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.
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
Interventions
Ritlecitinib
Placebo
Conditions
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