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

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

Phase

3

Condition

Hidradenitis Suppurativa

Scalp Disorders

Acne Inversa

Treatment

Povorcitinib

Placebo

Clinical Study ID

NCT05620823
INCB 54707-301
  • 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:

  • Diagnosis of moderate to severe HS for at least 3 months prior to the screeningvisit.

  • Total abscess and inflammatory nodule count of at least 5 at both the screening andbaseline visits

  • HS lesions in at least 2 distinct anatomical areas (examples include but are notlimited to left and right axilla or left and right inguinocrural fold), 1 of whichmust be at least Hurley Stage II or Hurley Stage III, at both the screening andbaseline visits

  • Documented history of inadequate response to at least a 3-month course of at least 1conventional systemic therapy (oral antibiotic or biologic drug) for HS (ordemonstrated intolerance to, or have a contraindication to, a conventional systemictherapy for treatment of their HS).

  • Agreement to NOT use topical and systemic antibiotics for treatment of HS during theplacebo-controlled period.

  • Agreement to NOT use a diluted bleach bath or topical antiseptic washes containingchlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesionsduring the placebo-controlled period. Note: Over-the-counter soap and water isallowed.

  • Agreement to use contraception

  • Willing and able to comply with the study protocol and procedures.

  • Further inclusion criteria apply.

Exclusion

Exclusion Criteria:

  • Presence of > 20 draining tunnels (fistulas) at either the screening or baselinevisit.

  • 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 theinvestigator.

  • Laboratory values outside of the protocol-defined ranges.

  • Further exclusion criteria apply.

Study Design

Total Participants: 608
Treatment Group(s): 2
Primary Treatment: Povorcitinib
Phase: 3
Study Start date:
December 19, 2022
Estimated Completion Date:
January 30, 2026

Connect with a study center

  • Investigative Site AT304

    Graz, 08036
    Austria

    Site Not Available

  • Investigative Site 00A

    Innsbruck, 06020
    Austria

    Site Not Available

  • Investigative Site AT306

    Innsbruck, 06020
    Austria

    Site Not Available

  • Investigative Site AT302

    Linz, 04020
    Austria

    Site Not Available

  • Investigative Site AT303

    Vienna, 01030
    Austria

    Site Not Available

  • Investigative Site AT305

    Vienna, 01090
    Austria

    Site Not Available

  • Investigative Site AT300

    Wien, 01130
    Austria

    Site Not Available

  • Investigative Site AT301

    Wien, 01100
    Austria

    Site Not Available

  • Investigative Site AT305

    Wien, 01090
    Austria

    Site Not Available

  • Investigative Site BE304

    Brussels, 01200
    Belgium

    Site Not Available

  • Investigative Site BE300

    Bruxelles, 01070
    Belgium

    Site Not Available

  • Investigative Site BE301

    Gent, 09000
    Belgium

    Active - Recruiting

  • Investigative Site BE306

    Gent, 09000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 09000
    Belgium

    Active - Recruiting

  • Investigative Site BE301

    Ghent, 09000
    Belgium

    Site Not Available

  • Investigative Site BE305

    Leuven, 03000
    Belgium

    Site Not Available

  • Investigative Site BE302

    Liege, 04000
    Belgium

    Site Not Available

  • Investigative Site BE303

    Namur, 05000
    Belgium

    Site Not Available

  • Investigative Site CA301

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Investigative Site CA304

    Barrie, Ontario L4M 1G7
    Canada

    Site Not Available

  • Investigative Site CA308

    Hamilton, Ontario L8L 3C3
    Canada

    Site Not Available

  • Investigative Site CA303

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Investigative Site CA305

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Investigative Site CA302

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Investigative Site CA306

    Laval, Quebec H7N 6L2
    Canada

    Site Not Available

  • Investigative Site CA307

    Montreal, Quebec H2K 4L5
    Canada

    Site Not Available

  • Investigative Site CA309

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • Investigative Site CZ301

    Ostrava - Poruba, 708 52
    Czechia

    Site Not Available

  • Investigative Site CZ300

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Bordeaux Chu Hopital Saint - Andre

    Bordeaux, 33000
    France

    Active - Recruiting

  • Investigative Site FR305

    Bordeaux, 33000
    France

    Site Not Available

  • Investigative Site FR303

    Brest Cedex 2, 29609
    France

    Site Not Available

  • Centre Hospitalier Du Mans

    Le Mans Cedex, 72037
    France

    Active - Recruiting

  • Investigative Site FR307

    Le Mans Cedex, 72037
    France

    Site Not Available

  • Investigative Site FR304

    Marseille, 13385
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes Cedex 1, 44093
    France

    Active - Recruiting

  • Investigative Site FR302

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • Investigative Site FR300

    Paris, 75010
    France

    Site Not Available

  • Investigative Site FR301

    Saint Etienne Cedex 2, 42055
    France

    Site Not Available

  • Investigative Site FR301

    Saint Priest En Jarez, 42270
    France

    Site Not Available

  • University Hospital of Saint Etienne

    Saint Priest En Jarez, 42270
    France

    Active - Recruiting

  • Investigative Site FR306

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Investigative Site DE305

    Darmstadt, 64283
    Germany

    Site Not Available

  • Investigative Site DE302

    Dresden, 01307
    Germany

    Site Not Available

  • Investigative Site DE306

    Duesseldorf, 40225
    Germany

    Site Not Available

  • Investigative Site DE301

    Frankfurt, 60590
    Germany

    Site Not Available

  • Investigative Site DE301

    Frankfurt Am Main, 60590
    Germany

    Site Not Available

  • Investigative Site DE303

    Hamburg, 20246
    Germany

    Site Not Available

  • Investigative Site DE300

    Hannover, 30519
    Germany

    Site Not Available

  • Investigative Site DE305

    Hessen, 64297
    Germany

    Site Not Available

  • Investigative Site DE304

    Langenau, 89129
    Germany

    Site Not Available

  • Investigative Site DE307

    Memmingen, 87700
    Germany

    Site Not Available

  • Investigative Site GR300

    Athens, 12462
    Greece

    Site Not Available

  • Investigative Site GR303

    Athens, 16121
    Greece

    Site Not Available

  • University Hospital of West Attica - Attikon

    Athens, 12462
    Greece

    Active - Recruiting

  • Investigative Site GR301

    Thessaloniki, 54643
    Greece

    Site Not Available

  • Investigative Site GR302

    Thessaloniki, 56403
    Greece

    Site Not Available

  • Investigative Site JP304

    Itabashi-ku, 173-8610
    Japan

    Site Not Available

  • Investigative Site JP305

    Kurume-shi, 830-0011
    Japan

    Site Not Available

  • Investigative Site JP300

    Kyoto-shi, 602-8566
    Japan

    Site Not Available

  • Investigative Site JP301

    Nakagami-gun, 903-0215
    Japan

    Site Not Available

  • Investigative Site JP303

    Niigata-shi, 951-8520
    Japan

    Site Not Available

  • Investigative Site JP307

    Nishinomiya-shi, 663-8186
    Japan

    Site Not Available

  • Investigative Site JP308

    Sapporo-shi, 060-8648
    Japan

    Site Not Available

  • Investigative Site JP302

    Sendai-shi, 980-8574
    Japan

    Site Not Available

  • Investigative Site JP309

    Shinjuku-ku, 160-0023
    Japan

    Site Not Available

  • Investigative Site JP306

    Tsukuba-shi, 305-8576
    Japan

    Site Not Available

  • Investigative Site NL302

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • Investigative Site NL303

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Investigative Site NL301

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Investigative Site PL304

    Ostrowiec, 27-400
    Poland

    Site Not Available

  • Investigative Site PL303

    Poznan, 60-529
    Poland

    Site Not Available

  • Centrum Medyczne Matusiak

    Wroclaw, 50-566
    Poland

    Active - Recruiting

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-318
    Poland

    Active - Recruiting

  • Investigative Site PL301

    Wroclaw, 50-566
    Poland

    Site Not Available

  • Investigative Site PL302

    Wroclaw, 51-318
    Poland

    Site Not Available

  • Investigative Site ES302

    Badalona, 08916
    Spain

    Site Not Available

  • Hospital Del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Investigative Site ES303

    Barcelona, 08003
    Spain

    Site Not Available

  • Investigative Site ES301

    Granada, 18014
    Spain

    Site Not Available

  • Investigative Site ES305

    Madrid, 28041
    Spain

    Site Not Available

  • Investigative Site ES300

    Pontevedra, 36001
    Spain

    Site Not Available

  • Investigative Site ES304

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Investigative Site US303

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Investigative Site US335

    Arkansas, Arkansas 72758
    United States

    Site Not Available

  • Investigative Site US307

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Investigative Site US315

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • Investigative Site US326

    Los Angeles, California 90045
    United States

    Site Not Available

  • Investigative Site US323

    San Francisco, California 94118
    United States

    Site Not Available

  • Investigative Site US306

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Investigative Site US320

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Investigative Site US317

    Hialeah, Florida 33012-3618
    United States

    Site Not Available

  • Investigative Site US338

    Margate, Florida 33063
    United States

    Site Not Available

  • Investigative Site US321

    North Miami Beach, Florida 33162-4708
    United States

    Site Not Available

  • Investigative Site US316

    Orlando, Florida 32819
    United States

    Site Not Available

  • Investigative Site US328

    Tampa, Florida 33612
    United States

    Site Not Available

  • Investigative Site US336

    Tampa, Florida 33613
    United States

    Site Not Available

  • Investigative Site US311

    Marietta, Georgia 30060-1047
    United States

    Site Not Available

  • Investigative Site US327

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Investigative Site US319

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Investigative Site US337

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Investigative Site US332

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Investigative Site US341

    Bowling Green, Kentucky 42103
    United States

    Site Not Available

  • Investigative Site US334

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Investigative Site US333

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Investigative Site US325

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Investigative Site US318

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Investigative Site US304

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Investigative Site US310

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Investigative Site US322

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Investigative Site US302

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Investigative Site US331

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Investigative Site US324

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Investigative Site US339

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Investigative Site US330

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Investigative Site US314

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Investigative Site US312

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Investigative Site US301

    Portland, Oregon 97223
    United States

    Site Not Available

  • Investigative Site US340

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Investigative Site US300

    Plano, Texas 75025
    United States

    Site Not Available

  • Investigative Site US313

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Investigative Site US308

    Spokane, Washington 99202
    United States

    Site Not Available

  • Investigative Site US329

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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