A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

• Status: Not yet recruiting
• Trial end date: 2026-01-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.

• Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits

• HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits

• Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).

• Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.

• Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.

• Agreement to use contraception

• Willing and able to comply with the study protocol and procedures.

• Further inclusion criteria apply.

Exclusion Criteria:

• Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.

• Women who are pregnant (or who are considering pregnancy) or breastfeeding.

• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.

• Laboratory values outside of the protocol-defined ranges.

• Further exclusion criteria apply.