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

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

NCT05620836

Run by

Incyte Corporation

People needed

619

Starts

2023-02-22

Expected to finish

2025-11-21

Last updated by the study team

2026-01-09

Who can join

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

You may qualify if…

• Male and female participants ≥ 18 years of age.
• Diagnosis of moderate to severe HS ≥ 3 months prior to Screening visit.
• HS lesions present in ≥ 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the Screening and Baseline visits.
• Total abscess and inflammatory nodule (AN) count ≥ 5 at both the Screening and Baseline visits.
• History of inadequate response to an appropriate course of at least 1 conventional systemic therapy for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for HS)
• Agree to not use certain topical antiseptics on the areas affected by HS lesions during the placebo-controlled period.
• Willingness to avoid pregnancy or fathering children.
• Other inclusion criteria apply.

You may not qualify if…

• Draining tunnel count of > 20 at Screening or Baseline visits.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
• Evidence of infection with TB, HBV, HCV or HIV.
• History of failure to JAK inhibitor treatment of any inflammatory disease.
• Laboratory values outside of the protocol-defined ranges.
• Other exclusion criteria apply.

Where it is running

• Investigative Site US237 — Scottsdale, Arizona, United States
• Investigative Site US214 — Arkansas City, Arkansas, United States
• Investigative Site US242 — Fayetteville, Arkansas, United States
• Investigative Site US223 — Los Angeles, California, United States
• Investigative Site US226 — San Diego, California, United States
• Investigative Site US222 — San Francisco, California, United States
• Investigative Site US233 — Washington D.C., District of Columbia, United States
• Investigative Site US228 — Brandon, Florida, United States
• Investigative Site US227 — Margate, Florida, United States
• Investigative Site US204 — Miami, Florida, United States
• Investigative Site US236 — Miami, Florida, United States
• Investigative Site US200 — Ocala, Florida, United States
• Investigative Site US201 — Tampa, Florida, United States
• Investigative Site US220 — West Dundee, Illinois, United States
• Investigative Site US206 — Indianapolis, Indiana, United States
• Investigative Site US241 — Iowa City, Iowa, United States
• Investigative Site US209 — Louisville, Kentucky, United States
• Investigative Site US207 — Metairie, Louisiana, United States
• Investigative Site US229 — New Orleans, Louisiana, United States
• Investigative Site US224 — Baltimore, Maryland, United States
• Investigative Site US208 — Beverly, Massachusetts, United States
• Investigative Site US221 — Quincy, Massachusetts, United States
• Investigative Site US213 — Detroit, Michigan, United States
• Investigative Site US217 — Waterford, Michigan, United States
• Investigative Site US240 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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