A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
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.
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- Male and female participants = 18 years of age.
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- Diagnosis of moderate to severe HS = 3 months prior to Screening visit.
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- 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.
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- Total abscess and inflammatory nodule (AN) count = 5 at both the Screening and Baseline visits.
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- 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)
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- Agree to not use certain topical antiseptics on the areas affected by HS lesions during the placebo-controlled period.
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- Willingness to avoid pregnancy or fathering children.
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- Other inclusion criteria apply.
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- Draining tunnel count of \> 20 at Screening or Baseline visits.
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- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
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- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction
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- venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases
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- Q-wave interval abnormalities
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- disseminated herpes zoster or dermatomal herpes zoster
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- disseminated herpes simplex
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- chronic/recurrent infections
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- Evidence of infection with TB, HBV, HCV or HIV.
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- History of failure to JAK inhibitor treatment of any inflammatory disease.
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- Laboratory values outside of the protocol-defined ranges.
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- Other exclusion criteria apply.
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