A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

NCT06212999 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: INCB 54707-3122023-507204-31-00
• Study Type: interventional
• Target: 617
• Locations: 16 countries
• Sites: 158

Brief Summary

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 \[NCT05620823\] or INCB 54707-302 \[NCT05620836\]).

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Hidradenitis Suppurativa; Hidradenitis; Acne inversa; HS; Povorcitinib; Long-Term Extension (LTE); INCB054707

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)

  TEAE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.

  up to approximately 56 weeks

Secondary Outcomes (15)

• Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)

  up to approximately 56 weeks

• Proportion of participants with TEAEs leading to study drug discontinuation

  up to approximately 56 weeks

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

  up to approximately 56 weeks

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

  up to approximately 56 weeks

• Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)

  up to approximately 56 weeks

Study Arms (3)

Cohort A

EXPERIMENTAL

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Drug: Povorcitinib

Cohort B

EXPERIMENTAL

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Drug: Povorcitinib

Cohort C

EXPERIMENTAL

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Drug: Povorcitinib

Interventions

Povorcitinib DRUG

Oral; Tablet

Also known as: INCB054707

Cohort A; Cohort B; Cohort C

Eligibility Criteria

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

You may qualify if:

• Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
• Agreement to use contraception.
• Willing and able to comply with the study protocol and procedures.

You may not qualify if:

• Participation in the extension study could expose the participant to an undue safety risk.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (165)

Investigative Site US303

Phoenix, Arizona, 85006, United States

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Investigative Site US240

Scottsdale, Arizona, 85255, United States

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Investigative Site US307

Fort Smith, Arkansas, 72916, United States

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Investigative Site US214

Rogers, Arkansas, 72758, United States

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Investigative Site US315

Laguna Niguel, California, 92677, United States

Location

Investigative Site US223

Los Angeles, California, 90033, United States

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Investigative Site US222

Oakland, California, 94611, United States

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Investigative Site US226

San Diego, California, 92103, United States

Location

Investigative Site US309

Clearwater, Florida, 33614, United States

Location

Investigative Site US317

Hialeah, Florida, 33012-3618, United States

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Investigative Site US306

Hollywood, Florida, 33021, United States

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Investigative Site US320

Hollywood, Florida, 33021, United States

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Investigative Site US316

Maitland, Florida, 32751, United States

Location

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

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Investigative Site US321

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

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Investigative Site US200

Ocala, Florida, 34470, United States

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Investigative Site US228

Tampa, Florida, 33609, United States

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Investigative Site US201

Tampa, Florida, 33613, United States

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Investigative Site US311

Marietta, Georgia, 30060, United States

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Investigative Site US220

West Dundee, Illinois, 60118, United States

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Investigative Site US206

Indianapolis, Indiana, 46250, United States

Location

Investigative Site US337

Indianapolis, Indiana, 46250, United States

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Investigative Site US341

Bowling Green, Kentucky, 42104, United States

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Investigative Site US209

Louisville, Kentucky, 40241, United States

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Investigative Site US305

Baton Rouge, Louisiana, 70809, United States

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Investigative Site US207

Metairie, Louisiana, 70006, United States

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Investigative Site US229

New Orleans, Louisiana, 70115, United States

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Investigative Site US224

Baltimore, Maryland, 21287, United States

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Investigative Site US325

Marriottsville, Maryland, 21104, United States

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Investigative Site US225

Boston, Massachusetts, 02115, United States

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Investigative Site US304

Boston, Massachusetts, 02215, United States

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Investigative Site US310

Brighton, Massachusetts, 02135, United States

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Investigative Site US221

Quincy, Massachusetts, 02169, United States

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Investigative Site US213

Fort Gratiot, Michigan, 48059, United States

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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 US302

St Louis, Missouri, 63110, United States

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Investigative Site US318

Portsmouth, New Hampshire, 03801, United States

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Investigative Site US230

East Windsor, New Jersey, 08520, United States

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Investigative Site US324

Kew Gardens, New York, 11415, United States

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Investigative Site US202

New York, New York, 10028, United States

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Investigative Site US210

Rochester, New York, 14620, 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

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Investigative Site US339

Bexley, Ohio, 43209, United States

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Investigative Site US330

Boardman, Ohio, 44512, United States

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Investigative Site US314

Cincinnati, Ohio, 45219, United States

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Investigative Site US312

Cleveland, Ohio, 44106, United States

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Investigative Site US203

Gahanna, Ohio, 43230, United States

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Investigative Site US301

Portland, Oregon, 97201, United States

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Investigative Site US232

Murfreesboro, Tennessee, 37130, United States

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Investigative Site US235

Arlington, Texas, 76011, United States

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Investigative Site US218

Bellaire, Texas, 77401, United States

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Investigative Site US340

Bellaire, Texas, 77401, United States

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Investigative Site US238

Pflugerville, Texas, 78660, United States

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Investigative Site US300

Plano, Texas, 75025, United States

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Investigative Site US234

San Antonio, Texas, 78213, United States

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Investigative Site US313

Norfolk, Virginia, 23502, United States

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Investigative Site US308

Spokane, Washington, 99202, United States

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Investigative Site AU203

Charlestown, New South Wales, 02290, Australia

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Investigative Site AU205

Kogarah, New South Wales, 02217, Australia

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Investigative Site AU200

Liverpool, New South Wales, 02170, Australia

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Investigative Site AU206

Woolloongabba, Queensland, 04102, Australia

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Investigative Site AU207

Woolloongabba, Queensland, 04102, Australia

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Investigative Site AU201

Carlton, Victoria, 03053, Australia

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Investigative Site AU204

Melbourne, Victoria, 03002, Australia

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Investigative Site AT306

Inssbruck, 06020, Austria

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Investigative Site AT305

Vienna, 01090, Austria

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Investigative Site BE300

Brussels, 01070, Belgium

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Investigative Site BE301

Ghent, 09000, Belgium

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Investigative Site BE302

Liège, 04000, Belgium

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Investigative Site BG203

Sofia, 01407, Bulgaria

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Investigative Site BG202

Sofia, 01463, Bulgaria

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Investigative Site BG200

Sofia, 01510, Bulgaria

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Investigative Site BG204

Sofia, 01606, Bulgaria

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Investigative Site BG201

Stara Zagora, 06000, Bulgaria

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Investigative Site CA202

Calgary, Alberta, T3E 0B2, Canada

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Investigative Site CA204

Edmonton, Alberta, T6G 1C3, Canada

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Investigative Site CA200

Surrey, British Columbia, V3V 0C6, Canada

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Investigative Site CA301

Winnipeg, Manitoba, R3M 3Z4, Canada

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Investigative Site CA205

Fredericton, New Brunswick, E3B 1G9, Canada

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Investigative Site CA304

Barrie, Ontario, L4M 7G1, Canada

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Investigative Site CA308

Hamilton, Ontario, L8L 3C3, Canada

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Investigative Site CA303

London, Ontario, N6H 5L5, Canada

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Investigative Site CA207

Mississauga, Ontario, L4W 0C2, Canada

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Investigative Site CA302

Peterborough, Ontario, K9J 5K2, Canada

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Investigative Site CA208

Richmond Hill, Ontario, L4B 1L1, Canada

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Investigative Site CA307

Montreal, Quebec, H2X 2V1, 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 CZ301

Ostrava - Poruba, 708 52, Czechia

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Investigative Site CZ300

Prague, 150 06, Czechia

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Investigative Site DK200

Århus N, 08200, Denmark

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Investigative Site DK201

Roskilde, 04000, Denmark

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Investigative Site FR305

Bordeaux, 33000, France

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Investigative Site FR303

Brest, 29609, France

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Investigative Site FR205

Dijon, 21000, France

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Investigative Site FR307

Le Mans, 72037, France

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Investigative Site FR204

Lyon, 69437, France

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Investigative Site FR304

Marseille, 13385, France

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Investigative Site FR302

Nantes, 44093, France

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Investigative Site FR203

Nice, 06200, France

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Investigative Site FR300

Paris, 75010, France

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Investigative Site FR206

Reims, 51100, France

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Investigative Site FR202

Rouen, 76031, France

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Investigative Site FR301

Saint-Priest-en-Jarez, 42270, France

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Investigative Site FR306

Toulouse, 31059, France

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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 DE305

Darmstadt, 64283, Germany

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Investigative Site DE201

Dessau, 06847, Germany

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Investigative Site DE302

Dresden, 01307, Germany

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Investigative Site DE306

Düsseldorf, 40225, Germany

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Investigative Site DE207

Erlangen, 91054, Germany

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Investigative Site DE301

Frankfurt, 60590, Germany

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Investigative Site DE208

Göttingen, 37075, Germany

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Investigative Site DE303

Hamburg, 20246, Germany

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Investigative Site DE300

Hanover, 30159, 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 DE307

Memmingen, 87700, Germany

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Investigative Site DE206

Merzig, 66663, Germany

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Investigative Site GR300

Athens, 12462, Greece

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Investigative Site GR303

Athens, 16121, Greece

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Investigative Site GR302

Thessaloniki, 56403, Greece

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Investigative Site IT200

Ancona, 60126, Italy

Location

Investigative Site IT207

Catania, 95123, Italy

Location

Investigative Site IT202

Milan, 20122, Italy

Location

Investigative Site IT206

Pisa, 56126, Italy

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Investigative Site IT205

Roma, 00136, Italy

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Investigative Site IT201

Rozzano, 20089, Italy

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Investigative Site JP301

Ginowan-shi, 901-2725, Japan

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Investigative Site JP304

Itabashi-ku, 173-8610, Japan

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Investigative Site JP305

Kurume-shi, 830-0011, Japan

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Investigative Site JP300

Kyoto, 602-8566, Japan

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Investigative Site JP303

Niigata, 951-8520, Japan

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Investigative Site JP308

Sapporo, 060-8648, Japan

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Investigative Site JP302

Sendai, 980-8574, Japan

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Investigative Site JP309

Shinjuku-ku, 160-0023, Japan

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Investigative Site NL302

Breda, 4818 CK, Netherlands

Location

Investigative Site NL303

Groningen, 9713 GZ, Netherlands

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Investigative Site NL301

Rotterdam, 3015 GD, Netherlands

Location

Investigative Site PL203

Lublin, 20573, Poland

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Investigative Site PL304

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Investigative Site PL200

Rzeszów, 35-055, Poland

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Investigative Site PL201

Warsaw, 02-507, Poland

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Investigative Site PL202

Warsaw, 02-962, Poland

Location

Investigative Site PL301

Wroclaw, 50-566, Poland

Location

Investigative Site PL302

Wroclaw, 51-503, Poland

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Investigative Site ES203

Alicante, 03010, Spain

Location

Investigative Site ES302

Badalona, 08916, Spain

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Investigative Site ES303

Barcelona, 08003, Spain

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Investigative Site ES301

Granada, 18014, Spain

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Investigative Site ES202

Las Palmas de Gran Canaria, 35010, Spain

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Investigative Site ES201

Madrid, 28009, Spain

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Investigative Site ES205

Madrid, 28040, Spain

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Investigative Site ES305

Madrid, 28041, Spain

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Investigative Site ES200

Manises, 46940, Spain

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Investigative Site ES300

Pontevedra, 36001, Spain

Location

Investigative Site ES304

Santiago de Compostela, 15706, Spain

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Investigative Site GB202

Birmingham, B15 2TH, United Kingdom

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Investigative Site GB200

Dudley, DY1 2HQ, United Kingdom

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Investigative Site GB203

Salford, M6 8HD, United Kingdom

Location

Related Links

• A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS LTE)

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 Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cohort C is open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

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

BU (5); AU (2); GR (3); DK (2); ES (11); FR (13); IT (6); BE (3); CA (14); NL (3); PL (7); GB (3); DE (15); US (61); JP (8); CZ (2)