Actively Recruiting
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled 16-Week Study Evaluating the Safety and Efficacy of Ritlecitinib in Adults With Moderate to Severe Hidradenitis Suppurativa
Led by Pfizer · Updated on 2026-04-29
240
Participants Needed
54
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa (HS), a condition causing long-lasting painful red skin lumps. The study focuses on participants who have not responded well to antibiotics or could not tolerate them. This is a phase 2, randomized, double-blind, placebo-controlled trial to evaluate how well Ritlecitinib works compared to a placebo. Participants will be randomly assigned to receive either Ritlecitinib or a placebo pill that looks the same but contains no medicine. Those in the treatment group will take an oral loading dose once daily for 8 weeks, followed by a maintenance dose once daily for another 8 weeks. The placebo group will receive matching placebo pills on the same schedule. The total study duration is about 16 weeks. During the study, participants will attend about 10 clinic visits including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until week 16. At each visit, health status will be checked through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also use an electronic diary on their mobile phones to record daily medication intake and HS symptoms. The main measurement is the proportion of participants achieving a 50% reduction in HS symptoms by week 16. Safety and other symptom improvements will also be monitored.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years
- Diagnosis of moderate to severe hidradenitis suppurativa for at least 6 months before screening
- Inadequate response to at least 4 weeks of oral antibiotics for hidradenitis suppurativa treatment
You will not qualify if you...
- Presence of 20 or more draining fistulae at screening or baseline visit
- Active skin disease or condition other than hidradenitis suppurativa at screening
- Known immunodeficiency disorder
- History of systemic infection requiring hospitalization or IV therapy, including tuberculosis infection
- History of herpes zoster, hepatitis B virus, or hepatitis C virus infection
- Clinically significant severe, progressive, or uncontrolled medical conditions
- Medical or psychiatric conditions including active suicidal thoughts in the past year or suicidal behavior in the past 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive one oral dose of the study medicine or placebo once daily, starting with a loading dose for 8 weeks followed by maintenance for 8 weeks.
Visits at Weeks 1, 2, 4, 6, 8, 12, and 16 for assessments
Trial Site Locations
Total: 54 locations
1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
3
First OC Dermatology Research Inc
Fountain Valley, California, United States, 92708
Not Yet Recruiting
4
Carbon Health - Urgent Care - La Habra
La Habra, California, United States, 90631
Not Yet Recruiting
5
Northridge Clinical Trials
Northridge, California, United States, 91325
Actively Recruiting
6
Wolverine Clinical Trials
Santa Ana, California, United States, 92706
Not Yet Recruiting
7
Skin Care Research
Boca Raton, Florida, United States, 33486
Not Yet Recruiting
8
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33162
Not Yet Recruiting
9
D&H Tamarac Research Center
Tamarac, Florida, United States, 33321
Actively Recruiting
10
NMC Research LLC
Tampa, Florida, United States, 33607
Not Yet Recruiting
11
USF - Carol and Frank Morsani Center for Advanced Healthcare-Clinical Research Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
12
Alliance Clinical Research of Tampa
Tampa, Florida, United States, 33615
Not Yet Recruiting
13
USF Florida Hearing Clinic
Tampa, Florida, United States, 33620
Not Yet Recruiting
14
TruDerm & TruSpa
Wellington, Florida, United States, 33449
Not Yet Recruiting
15
Advanced Medical Research, PC.
Sandy Springs, Georgia, United States, 30328
Not Yet Recruiting
16
Endeavor Health
Skokie, Illinois, United States, 60077
Not Yet Recruiting
17
Whisper Hearing Center
Indianapolis, Indiana, United States, 46240
Not Yet Recruiting
18
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Not Yet Recruiting
19
Community Imaging Center
Indianapolis, Indiana, United States, 46256
Not Yet Recruiting
20
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
Not Yet Recruiting
21
Options Research Group
West Lafayette, Indiana, United States, 47906
Actively Recruiting
22
Essential Medical Research - Overland Park
Overland Park, Kansas, United States, 66213
Actively Recruiting
23
Skin and Hair Center
Overland Park, Kansas, United States, 66213
Actively Recruiting
24
DS Research of Kentucky
Louisville, Kentucky, United States, 40241
Not Yet Recruiting
25
Revival Research Institute, LLC
Troy, Michigan, United States, 48084
Actively Recruiting
26
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, United States, 68144
Not Yet Recruiting
27
Stracskin
Portsmouth, New Hampshire, United States, 03801
Actively Recruiting
28
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28211
Not Yet Recruiting
29
ClinOhio Research Services
Columbus, Ohio, United States, 43213
Not Yet Recruiting
30
Columbia Dermatology & Aesthetics
Columbia, South Carolina, United States, 29212
Not Yet Recruiting
31
Palmetto Clinical Trial Services - Greenville
Greenville, South Carolina, United States, 29615
Not Yet Recruiting
32
Eurofins CRL
Forest, Virginia, United States, 24551
Not Yet Recruiting
33
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, Canada, T5J 3S9
Not Yet Recruiting
34
CaRe Clinic
Red Deer, Alberta, Canada, T4P 1K4
Actively Recruiting
35
Ryan Clinical Research Inc.
Newmarket, Ontario, Canada, L3Y 5G8
Actively Recruiting
36
DAR Clinical Research
Ottawa, Ontario, Canada, K1V 1C1
Not Yet Recruiting
37
North York Research Inc
Toronto, Ontario, Canada, M2N 3A6
Not Yet Recruiting
38
FACET Dermatology
Toronto, Ontario, Canada, M4E 1R7
Actively Recruiting
39
Centre de Recherche Saint-Louis inc.
Québec, Canada, G1W 4R4
Not Yet Recruiting
40
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, Germany, 01307
Not Yet Recruiting
41
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538
Not Yet Recruiting
42
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Not Yet Recruiting
43
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
Not Yet Recruiting
44
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland, 80-546
Not Yet Recruiting
45
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
Sosnowiec, Poland, 41-200
Not Yet Recruiting
46
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Szczecin, Poland, 71-500
Not Yet Recruiting
47
Trialmed CRS - Warszawa
Warsaw, Poland, 02-482
Not Yet Recruiting
48
Państwowy Instytut Medyczny MSWiA
Warsaw, Poland, 02-507
Not Yet Recruiting
49
Klinika Ambroziak Dermatologia
Warsaw, Poland, 02-953
Not Yet Recruiting
50
Royalderm Agnieszka Nawrocka
Warsaw, Poland, 02-962
Not Yet Recruiting
51
Soft Skin Medical Center Dr Elzbieta Wojtowicz-Prus
Wroclaw, Poland, 50-551
Not Yet Recruiting
52
Hospital Universitario Puerta del Mar
Cadiz, Spain, 11009
Actively Recruiting
53
Hospital Universitario Virgen Nieves
Granada, Spain, 18014
Not Yet Recruiting
54
CHOP-Centro De Especialidades De Mollabao
Pontevedra, Spain, 36001
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here