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
Incyte Corporation
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.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aged 6 to \< 18 years at the VC Day 1 visit. * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria. * AD duration of at least 3 months for 6 to 11 year olds and at least 2 years for 12 to \< 18 year olds (participant/parent/guardian may verbally report signs and symptoms of AD). * EASI score \> 7 at the screening and VC Day 1 visits. * IGA score of 3 at the screening and VC Day 1 visits. * Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20% at the screening and VC Day 1 visits. * Itch NRS or WI NRS score ≥ 4 at the screening…
Interventions
- DrugRuxolitinib
The study cream will be applied topically as defined in the protocol for each period.
- DrugVehicle Cream
Matching vehicle cream will be applied topically as defined in the protocol for each period.
Locations (96)
- Clinical Research Center of AlabamaBirmingham, Alabama
- Saguaro DermatologyPhoenix, Arizona
- National Jewish HealthDenver, Colorado
- Encore Medical Research, Llc HollywoodHollywood, Florida
- Lane Dermatology and Dermatologic SurgeryColumbus, Georgia
- Cleaver Medical GroupCumming, Georgia