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

• 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:

• 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.

Exclusion Criteria:

• 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.