be applied topically as defined in the protocol for each period.
DRUG	Vehicle Cream	Matching vehicle cream will be applied topically as defined in the protocol for each period.

Timeline

• Start date: 2025-06-17
• Primary completion: 2026-07-13
• Completion: 2028-05-18
• First posted: 2025-02-18
• Last updated: 2025-12-18

Locations

96 sites across 11 countries: United States, Belgium, Canada, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study