Hidradenitis Suppurativa (Incyte Oral Study)

Study Description

Brief 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.

Condition or Disease

Hidradenitis Suppurativa

Study Design

Study Type: Interventional (Clinical Trial)
EstimatedĀ Enrollment: 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
ActualĀ Study Start Date: December 19, 2022
EstimatedĀ Primary Completion Date: March 11, 2025
EstimatedĀ Study Completion Date: January 30, 2026

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

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 visits
  • HS 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 visits
  • Documented 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 contraception
  • Willing 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.