Ruxolitinib Cream for Eczema

(TRuE-AD5 Trial)

Recruiting at 90 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Immunocompromised, Infections, Hepatitis, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for children and adolescents aged 6 to less than 18 with moderate atopic dermatitis (eczema). They must have a history of inadequate response to skin treatments, meet specific criteria for disease severity and duration, and have a certain level of itchiness. Those who've had systemic treatment or phototherapy can also join.

Inclusion Criteria

I've had treatments like steroids or light therapy for my condition in the last year.

My skin condition score is over 7 at my first visits.

My skin condition was rated as severe on two visits.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vehicle-controlled (VC) Period

Participants receive either ruxolitinib cream or vehicle cream twice daily to assess efficacy and safety

8 weeks

Regular visits for assessment

Disease Control (DC) Period

Participants receive ruxolitinib cream or vehicle cream twice weekly to manage disease exacerbations

44 weeks

Regular visits for assessment

Open-label Extension (OLE) Period

Participants may continue receiving ruxolitinib cream twice daily

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ruxolitinib Cream

Trial Overview The study tests the effectiveness and safety of ruxolitinib cream compared to a placebo (vehicle cream) in young patients with moderate atopic dermatitis. It aims to see if this topical treatment can improve their skin condition.

Participant Groups

Group I: Vehicle-controlled (VC) Period: Ruxolitinib (1.5% Cream) Experimental Treatment 1 Intervention

Study drug will be administered twice daily.

Group II: Open-label Extension (OLE) period: Ruxolitinib (1.5% Cream) Experimental Treatment 1 Intervention

Study drug will be administered twice daily.

Group III: Disease Control (DC) Period: Ruxolitinib (1.5% Cream) Experimental Treatment 1 Intervention

Study drug will be administered twice weekly.

Group IV: DC Period: Open Label - Ruxolitinib (1.5% Cream) Experimental Treatment 1 Intervention

Study drug will be administered twice daily to treat Disease Exacerbations.

Group V: VC Period: Vehicle Cream Placebo Group 1 Intervention

Matching vehicle cream will be administered twice daily.

Group VI: DC Period: Vehicle Cream Placebo Group 1 Intervention

Matching vehicle cream will be administered twice weekly.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School