Povorcitinib for Hidradenitis Suppurativa (STOP-HS2 Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Verified Trial

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 skin condition that causes painful lumps and sores. The medication aims to reduce inflammation and improve symptoms over several months, with additional follow-up.

Eligibility Criteria

Adults over 18 with moderate to severe Hidradenitis Suppurativa (HS) for at least 3 months, having lesions in two or more areas and not responding well to conventional treatments can join. They must avoid using certain antiseptics and agree to prevent pregnancy. Excluded are those with a high number of draining tunnels, serious heart issues, blood disorders, active infections like TB or HIV, or past JAK inhibitor treatment failures.

Inclusion Criteria

I am 18 years old or older.

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

I have HS and treatments so far haven't worked or I can't take them.

I agree not to use specific skin cleaners on my HS spots during the study.

I have HS lesions in at least two different body areas.

Treatment Details

The trial is testing Povorcitinib's effectiveness and safety against a placebo in treating HS over a period of 12 weeks initially. Participants will then enter an extension phase lasting another 42 weeks to gather additional data on the drug's performance.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Povorcitinib Dose BExperimental Treatment1 Intervention

Participants will receive Povorcitinib Dose B for 54 weeks.

Group II: Povorcitinib Dose AExperimental Treatment1 Intervention

Participants will receive Povorcitinib Dose A for 54 weeks.

Group III: PlaceboPlacebo Group1 Intervention

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