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.

NCT07228390 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: B79811192025-522705-37-00
• Study Type: interventional
• Target: 240
• Locations: 5 countries
• Sites: 54

Brief 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.

Conditions

Hidradenitis Suppurativa

Keywords

Ritlecitinib

Outcome Measures

Primary Outcomes (1)

• Difference in proportion of responders based on Hidradenitis Suppurativa Clinical Response achieving at least 50% reduction from baseline (Hidradenitis Suppurativa Clinical Response HiSCR50) in patients with HS treated with ritlecitinib versus placebo.

  The difference in proportion of responders based on HiSCR50 response at Week 16 in patients with HS treated with ritlecitinib versus placebo.

  Week 16

Secondary Outcomes (20)

• Proportion of participants achieving HiSCR50 response

  at Weeks 1, 2, 4, 6, 8 and Week 12.

• Proportion of participants achieving HiSCR75 response

  at Weeks 1, 2, 4, 6, 8, 12 and Week 16.

• Proportion of participants achieving HiSCR90 response

  at Weeks 1, 2, 4, 6, 8, 12 and Week 16

• Response based on a on total abscess and inflammatory nodule count (AN Count) of 0 or 1

  Week 16

• Response based on a total AN count of 0, 1, or 2

  At week 16

Study Arms (2)

Study Intervention

EXPERIMENTAL

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.

Drug: Ritlecitinib

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo.

Drug: Placebo

Interventions

Ritlecitinib DRUG

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.

Also known as: Investigational Product

Study Intervention

Placebo DRUG

Participant will receive matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of ≥20 draining fistulae at Screening or BL visit
• Evidence of other active skin disease or condition at screening
• Have a known immunodeficiency disorder
• Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
• Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
• Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

RECRUITING

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

RECRUITING

First OC Dermatology Research Inc

Fountain Valley, California, 92708, United States

NOT YET RECRUITING

Carbon Health - Urgent Care - La Habra

La Habra, California, 90631, United States

NOT YET RECRUITING

Northridge Clinical Trials

Northridge, California, 91325, United States

RECRUITING

Wolverine Clinical Trials

Santa Ana, California, 92706, United States

NOT YET RECRUITING

Skin Care Research

Boca Raton, Florida, 33486, United States

NOT YET RECRUITING

Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

NOT YET RECRUITING

D&H Tamarac Research Center

Tamarac, Florida, 33321, United States

RECRUITING

NMC Research LLC

Tampa, Florida, 33607, United States

NOT YET RECRUITING

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

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

NOT YET RECRUITING

USF Florida Hearing Clinic

Tampa, Florida, 33620, United States

NOT YET RECRUITING

TruDerm & TruSpa

Wellington, Florida, 33449, United States

NOT YET RECRUITING

Advanced Medical Research, PC.

Sandy Springs, Georgia, 30328, United States

NOT YET RECRUITING

Endeavor Health

Skokie, Illinois, 60077, United States

NOT YET RECRUITING

Whisper Hearing Center

Indianapolis, Indiana, 46240, United States

NOT YET RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

NOT YET RECRUITING

Community Imaging Center

Indianapolis, Indiana, 46256, United States

NOT YET RECRUITING

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

NOT YET RECRUITING

Options Research Group

West Lafayette, Indiana, 47906, United States

RECRUITING

Essential Medical Research - Overland Park

Overland Park, Kansas, 66213, United States

RECRUITING

Skin and Hair Center

Overland Park, Kansas, 66213, United States

RECRUITING

DS Research of Kentucky

Louisville, Kentucky, 40241, United States

NOT YET RECRUITING

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

RECRUITING

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, 68144, United States

NOT YET RECRUITING

Stracskin

Portsmouth, New Hampshire, 03801, United States

RECRUITING

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28211, United States

NOT YET RECRUITING

ClinOhio Research Services

Columbus, Ohio, 43213, United States

NOT YET RECRUITING

Columbia Dermatology & Aesthetics

Columbia, South Carolina, 29212, United States

NOT YET RECRUITING

Palmetto Clinical Trial Services - Greenville

Greenville, South Carolina, 29615, United States

NOT YET RECRUITING

Eurofins CRL

Forest, Virginia, 24551, United States

NOT YET RECRUITING

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta, T5J 3S9, Canada

NOT YET RECRUITING

CaRe Clinic

Red Deer, Alberta, T4P 1K4, Canada

RECRUITING

Ryan Clinical Research Inc.

Newmarket, Ontario, L3Y 5G8, Canada

RECRUITING

DAR Clinical Research

Ottawa, Ontario, K1V 1C1, Canada

NOT YET RECRUITING

North York Research Inc

Toronto, Ontario, M2N 3A6, Canada

NOT YET RECRUITING

FACET Dermatology

Toronto, Ontario, M4E 1R7, Canada

RECRUITING

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4, Canada

NOT YET RECRUITING

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony, 01307, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

NOT YET RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

NOT YET RECRUITING

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

NOT YET RECRUITING

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, 80-546, Poland

NOT YET RECRUITING

Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu

Sosnowiec, 41-200, Poland

NOT YET RECRUITING

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

Szczecin, 71-500, Poland

NOT YET RECRUITING

Trialmed CRS - Warszawa

Warsaw, 02-482, Poland

NOT YET RECRUITING

Państwowy Instytut Medyczny MSWiA

Warsaw, 02-507, Poland

NOT YET RECRUITING

Klinika Ambroziak Dermatologia

Warsaw, 02-953, Poland

NOT YET RECRUITING

Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland

NOT YET RECRUITING

Soft Skin Medical Center Dr Elzbieta Wojtowicz-Prus

Wroclaw, 50-551, Poland

NOT YET RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

RECRUITING

Hospital Universitario Virgen Nieves

Granada, 18014, Spain

NOT YET RECRUITING

CHOP-Centro De Especialidades De Mollabao

Pontevedra, 36001, Spain

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 14, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): April 2, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (32); DE (3); CA (7); PL (9); ES (3)