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

NCT05620836 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: INCB 54707-3022022-501753-36-00
• Study Type: interventional
• Target: 619
• Locations: 11 countries
• Sites: 101

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; HS; INCB054707; Povorcitinib; Acne inversa; Hidradenitis

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 at Week 12 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:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (101)

Investigative Site US240

Scottsdale, Arizona, 85255, United States

Location

Investigative Site US237

Scottsdale, Arizona, 85259, United States

Location

Investigative Site US214

Arkansas City, Arkansas, 72758, United States

Location

Investigative Site US242

Fayetteville, Arkansas, 72703, United States

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Investigative Site US223

Los Angeles, California, 90033, United States

Location

Investigative Site US226

San Diego, California, 92103, United States

Location

Investigative Site US222

San Francisco, California, 94118, United States

Location

Investigative Site US233

Washington D.C., District of Columbia, 20060, United States

Location

Investigative Site US228

Brandon, Florida, 33511, United States

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Investigative Site US227

Margate, Florida, 33063, United States

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Investigative Site US204

Miami, Florida, 33125, United States

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Investigative Site US236

Miami, Florida, 33173, United States

Location

Investigative Site US200

Ocala, Florida, 34470, United States

Location

Investigative Site US201

Tampa, Florida, 33613, United States

Location

Investigative Site US220

West Dundee, Illinois, 60118, United States

Location

Investigative Site US206

Indianapolis, Indiana, 46250, United States

Location

Investigative Site US241

Iowa City, Iowa, 52242, United States

Location

Investigative Site US209

Louisville, Kentucky, 40241, United States

Location

Investigative Site US207

Metairie, Louisiana, 70006, United States

Location

Investigative Site US229

New Orleans, Louisiana, 70115, United States

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Investigative Site US224

Baltimore, Maryland, 21224, United States

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Investigative Site US208

Beverly, Massachusetts, 01915, United States

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Investigative Site US221

Quincy, Massachusetts, 02169, United States

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Investigative Site US213

Detroit, Michigan, 48084, United States

Location

Investigative Site US217

Waterford, Michigan, 48328, United States

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Investigative Site US212

Minneapolis, Minnesota, 55455, United States

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Investigative Site US239

Omaha, Nebraska, 68144, United States

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Investigative Site US230

Hightstown, New Jersey, 08520, United States

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Investigative Site US202

New York, New York, 10003, United States

Location

Investigative Site US210

Rochester, New York, 14642, United States

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Investigative Site US205

Chapel Hill, North Carolina, 27516, United States

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Investigative Site US215

Bexley, Ohio, 43209, United States

Location

Investigative Site US203

Columbus, Ohio, 43210, United States

Location

Investigative Site US232

Murfreesboro, Tennessee, 37130, United States

Location

Investigative Site US235

Arlington, Texas, 76011, United States

Location

Investigative Site US218

Bellaire, Texas, 77401, United States

Location

Investigative Site US238

Pflugerville, Texas, 78660, United States

Location

Investigative Site US234

San Antonio, Texas, 78213, United States

Location

Investigative Site AU205

Kogarah, New South Wales, 02217, Australia

Location

Investigative Site AU203

Kotara, New South Wales, 02289, Australia

Location

Investigative Site AU200

Liverpool, New South Wales, 02170, Australia

Location

Investigative Site AU202

Benowa, Queensland, 04217, Australia

Location

Investigative Site AU206

Woolloongabba, Queensland, 04102, Australia

Location

Investigative Site AU207

Woolloongabba, Queensland, 04102, Australia

Location

Investigative Site AU201

Carlton, Victoria, 03053, Australia

Location

Investigative Site AU204

Melbourne, Victoria, 03002, Australia

Location

Investigative Site BG203

Sofia, 01407, Bulgaria

Location

Investigative Site BG202

Sofia, 01463, Bulgaria

Location

Investigative Site BG200

Sofia, 01510, Bulgaria

Location

Investigative Site BG204

Sofia, 01606, Bulgaria

Location

Investigative Site BG201

Stara Zagora, 06000, Bulgaria

Location

Investigative Site CA202

Calgary, Alberta, T3E 0B2, Canada

Location

Investigative Site CA204

Edmonton, Alberta, T6G 1C3, Canada

Location

Investigative Site CA200

Surrey, British Columbia, V3V 0C6, Canada

Location

Investigative Site CA205

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Investigative Site CA207

Mississauga, Ontario, L4W 0C2, Canada

Location

Investigative Site CA208

Richmond Hill, Ontario, L4C 9M7, Canada

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Investigative Site CA206

Saint-Jérôme, Quebec, J7Z 7E2, Canada

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Investigative Site CA203

St. John's, A1A 4Y3, Canada

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Investigative Site DK200

Århus N, 08200, Denmark

Location

Investigative Site DK201

Roskilde, 04000, Denmark

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Investigative Site FR200

Antony, 92160, France

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Investigative Site FR205

Dijon, 21000, France

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Investigative Site FR204

Lyon, 69003, France

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Investigative Site FR203

Nice, 06200, France

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Investigative Site FR206

Reims, 51100, France

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Investigative Site FR202

Rouen, 76031, France

Location

Investigative Site FR201

Toulon, 83000, France

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Investigative Site US225

Frankfurt am Main, MA, 60590, Germany

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Investigative Site DE202

Berlin, 10117, Germany

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Investigative Site DE203

Bochum, 44791, Germany

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Investigative Site DE201

Dessau, 06847, Germany

Location

Investigative Site DE207

Erlangen, 91054, Germany

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Investigative Site DE208

Göttingen, 37075, Germany

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Investigative Site DE205

Heidelberg, 69120, Germany

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Investigative Site DE200

Kiel, 24105, Germany

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Investigative Site DE204

Lübeck, 23538, Germany

Location

Investigative Site DE206

Mainz, 55131, Germany

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Investigative Site IT200

Ancona, 60126, Italy

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Investigative Site IT204

Brescia, 25124, Italy

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Investigative Site IT207

Catania, 95123, Italy

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Investigative Site IT202

Milan, 20122, Italy

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Investigative Site IT203

Naples, 80131, Italy

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Investigative Site IT206

Pisa, 56126, Italy

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Investigative Site IT205

Roma, 00168, Italy

Location

Investigative Site IT201

Rozzano, 20089, Italy

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Investigative Site PL203

Lublin, 20573, Poland

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Investigative Site PL200

Rzeszów, 35-055, Poland

Location

Investigative Site PL201

Warsaw, 02-507, Poland

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Investigative Site PL202

Warsaw, 02-962, Poland

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Investigative Site ES203

Alicante, 03010, Spain

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Investigative Site ES202

Las Palmas de Gran Canaria, 35019, Spain

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Investigative Site ES204

Madrid, 28005, Spain

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Investigative Site ES201

Madrid, 28007, Spain

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Investigative Site ES205

Madrid, 28040, Spain

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Investigative Site ES200

Manises, 46940, Spain

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Investigative Site GB202

Birmingham, B15 2GW, United Kingdom

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Investigative Site GB200

Dudley, DY1 2HQ, United Kingdom

Location

Investigative Site GB201

Leeds, LS1 3EX, United Kingdom

Location

Investigative Site GB204

London, SE1 7EH, United Kingdom

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Investigative Site GB203

Salford, M6 8HD, United Kingdom

Location

Related Links

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

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: February 22, 2023
• Primary Completion: January 7, 2025
• Study Completion: November 21, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

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

PL (4); GB (5); BU (5); FR (7); US (38); DE (10); CA (8); DK (2); AU (8); ES (6); IT (8)