Povorcitinib for Hidradenitis Suppurativa

(STOP-HS1 Trial)

Recruiting at 122 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Incyte Corporation

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called Povorcitinib to see if it helps people with moderate to severe Hidradenitis Suppurativa (HS). HS is a painful skin condition that often doesn't respond well to regular treatments. Povorcitinib aims to reduce inflammation and other symptoms by calming the immune system.

Research Team

Eligibility Criteria

This trial is for people with moderate to severe Hidradenitis Suppurativa (HS) who haven't responded well to other treatments. Participants need at least 5 abscesses or nodules, must avoid certain HS treatments during the study, and agree to use contraception. It's not for those with more than 20 draining tunnels, pregnant or breastfeeding women, or individuals with specific medical conditions.

Inclusion Criteria

Agreement to use contraception

You have at least 5 abscesses and inflammatory nodules at the screening and baseline visits.

I have been diagnosed with moderate to severe HS for at least 3 months.

Exclusion Criteria

Your test results are not within the specified normal ranges.

I have more than 20 draining tunnels (fistulas).

I am not pregnant or breastfeeding.

Treatment Details

Interventions

• Placebo (Drug)
• Povorcitinib (Janus Kinase (JAK) Inhibitor)

Trial Overview The study tests Povorcitinib's effectiveness and safety in treating HS over a 12-week period against a placebo. After that, there's a 42-week extension phase. The goal is to see if Povorcitinib can help reduce symptoms of HS better than no treatment.

Participant Groups

Group I: Povorcitinib Dose B Experimental Treatment 1 Intervention

Participants will receive Povorcitinib Dose B for 54 weeks.

Group II: Povorcitinib Dose A Experimental Treatment 1 Intervention

Participants will receive Povorcitinib Dose A for 54 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.

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