Ruxolitinib Cream for Hidradenitis Suppurativa

Recruiting at 108 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must not be taking: Antibiotics, Antiseptics

Disqualifiers: Infections, Cancer, Pregnancy, 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

Duration: 16 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

Research Team

Incyte Study Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for individuals who have been diagnosed with hidradenitis suppurativa (HS) for at least 6 months. They should have a minimum of four inflammatory nodules and lesions in at least two different body areas, without any draining tunnels. Participants must agree not to use antibiotics or antiseptic treatments on HS lesions during the study.

Inclusion Criteria

I agree not to use any antibiotics for HS during the initial study period.

I agree not to use antiseptic products on my HS lesions during specified study periods.

I meet other specific requirements for the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ruxolitinib 1.5% cream or vehicle cream, applied topically to the affected area

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to be monitored for long-term safety and efficacy

From Week 16 through Week 52

Treatment Details

Interventions

• Ruxolitinib Cream

Trial Overview The study tests the effectiveness and safety of ruxolitinib cream compared to a vehicle (placebo) cream in treating HS. Participants will be randomly assigned to receive either the active medication or placebo, allowing researchers to measure true treatment effects against no active ingredients.

Participant Groups

Group I: Ruxolitinib 1.5 % Cream Experimental Treatment 1 Intervention

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

Group II: Vehicle Cream Placebo Group 1 Intervention

Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

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