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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.
Sponsor: Pfizer
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.
Official title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF RITLECITINIB (PF-06651600) IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-11-13
Completion Date
2027-04-02
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
Ritlecitinib
Participants will receive one oral dose once daily (QD), starting with a loading dose of ritlecitinib for 8 weeks, followed by maintenance for 8 weeks.
Placebo
Participant will receive matching placebo
Locations (54)
Medical Dermatology Specialists
Phoenix, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Carbon Health - Urgent Care - La Habra
La Habra, California, United States
Northridge Clinical Trials
Northridge, California, United States
Wolverine Clinical Trials
Santa Ana, California, United States
Skin Care Research
Boca Raton, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
D&H Tamarac Research Center
Tamarac, Florida, United States
NMC Research LLC
Tampa, Florida, United States
USF - Carol and Frank Morsani Center for Advanced Healthcare-Clinical Research Center
Tampa, Florida, United States
Alliance Clinical Research of Tampa
Tampa, Florida, United States
USF Florida Hearing Clinic
Tampa, Florida, United States
TruDerm & TruSpa
Wellington, Florida, United States
Advanced Medical Research, PC.
Sandy Springs, Georgia, United States
Endeavor Health
Skokie, Illinois, United States
Whisper Hearing Center
Indianapolis, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Community Imaging Center
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Options Research Group
West Lafayette, Indiana, United States
Essential Medical Research - Overland Park
Overland Park, Kansas, United States
Skin and Hair Center
Overland Park, Kansas, United States
DS Research of Kentucky
Louisville, Kentucky, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, United States
Stracskin
Portsmouth, New Hampshire, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
ClinOhio Research Services
Columbus, Ohio, United States
Columbia Dermatology & Aesthetics
Columbia, South Carolina, United States
Palmetto Clinical Trial Services - Greenville
Greenville, South Carolina, United States
Eurofins CRL
Forest, Virginia, United States
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, Canada
CaRe Clinic
Red Deer, Alberta, Canada
Ryan Clinical Research Inc.
Newmarket, Ontario, Canada
DAR Clinical Research
Ottawa, Ontario, Canada
North York Research Inc
Toronto, Ontario, Canada
FACET Dermatology
Toronto, Ontario, Canada
Centre de Recherche Saint-Louis inc.
Québec, Canada
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
Sosnowiec, Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Szczecin, Poland
Trialmed CRS - Warszawa
Warsaw, Poland
Państwowy Instytut Medyczny MSWiA
Warsaw, Poland
Klinika Ambroziak Dermatologia
Warsaw, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Poland
Soft Skin Medical Center Dr Elzbieta Wojtowicz-Prus
Wroclaw, Poland
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital Universitario Virgen Nieves
Granada, Spain
CHOP-Centro De Especialidades De Mollabao
Pontevedra, Spain