Ruxolitinib Cream for Hidradenitis Suppurativa

(TRuE-HS2 Trial)

Recruiting at 107 trial locations

Overseen By Incyte Corporation Call Center (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

450 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. Participants must have a minimum of four inflammatory nodules and abscesses, affecting two different body areas. They cannot use topical or systemic antibiotics, nor antiseptic washes on HS lesions during the study.

Inclusion Criteria

My condition affects at least two different parts of my body.

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

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

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 Period

Participants may continue to receive treatment and be monitored for long-term outcomes

36 weeks

Treatment Details

Interventions

• Ruxolitinib Cream

Trial Overview The study tests ruxolitinib cream's effectiveness and safety against a placebo (vehicle cream) in treating HS. Participants will be randomly assigned to receive either the active medication or placebo to compare outcomes.

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