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Not Yet Recruiting NCT05620836

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

Conditions: Hidradenitis Suppurativa (HS)

Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 600
Sponsor: Incyte Corporation

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: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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05620836). StuddyBuddy aggregates publicly available trial information.