Overview
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.
Eligibility
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.