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STOP-HS: A Study to Evaluate the Efficacy and Safety of Povorcitinib in Participants with Moderate to Severe Hidradenitis Suppurativa
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants with Moderate to Severe Hidradenitis Suppurativa (STOP-HS)
 
Region Sponsors
California - Northern
Incyte Corporation
 
Acronym KP IRB No.
STOP-HS KPNC-2021647
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Men or women 18 years of age who have had a diagnosis of moderate to severe Hidradenitis Suppurativa.
 
Purpose
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.
 
Detailed Description
The objective of this study is to confirm the safety and efficacy profile of povorcitinib in a larger population of participants with HS as part of Phase 3 studies. The population to be studied comprises participants 18 years of age and older who have had a diagnosis of moderate to severe HS (Hurley Stage II or III) for at least 3 months and who have a 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), with HS lesions in at least 2 distinct anatomical areas and total abscess and inflammatory nodule count of at least 5.
 
Gender Age Limit
Male & Female
 
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.
 
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.

 
Keywords and/or Specific Medical Conditions
  • Dermatology
  • Internal Medicine
  • Hidradenitis Suppurativa
 
KP Clinical Facility
  • Oakland Medical Center
  • San Francisco Medical Center
 
Clinical Area
  • Dermatology
  • Internal Medicine


Principal Investigator:
Paradi Mirmirani, MD
Contact Information:
- Marina Rumore
-Marina.M.Rumore@kp.org
-Oakland Medical Center


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