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

NCT05620823 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: INCB 54707-3012022-501752-29-00
• Study Type: interventional
• Target: 608
• Locations: 12 countries
• Sites: 104

Brief 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.

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Hidradenitis Suppurativa; Hidradenitis; Acne inversa; HS; INCB054707; Povorcitinib

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)

  HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

  Week 12

Secondary Outcomes (22)

• Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

  Week 12

• Proportion of participants with flare

  12 weeks

• Proportion of participants with a ≥ 3-point decrease in Skin Pain Numeric Rating Scale (NRS) score among participants with baseline Skin Pain NRS score ≥ 3.

  Week 12

• Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.

  Week 12

• Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score

  Week 12

Study Arms (3)

Povorcitinib Dose A

EXPERIMENTAL

Participants will receive Povorcitinib Dose A for 54 weeks.

Drug: Povorcitinib

Povorcitinib Dose B

EXPERIMENTAL

Participants will receive Povorcitinib Dose B for 54 weeks.

Drug: Povorcitinib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Povorcitinib DRUG

Oral; Tablet

Also known as: INCB054707

Povorcitinib Dose A; Povorcitinib Dose B

Placebo DRUG

Oral; Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (104)

Investigative Site US303

Phoenix, Arizona, 85006, United States

Location

Investigative Site US335

Arkansas City, Arkansas, 72758, United States

Location

Investigative Site US307

Fort Smith, Arkansas, 72916, United States

Location

Investigative Site US315

Laguna Niguel, California, 92677, United States

Location

Investigative Site US326

Los Angeles, California, 90045, United States

Location

Investigative Site US323

San Francisco, California, 94118, United States

Location

Investigative Site US306

Boca Raton, Florida, 33486, United States

Location

Investigative Site US320

Boca Raton, Florida, 33486, United States

Location

Investigative Site US317

Hialeah, Florida, 33012-3618, United States

Location

Investigative Site US338

Margate, Florida, 33063, United States

Location

Investigative Site US321

North Miami Beach, Florida, 33162-4708, United States

Location

Investigative Site US316

Orlando, Florida, 32819, United States

Location

Investigative Site US328

Tampa, Florida, 33612, United States

Location

Investigative Site US336

Tampa, Florida, 33613, United States

Location

Investigative Site US311

Marietta, Georgia, 30060-1047, United States

Location

Investigative Site US327

Chicago, Illinois, 60612, United States

Location

Investigative Site US319

Skokie, Illinois, 60077, United States

Location

Investigative Site US337

Indianapolis, Indiana, 46250, United States

Location

Investigative Site US341

Bowling Green, Kentucky, 42103, United States

Location

Investigative Site US334

Metairie, Louisiana, 70006, United States

Location

Investigative Site US333

Baltimore, Maryland, 21287, United States

Location

Investigative Site US325

Columbia, Maryland, 21045, United States

Location

Investigative Site US318

Beverly, Massachusetts, 01915, United States

Location

Investigative Site US304

Boston, Massachusetts, 02215, United States

Location

Investigative Site US310

Brighton, Massachusetts, 02135, United States

Location

Investigative Site US302

St Louis, Missouri, 63110, United States

Location

Investigative Site US331

Albuquerque, New Mexico, 87102, United States

Location

Investigative Site US324

Kew Gardens, New York, 11415, United States

Location

Investigative Site US339

Bexley, Ohio, 43209, United States

Location

Investigative Site US330

Boardman, Ohio, 44512, United States

Location

Investigative Site US314

Cincinnati, Ohio, 45219, United States

Location

Investigative Site US312

Cleveland, Ohio, 44106, United States

Location

Investigative Site US301

Portland, Oregon, 97223, United States

Location

Investigative Site US340

Bellaire, Texas, 77401, United States

Location

Investigative Site US300

Plano, Texas, 75025, United States

Location

Investigative Site US313

Norfolk, Virginia, 23502, United States

Location

Investigative Site US308

Spokane, Washington, 99202, United States

Location

Investigative Site AT304

Graz, 08036, Austria

Location

Investigative Site 00A

Innsbruck, 06020, Austria

Location

Investigative Site AT306

Innsbruck, 06020, Austria

Location

Investigative Site AT302

Linz, 04020, Austria

Location

Investigative Site AT305

Vienna, 01090, Austria

Location

Investigative Site AT301

Vienna, 01100, Austria

Location

Investigative Site AT300

Vienna, 01130, Austria

Location

Investigative Site BE300

Brussels, 01070, Belgium

Location

Investigative Site BE304

Brussels, 01200, Belgium

Location

Investigative Site BE301

Ghent, 09000, Belgium

Location

Investigative Site BE306

Ghent, 09000, Belgium

Location

Investigative Site BE305

Leuven, 03000, Belgium

Location

Investigative Site BE302

Liège, 04000, Belgium

Location

Investigative Site BE303

Namur, 05000, Belgium

Location

Investigative Site CA301

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Investigative Site CA304

Barrie, Ontario, L4M 1G7, Canada

Location

Investigative Site CA308

Hamilton, Ontario, L8L 3C3, Canada

Location

Investigative Site CA303

London, Ontario, N6H 5L5, Canada

Location

Investigative Site CA302

Peterborough, Ontario, K9J 5K2, Canada

Location

Investigative Site CA306

Laval, Quebec, H7N 6L2, Canada

Location

Investigative Site CA307

Montreal, Quebec, H2K 4L5, Canada

Location

Investigative Site CA309

Québec, Quebec, G1V 4T3, Canada

Location

Investigative Site CZ301

Ostrava - Poruba, 708 52, Czechia

Location

Investigative Site CZ300

Prague, 150 06, Czechia

Location

Investigative Site FR305

Bordeaux, 33000, France

Location

Investigative Site FR303

Brest, 29609, France

Location

Investigative Site FR307

Le Mans, 72037, France

Location

Investigative Site FR304

Marseille, 13385, France

Location

Investigative Site FR302

Nantes, 44093, France

Location

Investigative Site FR300

Paris, 75010, France

Location

Investigative Site FR301

Saint-Priest-en-Jarez, 42270, France

Location

Investigative Site FR306

Toulouse, 31059, France

Location

Investigative Site DE305

Darmstadt, 64283, Germany

Location

Investigative Site DE302

Dresden, 01307, Germany

Location

Investigative Site DE306

Düsseldorf, 40225, Germany

Location

Investigative Site DE301

Frankfurt am Main, 60590, Germany

Location

Investigative Site DE303

Hamburg, 20246, Germany

Location

Investigative Site DE300

Hanover, 30519, Germany

Location

Investigative Site DE304

Langenau, 89129, Germany

Location

Investigative Site DE307

Memmingen, 87700, Germany

Location

Investigative Site GR300

Athens, 12462, Greece

Location

Investigative Site GR303

Athens, 16121, Greece

Location

Investigative Site GR301

Thessaloniki, 54643, Greece

Location

Investigative Site GR302

Thessaloniki, 56403, Greece

Location

Investigative Site JP304

Itabashi-ku, 173-8610, Japan

Location

Investigative Site JP305

Kurume-shi, 830-0011, Japan

Location

Investigative Site JP300

Kyoto, 602-8566, Japan

Location

Investigative Site JP301

Nakagami-gun, 903-0215, Japan

Location

Investigative Site JP303

Niigata, 951-8520, Japan

Location

Investigative Site JP307

Nishinomiya-shi, 663-8186, Japan

Location

Investigative Site JP308

Sapporo, 060-8648, Japan

Location

Investigative Site JP302

Sendai, 980-8574, Japan

Location

Investigative Site JP309

Shinjuku-ku, 160-0023, Japan

Location

Investigative Site JP306

Tsukuba, 305-8576, Japan

Location

Investigative Site NL302

Breda, 4818 CK, Netherlands

Location

Investigative Site NL303

Groningen, 9713 GZ, Netherlands

Location

Investigative Site NL301

Rotterdam, 3015 GD, Netherlands

Location

Investigative Site PL304

Ostrowiec, 27-400, Poland

Location

Investigative Site PL303

Poznan, 60-529, Poland

Location

Investigative Site PL301

Wroclaw, 50-566, Poland

Location

Investigative Site PL302

Wroclaw, 51-318, Poland

Location

Investigative Site ES302

Badalona, 08916, Spain

Location

Investigative Site ES303

Barcelona, 08003, Spain

Location

Investigative Site ES301

Granada, 18014, Spain

Location

Investigative Site ES305

Madrid, 28041, Spain

Location

Investigative Site ES300

Pontevedra, 36001, Spain

Location

Investigative Site ES304

Santiago de Compostela, 15706, Spain

Location

Related Links

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

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Sweat Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: December 19, 2022
• Primary Completion: February 3, 2025
• Study Completion: December 23, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

BE (7); AU (7); GR (4); JP (10); NL (3); PL (4); CZ (2); DE (8); ES (6); US (37); CA (8); FR (8)