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.

Conditions

• Hidradenitis Suppurativa

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

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.
• Placebo — DRUG
  Participant will receive matching placebo

Study Details

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.

Key Dates

Start date

Nov 13, 2025

Status verified

Apr 2026

Primary completion

Mar 5, 2027

Completion

Apr 2, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• Placebo Comparator: Placebo
  Participants will receive matching placebo.

Primary Outcome Measure

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. [ Time Frame: Week 16 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (32)

Find similar trials in Phoenix, AZ

Related Studies

• The Ohio State University Dermatology Biorepository
  Recruiting · Ohio State University · Columbus, Ohio
• Clinical and Biological Characteristics of Hidradenitis Suppurativa
  Recruiting · University of California, San Francisco · San Francisco, California
• Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository
  Recruiting · University of California, San Francisco · San Francisco, California
• Battlefield Acupuncture for Pain in Hidradenitis Suppurativa
  Recruiting · Wayne State University · Dearborn, Michigan