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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa (HS)

In brief

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.

Key facts

Study ID

NCT05620823

Run by

Incyte Corporation

People needed

608

Starts

2022-12-19

Expected to finish

2025-12-23

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigative Site DE307 — Memmingen, Germany
• Investigative Site GR300 — Athens, Greece
• Investigative Site GR303 — Athens, Greece
• Investigative Site GR301 — Thessaloniki, Greece
• Investigative Site GR302 — Thessaloniki, Greece
• Investigative Site JP304 — Itabashi-ku, Japan
• Investigative Site JP305 — Kurume-shi, Japan
• Investigative Site JP300 — Kyoto, Japan
• Investigative Site JP301 — Nakagami-gun, Japan
• Investigative Site JP303 — Niigata, Japan
• Investigative Site JP307 — Nishinomiya-shi, Japan
• Investigative Site JP308 — Sapporo, Japan
• Investigative Site JP302 — Sendai, Japan
• Investigative Site JP309 — Shinjuku-ku, Japan
• Investigative Site JP306 — Tsukuba, Japan
• Investigative Site NL302 — Breda, Netherlands
• Investigative Site US303 — Phoenix, Arizona, United States
• Investigative Site US335 — Arkansas City, Arkansas, United States
• Investigative Site US307 — Fort Smith, Arkansas, United States
• Investigative Site US315 — Laguna Niguel, California, United States
• Investigative Site US326 — Los Angeles, California, United States
• Investigative Site US323 — San Francisco, California, United States
• Investigative Site US306 — Boca Raton, Florida, United States
• Investigative Site US320 — Boca Raton, Florida, United States
• Investigative Site DE304 — Langenau, Germany

Full record on ClinicalTrials.gov

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