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

Last updated: March 24, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hidradenitis Suppurativa

Rosacea

Acne Inversa

Treatment

Placebo

Povorcitinib

Clinical Study ID

NCT05620836
INCB 54707-302
  • Ages > 18
  • All Genders

Study 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

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 leastHurley 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 andBaseline visits.

  • History of inadequate response to an appropriate course of at least 1 conventionalsystemic therapy for HS (or demonstrated intolerance to, or have a contraindicationto, a conventional systemic therapy for HS)

  • Agree to not use certain topical antiseptics on the areas affected by HS lesionsduring the placebo-controlled period.

  • Willingness to avoid pregnancy or fathering children.

  • Other inclusion criteria apply.

Exclusion

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.

Study Design

Total Participants: 619
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 22, 2023
Estimated Completion Date:
January 30, 2026

Connect with a study center

  • Investigative Site AU205

    Kogarah, New South Wales 02217
    Australia

    Site Not Available

  • Investigative Site AU203

    Kotara, New South Wales 02289
    Australia

    Site Not Available

  • Investigative Site AU200

    Liverpool, New South Wales 02170
    Australia

    Site Not Available

  • Investigative Site AU202

    Benowa, Queensland 04217
    Australia

    Site Not Available

  • Investigative Site AU206

    Woolloongabba, Queensland 04102
    Australia

    Site Not Available

  • Investigative Site AU207

    Woolloongabba, Queensland 04102
    Australia

    Site Not Available

  • Investigative Site AU201

    Carlton, Victoria 03053
    Australia

    Site Not Available

  • Investigative Site AU204

    Melbourne, Victoria 03002
    Australia

    Site Not Available

  • Investigative Site BG200

    Sofia, 01510
    Bulgaria

    Site Not Available

  • Investigative Site BG202

    Sofia, 01463
    Bulgaria

    Site Not Available

  • Investigative Site BG203

    Sofia, 01407
    Bulgaria

    Site Not Available

  • Investigative Site BG204

    Sofia, 01606
    Bulgaria

    Site Not Available

  • Investigative Site BG201

    Stara Zagora, 06000
    Bulgaria

    Site Not Available

  • Investigative Site CA202

    Calgary, Alberta T3E 0B2
    Canada

    Site Not Available

  • Investigative Site CA204

    Edmonton, Alberta T6G 1C3
    Canada

    Site Not Available

  • Investigative Site CA200

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Investigative Site CA205

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Investigative Site CA207

    Mississauga, Ontario L4W 0C2
    Canada

    Site Not Available

  • Investigative Site CA208

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • Investigative Site CA206

    ST-J�R�ME, Quebec J7Z 7E2
    Canada

    Site Not Available

  • Investigative Site CA206

    St-jerome, Quebec J7Z 7E2
    Canada

    Site Not Available

  • Investigative Site CA206

    St-jérôme, Quebec J7Z 7E2
    Canada

    Site Not Available

  • Investigative Site CA209

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • Investigative Site CA203

    St. John's, A1A 4Y3
    Canada

    Site Not Available

  • Investigative Site DK200

    AaRHUS N, 08200
    Denmark

    Site Not Available

  • Investigative Site DK201

    Roskilde, 04000
    Denmark

    Site Not Available

  • Investigative Site DK200

    Århus N, 08200
    Denmark

    Site Not Available

  • Investigative Site DK200

    �RHUS N, 08200
    Denmark

    Site Not Available

  • Investigative Site FR200

    Antony, 92160
    France

    Site Not Available

  • Investigative Site FR205

    Dijon, 21000
    France

    Site Not Available

  • Investigative Site FR204

    Lyon, 69003
    France

    Site Not Available

  • Investigative Site FR203

    Nice Cedex 3, 06200
    France

    Site Not Available

  • Investigative Site FR206

    Reims, 51100
    France

    Site Not Available

  • Investigative Site FR202

    Rouen Cedex, 76031
    France

    Site Not Available

  • Investigative Site FR201

    Toulon, 83000
    France

    Site Not Available

  • Investigative Site US225

    Frankfurt Am Main, MA 60590
    Germany

    Site Not Available

  • Investigative Site DE202

    Berlin, 10117
    Germany

    Site Not Available

  • Investigative Site DE203

    Bochum, 44791
    Germany

    Site Not Available

  • Investigative Site DE201

    Dessau, 06847
    Germany

    Site Not Available

  • Investigative Site DE207

    Erlangen, 91054
    Germany

    Site Not Available

  • Investigative Site DE208

    Goettingen, 37075
    Germany

    Site Not Available

  • Investigative Site DE208

    Gottingen, 37075
    Germany

    Site Not Available

  • Investigative Site DE205

    Heidelberg, 69120
    Germany

    Site Not Available

  • Investigative Site DE200

    Kiel, 24105
    Germany

    Site Not Available

  • Investigative Site DE204

    Luebeck, 23538
    Germany

    Site Not Available

  • Investigative Site DE206

    Mainz, 55131
    Germany

    Site Not Available

  • Investigative Site IT200

    Ancona, 60126
    Italy

    Site Not Available

  • Investigative Site IT204

    Brescia, 25124
    Italy

    Site Not Available

  • Investigative Site IT207

    Catania, 95123
    Italy

    Site Not Available

  • Investigative Site IT202

    Milano, 20122
    Italy

    Site Not Available

  • Investigative Site IT203

    Napoli, 80131
    Italy

    Site Not Available

  • Investigative Site IT206

    Pisa, 56126
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Roma, 00168
    Italy

    Active - Recruiting

  • Investigative Site IT205

    Roma, 00168
    Italy

    Site Not Available

  • Investigative Site IT201

    Rozzano, 20089
    Italy

    Site Not Available

  • Investigative Site PL203

    Lublin, 20573
    Poland

    Site Not Available

  • Investigative Site PL200

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Kliniczny Szpital Wojewodzki Nr 1 Im.F.Chopina

    Rzeszow, 35-055
    Poland

    Active - Recruiting

  • Investigative Site PL201

    Warszawa, 02-507
    Poland

    Site Not Available

  • Investigative Site PL202

    Warszawa, 02-962
    Poland

    Site Not Available

  • Investigative Site ES203

    Alicante, 03010
    Spain

    Site Not Available

  • Investigative Site ES202

    Las Palmas de Gran Canaria, 35019
    Spain

    Site Not Available

  • Investigative Site ES201

    Madrid, 28007
    Spain

    Site Not Available

  • Investigative Site ES204

    Madrid, 28005
    Spain

    Site Not Available

  • Investigative Site ES205

    Madrid, 28040
    Spain

    Site Not Available

  • Investigative Site ES200

    Manises, 46940
    Spain

    Site Not Available

  • Investigative Site GB202

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Investigative Site GB200

    Dudley, DY1 2HQ
    United Kingdom

    Site Not Available

  • Investigative Site GB201

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Investigative Site GB204

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Investigative Site GB203

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Investigative Site US237

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Investigative Site US240

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Investigative Site US214

    Arkansas, Arkansas 72758
    United States

    Site Not Available

  • Investigative Site US242

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Investigative Site US231

    Little Rock, Arkansas 72205-7199
    United States

    Site Not Available

  • Investigative Site US223

    Los Angeles, California 90033
    United States

    Site Not Available

  • Investigative Site US226

    San Diego, California 92103
    United States

    Site Not Available

  • Investigative Site US222

    San Francisco, California 94118
    United States

    Site Not Available

  • Investigative Site US233

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Investigative Site US228

    Brandon, Florida 33511
    United States

    Site Not Available

  • Investigative Site US227

    Margate, Florida 33063
    United States

    Site Not Available

  • Investigative Site US204

    Miami, Florida 33125
    United States

    Site Not Available

  • Investigative Site US236

    Miami, Florida 33173
    United States

    Site Not Available

  • Investigative Site US200

    Ocala, Florida 34470
    United States

    Site Not Available

  • Investigative Site US201

    Tampa, Florida 33613
    United States

    Site Not Available

  • Dundee Dermatology

    West Dundee, Illinois 60118
    United States

    Active - Recruiting

  • Investigative Site US220

    West Dundee, Illinois 60118
    United States

    Site Not Available

  • Investigative Site US206

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Investigative Site US241

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Investigative Site US209

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Investigative Site US207

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Investigative Site US229

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Investigative Site US224

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Investigative Site US208

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Investigative Site US225

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Investigative Site US221

    Quincy, Massachusetts 02169
    United States

    Site Not Available

  • Investigative Site US213

    Detroit, Michigan 48084
    United States

    Site Not Available

  • Investigative Site US217

    Waterford, Michigan 48328
    United States

    Site Not Available

  • Investigative Site US212

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Investigative Site US239

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Investigative Site US230

    Hightstown, New Jersey 08520
    United States

    Site Not Available

  • Investigative Site US243

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Investigative Site US202

    New York, New York 10003
    United States

    Site Not Available

  • Investigative Site US210

    Rochester, New York 14642
    United States

    Site Not Available

  • Investigative Site US205

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • Investigative Site US215

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Investigative Site US203

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Investigative Site US232

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Investigative Site US235

    Arlington, Texas 76011
    United States

    Site Not Available

  • Investigative Site US218

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Investigative Site US238

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Investigative Site US234

    San Antonio, Texas 78213
    United States

    Site Not Available

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