Find Hidradenitis Suppurativa Clinical Trials Near You
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
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female participants ≥18 to ≤75 years of age.
• 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.
Locations
United States
Arkansas
Burke Pharmaceutical Research
RECRUITING
Hot Springs
Arizona
Medical Dermatology Specialists
RECRUITING
Phoenix
California
First OC Dermatology Research Inc
NOT_YET_RECRUITING
Fountain Valley
Carbon Health - Urgent Care - La Habra
NOT_YET_RECRUITING
La Habra
Northridge Clinical Trials
RECRUITING
Northridge
Wolverine Clinical Trials
NOT_YET_RECRUITING
Santa Ana
Florida
Skin Care Research
NOT_YET_RECRUITING
Boca Raton
Ziaderm Research LLC
NOT_YET_RECRUITING
North Miami Beach
D&H Tamarac Research Center
RECRUITING
Tamarac
Alliance Clinical Research of Tampa
NOT_YET_RECRUITING
Tampa
NMC Research LLC
NOT_YET_RECRUITING
Tampa
USF - Carol and Frank Morsani Center for Advanced Healthcare-Clinical Research Center
NOT_YET_RECRUITING
Tampa
USF Florida Hearing Clinic
NOT_YET_RECRUITING
Tampa
TruDerm & TruSpa
NOT_YET_RECRUITING
Wellington
Georgia
Advanced Medical Research, PC.
NOT_YET_RECRUITING
Sandy Springs
Illinois
Endeavor Health
NOT_YET_RECRUITING
Skokie
Indiana
Community Imaging Center
NOT_YET_RECRUITING
Indianapolis
Dawes Fretzin Clinical Research Group, LLC
NOT_YET_RECRUITING
Indianapolis
Whisper Hearing Center
NOT_YET_RECRUITING
Indianapolis
The Indiana Clinical Trials Center, PC
NOT_YET_RECRUITING
Plainfield
Options Research Group
RECRUITING
West Lafayette
Kansas
Essential Medical Research - Overland Park
RECRUITING
Overland Park
Skin and Hair Center
RECRUITING
Overland Park
Kentucky
DS Research of Kentucky
NOT_YET_RECRUITING
Louisville
Michigan
Revival Research Institute, LLC
RECRUITING
Troy
North Carolina
DJL Clinical Research, PLLC
NOT_YET_RECRUITING
Charlotte
Nebraska
Skin Specialists, PC dba Schlessinger MD
NOT_YET_RECRUITING
Omaha
New Hampshire
Stracskin
RECRUITING
Portsmouth
Ohio
ClinOhio Research Services
NOT_YET_RECRUITING
Columbus
South Carolina
Columbia Dermatology & Aesthetics
NOT_YET_RECRUITING
Columbia
Palmetto Clinical Trial Services - Greenville
NOT_YET_RECRUITING
Greenville
Virginia
Eurofins CRL
NOT_YET_RECRUITING
Forest
Other Locations
Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc
NOT_YET_RECRUITING
Edmonton
Ryan Clinical Research Inc.
RECRUITING
Newmarket
DAR Clinical Research
NOT_YET_RECRUITING
Ottawa
Centre de Recherche Saint-Louis inc.
NOT_YET_RECRUITING
Québec
CaRe Clinic
RECRUITING
Red Deer
FACET Dermatology
RECRUITING
Toronto
North York Research Inc
NOT_YET_RECRUITING
Toronto
Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
NOT_YET_RECRUITING
Dresden
Universitätsklinikum Frankfurt
NOT_YET_RECRUITING
Frankfurt
Universitätsklinikum Schleswig-Holstein
NOT_YET_RECRUITING
Lübeck
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
NOT_YET_RECRUITING
Gdansk
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
NOT_YET_RECRUITING
Sosnowiec
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Soft Skin Medical Center Dr Elzbieta Wojtowicz-Prus
NOT_YET_RECRUITING
Wroclaw
Spain
Hospital Universitario Puerta del Mar
RECRUITING
Cadiz
Hospital Universitario Virgen Nieves
NOT_YET_RECRUITING
Granada
CHOP-Centro De Especialidades De Mollabao
RECRUITING
Pontevedra
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2025-11-13
Estimated Completion Date:2027-04-02
Participants
Target number of participants:240
Treatments
Experimental: Study Intervention
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.