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

NCT ID: NCT05620823

Last Updated: 2026-02-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

608 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2025-12-23

Brief Summary

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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

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Conditions

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Hidradenitis Suppurativa (HS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or placebo once a day (QD); participants who complete the placebo controlled (PC) 12-week period may continue to a 42-week extension(EXT) period with Povorcitinib (Dose A or Dose B) QD.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Povorcitinib Dose A

Participants will receive Povorcitinib Dose A for 54 weeks.

Group Type EXPERIMENTAL

Povorcitinib

Intervention Type DRUG

Oral; Tablet

Povorcitinib Dose B

Participants will receive Povorcitinib Dose B for 54 weeks.

Group Type EXPERIMENTAL

Povorcitinib

Intervention Type DRUG

Oral; Tablet

Placebo

Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral; Tablet

Interventions

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Povorcitinib

Oral; Tablet

Intervention Type DRUG

Placebo

Oral; Tablet

Intervention Type DRUG

Other Intervention Names

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INCB054707

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigative Site US303

Phoenix, Arizona, United States

Site Status

Investigative Site US335

Arkansas City, Arkansas, United States

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Investigative Site US307

Fort Smith, Arkansas, United States

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Investigative Site US315

Laguna Niguel, California, United States

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Investigative Site US326

Los Angeles, California, United States

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Investigative Site US323

San Francisco, California, United States

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Investigative Site US306

Boca Raton, Florida, United States

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Investigative Site US320

Boca Raton, Florida, United States

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Investigative Site US317

Hialeah, Florida, United States

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Investigative Site US338

Margate, Florida, United States

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Investigative Site US321

North Miami Beach, Florida, United States

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Investigative Site US316

Orlando, Florida, United States

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Investigative Site US328

Tampa, Florida, United States

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Investigative Site US336

Tampa, Florida, United States

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Investigative Site US311

Marietta, Georgia, United States

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Investigative Site US327

Chicago, Illinois, United States

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Investigative Site US319

Skokie, Illinois, United States

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Investigative Site US337

Indianapolis, Indiana, United States

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Investigative Site US341

Bowling Green, Kentucky, United States

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Investigative Site US334

Metairie, Louisiana, United States

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Investigative Site US333

Baltimore, Maryland, United States

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Investigative Site US325

Columbia, Maryland, United States

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Investigative Site US318

Beverly, Massachusetts, United States

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Investigative Site US304

Boston, Massachusetts, United States

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Investigative Site US310

Brighton, Massachusetts, United States

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Investigative Site US302

St Louis, Missouri, United States

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Investigative Site US331

Albuquerque, New Mexico, United States

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Investigative Site US324

Kew Gardens, New York, United States

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Investigative Site US339

Bexley, Ohio, United States

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Investigative Site US330

Boardman, Ohio, United States

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Investigative Site US314

Cincinnati, Ohio, United States

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Investigative Site US312

Cleveland, Ohio, United States

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Investigative Site US301

Portland, Oregon, United States

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Investigative Site US340

Bellaire, Texas, United States

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Investigative Site US300

Plano, Texas, United States

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Investigative Site US313

Norfolk, Virginia, United States

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Investigative Site US308

Spokane, Washington, United States

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Investigative Site AT304

Graz, , Austria

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Investigative Site 00A

Innsbruck, , Austria

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Investigative Site AT306

Innsbruck, , Austria

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Investigative Site AT302

Linz, , Austria

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Investigative Site AT305

Vienna, , Austria

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Investigative Site AT301

Vienna, , Austria

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Investigative Site AT300

Vienna, , Austria

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Investigative Site BE300

Brussels, , Belgium

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Investigative Site BE304

Brussels, , Belgium

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Investigative Site BE301

Ghent, , Belgium

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Investigative Site BE306

Ghent, , Belgium

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Investigative Site BE305

Leuven, , Belgium

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Investigative Site BE302

Liège, , Belgium

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Investigative Site BE303

Namur, , Belgium

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Investigative Site CA301

Winnipeg, Manitoba, Canada

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Investigative Site CA304

Barrie, Ontario, Canada

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Investigative Site CA308

Hamilton, Ontario, Canada

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Investigative Site CA303

London, Ontario, Canada

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Investigative Site CA302

Peterborough, Ontario, Canada

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Investigative Site CA306

Laval, Quebec, Canada

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Investigative Site CA307

Montreal, Quebec, Canada

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Investigative Site CA309

Québec, Quebec, Canada

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Investigative Site CZ301

Ostrava - Poruba, , Czechia

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Investigative Site CZ300

Prague, , Czechia

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Investigative Site FR305

Bordeaux, , France

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Investigative Site FR303

Brest, , France

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Investigative Site FR307

Le Mans, , France

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Investigative Site FR304

Marseille, , France

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Investigative Site FR302

Nantes, , France

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Investigative Site FR300

Paris, , France

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Investigative Site FR301

Saint-Priest-en-Jarez, , France

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Investigative Site FR306

Toulouse, , France

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Investigative Site DE305

Darmstadt, , Germany

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Investigative Site DE302

Dresden, , Germany

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Investigative Site DE306

Düsseldorf, , Germany

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Investigative Site DE301

Frankfurt am Main, , Germany

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Investigative Site DE303

Hamburg, , Germany

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Investigative Site DE300

Hanover, , Germany

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Investigative Site DE304

Langenau, , Germany

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Investigative Site DE307

Memmingen, , Germany

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Investigative Site GR300

Athens, , Greece

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Investigative Site GR303

Athens, , Greece

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Investigative Site GR301

Thessaloniki, , Greece

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Investigative Site GR302

Thessaloniki, , Greece

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Investigative Site JP304

Itabashi-ku, , Japan

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Investigative Site JP305

Kurume-shi, , Japan

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Investigative Site JP300

Kyoto, , Japan

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Investigative Site JP301

Nakagami-gun, , Japan

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Investigative Site JP303

Niigata, , Japan

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Investigative Site JP307

Nishinomiya-shi, , Japan

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Investigative Site JP308

Sapporo, , Japan

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Investigative Site JP302

Sendai, , Japan

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Investigative Site JP309

Shinjuku-ku, , Japan

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Investigative Site JP306

Tsukuba, , Japan

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Investigative Site NL302

Breda, , Netherlands

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Investigative Site NL303

Groningen, , Netherlands

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Investigative Site NL301

Rotterdam, , Netherlands

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Investigative Site PL304

Ostrowiec, , Poland

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Investigative Site PL303

Poznan, , Poland

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Investigative Site PL301

Wroclaw, , Poland

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Investigative Site PL302

Wroclaw, , Poland

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Investigative Site ES302

Badalona, , Spain

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Investigative Site ES303

Barcelona, , Spain

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Investigative Site ES301

Granada, , Spain

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Investigative Site ES305

Madrid, , Spain

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Investigative Site ES300

Pontevedra, , Spain

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Investigative Site ES304

Santiago de Compostela, , Spain

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Countries

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United States Austria Belgium Canada Czechia France Germany Greece Japan Netherlands Poland Spain

Related Links

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https://incyteclinicaltrials.com/studies/incb-54707-301

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

Other Identifiers

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2022-501752-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

INCB 54707-301

Identifier Type: -

Identifier Source: org_study_id

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