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NCT05620823
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Conditions: Hidradenitis Suppurativa (HS)
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 600
Sponsor: Incyte Corporation
Location: United States
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.
Eligibility Criteria
Inclusion Criteria: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 visitsHS 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 visitsDocumented 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 contraceptionWilling and able to comply with the study protocol and procedures.Further inclusion criteria apply.Exclusion Criteria: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.
Source: ClinicalTrials.gov (NCT05620823). StuddyBuddy aggregates publicly available trial information.