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NCT07228390PHASE2Recruiting

A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.

Pfizer

Start Date

11/13/2025

Completion Date

4/2/2027

Summary

The purpose of this study is to learn about the safety and effects of the study medicine (called Ritlecitinib) for the possible treatment of hidradenitis suppurativa (HS). HS is a disease causing long lasting painful red skin lumps. This study is seeking participants who: * have moderate or severe HS * have previously received antibiotics for HS that did not help, or could not tolerate antibiotics Participants will be randomly (like a flip of coin) assigned to receive either the study medicine or a placebo (a pill that looks like the study medicine but does not contain any medicine). The study medicine or placebo will be taken by mouth once daily at home. For the first part of the study, participants will receive a loading (starting) dose. For the next part of the study, participants will receive a maintenance (ongoing) dose. Participants will take part in the study for about 24 weeks (about 6 months). There will be about 10 study clinic visits: a screening visit, Day 1, and then every 1, 2, or 4 weeks until week 16. At each visit, participants will report on their health and have tests such as physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will record when they take the study medicine and their HS symptoms every day in an eDiary on a mobile phone. The experiences of participants receiving the study medicine will be compared to those receiving placebo to help see if the study medicine is safe and effective.

Eligibility Criteria

Age Range: 18 years to 75 years

Key Eligibility Criteria: Inclusion Criteria: 1. Male or female participants ≥18 to ≤75 years of age. 2. Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS. Exclusion Criteria: 1. Presence of ≥20 draining fistulae at Screening or BL visit 2. Evidence of other active skin disease or condition at screening 3. Have a known immunodeficiency disorder 4. Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB 5. Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection 6. Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions 7. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years

Interventions

DRUG

Ritlecitinib

DRUG

Placebo

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Conditions

Hidradenitis Suppurativa

Locations

Medical Dermatology Specialists

Phoenix, Arizona 85006

United States

Mayo Clinic Hospital

Phoenix, Arizona 85054

United States

Mayo Clinic Specialty Building

Phoenix, Arizona 85054

United States

Mayo Clinic

Scottsdale, Arizona 85259

United States

Burke Pharmaceutical Research

Hot Springs, Arkansas 71913

United States

First OC Dermatology Research Inc

Fountain Valley, California 92708

United States

Carbon Health - Urgent Care - La Habra

La Habra, California 90631

United States

Northridge Clinical Trials

Northridge, California 91325

United States

Integrative Skin Science and Research

Sacramento, California 95815

United States

Wolverine Clinical Trials

Santa Ana, California 92706

United States

Skin Care Research

Boca Raton, Florida 33486

United States

Olympian Clinical Research

Largo, Florida 33770

United States

Ziaderm Research LLC

North Miami Beach, Florida 33162

United States

D&H Tamarac Research Center

Tamarac, Florida 33321

United States

NMC Research LLC

Tampa, Florida 33607

United States

USF - Carol and Frank Morsani Center for Advanced Healthcare-Clinical Research Center

Tampa, Florida 33612

United States

Alliance Clinical Research of Tampa

Tampa, Florida 33615

United States

Olympian Clinical Research

Tampa, Florida 33615

United States

USF Florida Hearing Clinic

Tampa, Florida 33620

United States

TruDerm & TruSpa

Wellington, Florida 33449

United States

Advanced Medical Research, PC.

Sandy Springs, Georgia 30328

United States

Endeavor Health

Skokie, Illinois 60077

United States

Whisper Hearing Center

Indianapolis, Indiana 46240

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46250

United States

Community Imaging Center

Indianapolis, Indiana 46256

United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana 46168

United States

Options Research Group

West Lafayette, Indiana 47906

United States

Essential Medical Research - Overland Park

Overland Park, Kansas 66213

United States

Skin and Hair Center

Overland Park, Kansas 66213

United States

DS Research of Kentucky

Louisville, Kentucky 40241

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Revival Research Institute, LLC

Southfield, Michigan 48034

United States

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska 68144

United States

Stracskin

Portsmouth, New Hampshire 03801

United States

DJL Clinical Research, PLLC

Charlotte, North Carolina 28211

United States

ClinOhio Research Services

Columbus, Ohio 43213

United States

Columbia Dermatology & Aesthetics

Columbia, South Carolina 29212

United States

Palmetto Clinical Trial Services - Greenville

Greenville, South Carolina 29615

United States

Center for Clinical Studies, LTD. LLP

Houston, Texas 77004

United States

Eurofins CRL

Forest, Virginia 24551

United States

Dermatology Research Institute

Calgary, Alberta T2J 7E1

Canada

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta T5J 3S9

Canada

Skin Physicians Dermatology

Edmonton, Alberta T6W 4V4

Canada

CaRe Clinic

Red Deer, Alberta T4P 1K4

Canada

Ryan Clinical Research Inc.

Newmarket, Ontario L3Y 5G8

Canada

DAR Clinical Research

Ottawa, Ontario K1V 1C1

Canada

North York Research Inc

Toronto, Ontario M2N 3A6

Canada

FACET Dermatology

Toronto, Ontario M4E 1R7

Canada

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4

Canada

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony 01307

Germany

Universitätsklinikum Frankfurt

Frankfurt, 60590

Germany

Universitätsklinikum Schleswig Holstein - Campus Lübeck

Lübeck, 23538

Germany

Athens Medical Center - Psychikon branch

Athens, Attica 11525

Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Thessaloníki 564 29

Greece

University General Hospital of Larissa

Larissa, Thessalía 411 10

Greece

Dermatological and Venereological Hospital Andreas Syggros

Athens, 161 21

Greece

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship 50-566

Poland

Penta Hospitals Badania Kliniczne sp. z o.o.

Gdansk, 80-546

Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400

Poland

Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu

Sosnowiec, 41-200

Poland

Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.

Szczecin, 71-500

Poland

Trialmed CRS - Warszawa

Warsaw, 02-482

Poland

Państwowy Instytut Medyczny MSWiA

Warsaw, 02-507

Poland

Klinika Ambroziak Dermatologia

Warsaw, 02-953

Poland

Royalderm Agnieszka Nawrocka

Warsaw, 02-962

Poland

Soft Skin Medical Center Dr Elzbieta Wojtowicz-Prus

Wroclaw, 50-551

Poland

Hospital de Manises

Manises, Valencia 46940

Spain

Hospital Universitario Puerta del Mar

Cadiz, 11009

Spain

Hospital Universitario Virgen Nieves

Granada, 18012

Spain

Hospital General Universitario Gregorio Maranon

Madrid, 28007

Spain

CHOP-Centro De Especialidades De Mollabao

Pontevedra, 36001

Spain