A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT ID: NCT05620836
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
619 participants
INTERVENTIONAL
2023-02-22
2025-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Povorcitinib Dose A
Participants will receive Povorcitinib Dose A for 54 weeks.
Povorcitinib
Oral, Tablet
Povorcitinib Dose B
Participants will receive Povorcitinib Dose B for 54 weeks.
Povorcitinib
Oral, Tablet
Placebo
Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
Placebo
Oral, Tablet
Interventions
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Povorcitinib
Oral, Tablet
Placebo
Oral, Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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Investigative Site US240
Scottsdale, Arizona, United States
Investigative Site US237
Scottsdale, Arizona, United States
Investigative Site US214
Arkansas City, Arkansas, United States
Investigative Site US242
Fayetteville, Arkansas, United States
Investigative Site US223
Los Angeles, California, United States
Investigative Site US226
San Diego, California, United States
Investigative Site US222
San Francisco, California, United States
Investigative Site US233
Washington D.C., District of Columbia, United States
Investigative Site US228
Brandon, Florida, United States
Investigative Site US227
Margate, Florida, United States
Investigative Site US204
Miami, Florida, United States
Investigative Site US236
Miami, Florida, United States
Investigative Site US200
Ocala, Florida, United States
Investigative Site US201
Tampa, Florida, United States
Investigative Site US220
West Dundee, Illinois, United States
Investigative Site US206
Indianapolis, Indiana, United States
Investigative Site US241
Iowa City, Iowa, United States
Investigative Site US209
Louisville, Kentucky, United States
Investigative Site US207
Metairie, Louisiana, United States
Investigative Site US229
New Orleans, Louisiana, United States
Investigative Site US224
Baltimore, Maryland, United States
Investigative Site US208
Beverly, Massachusetts, United States
Investigative Site US221
Quincy, Massachusetts, United States
Investigative Site US213
Detroit, Michigan, United States
Investigative Site US217
Waterford, Michigan, United States
Investigative Site US212
Minneapolis, Minnesota, United States
Investigative Site US239
Omaha, Nebraska, United States
Investigative Site US230
Hightstown, New Jersey, United States
Investigative Site US202
New York, New York, United States
Investigative Site US210
Rochester, New York, United States
Investigative Site US205
Chapel Hill, North Carolina, United States
Investigative Site US215
Bexley, Ohio, United States
Investigative Site US203
Columbus, Ohio, United States
Investigative Site US232
Murfreesboro, Tennessee, United States
Investigative Site US235
Arlington, Texas, United States
Investigative Site US218
Bellaire, Texas, United States
Investigative Site US238
Pflugerville, Texas, United States
Investigative Site US234
San Antonio, Texas, United States
Investigative Site AU205
Kogarah, New South Wales, Australia
Investigative Site AU203
Kotara, New South Wales, Australia
Investigative Site AU200
Liverpool, New South Wales, Australia
Investigative Site AU202
Benowa, Queensland, Australia
Investigative Site AU206
Woolloongabba, Queensland, Australia
Investigative Site AU207
Woolloongabba, Queensland, Australia
Investigative Site AU201
Carlton, Victoria, Australia
Investigative Site AU204
Melbourne, Victoria, Australia
Investigative Site BG203
Sofia, , Bulgaria
Investigative Site BG202
Sofia, , Bulgaria
Investigative Site BG200
Sofia, , Bulgaria
Investigative Site BG204
Sofia, , Bulgaria
Investigative Site BG201
Stara Zagora, , Bulgaria
Investigative Site CA202
Calgary, Alberta, Canada
Investigative Site CA204
Edmonton, Alberta, Canada
Investigative Site CA200
Surrey, British Columbia, Canada
Investigative Site CA205
Fredericton, New Brunswick, Canada
Investigative Site CA207
Mississauga, Ontario, Canada
Investigative Site CA208
Richmond Hill, Ontario, Canada
Investigative Site CA206
Saint-Jérôme, Quebec, Canada
Investigative Site CA203
St. John's, , Canada
Investigative Site DK200
Århus N, , Denmark
Investigative Site DK201
Roskilde, , Denmark
Investigative Site FR200
Antony, , France
Investigative Site FR205
Dijon, , France
Investigative Site FR204
Lyon, , France
Investigative Site FR203
Nice, , France
Investigative Site FR206
Reims, , France
Investigative Site FR202
Rouen, , France
Investigative Site FR201
Toulon, , France
Investigative Site US225
Frankfurt am Main, MA, Germany
Investigative Site DE202
Berlin, , Germany
Investigative Site DE203
Bochum, , Germany
Investigative Site DE201
Dessau, , Germany
Investigative Site DE207
Erlangen, , Germany
Investigative Site DE208
Göttingen, , Germany
Investigative Site DE205
Heidelberg, , Germany
Investigative Site DE200
Kiel, , Germany
Investigative Site DE204
Lübeck, , Germany
Investigative Site DE206
Mainz, , Germany
Investigative Site IT200
Ancona, , Italy
Investigative Site IT204
Brescia, , Italy
Investigative Site IT207
Catania, , Italy
Investigative Site IT202
Milan, , Italy
Investigative Site IT203
Napoli, , Italy
Investigative Site IT206
Pisa, , Italy
Investigative Site IT205
Roma, , Italy
Investigative Site IT201
Rozzano, , Italy
Investigative Site PL203
Lublin, , Poland
Investigative Site PL200
Rzeszów, , Poland
Investigative Site PL201
Warsaw, , Poland
Investigative Site PL202
Warsaw, , Poland
Investigative Site ES203
Alicante, , Spain
Investigative Site ES202
Las Palmas de Gran Canaria, , Spain
Investigative Site ES204
Madrid, , Spain
Investigative Site ES201
Madrid, , Spain
Investigative Site ES205
Madrid, , Spain
Investigative Site ES200
Manises, , Spain
Investigative Site GB202
Birmingham, , United Kingdom
Investigative Site GB200
Dudley, , United Kingdom
Investigative Site GB201
Leeds, , United Kingdom
Investigative Site GB204
London, , United Kingdom
Investigative Site GB203
Salford, , United Kingdom
Countries
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Related Links
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A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Other Identifiers
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2022-501753-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB 54707-302
Identifier Type: -
Identifier Source: org_study_id
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