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.

StatusActive, Not Recruiting
PhasePhase 2
SponsorPfizer
Started

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Record History

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  1. Minor Trial sites reduced: 67 → 60 locations
    • Eligibility criteria expanded, about 9 words
  2. Minor Enrollment closed, study ongoingv5 Show 4 more changesShow less
    • Trial sites reduced: 71 → 67 locations
    • Final enrollment: 128 participants (planned 240)
    • Primary completion moved earlier from Mar 5, 2027 to Dec 8, 2026
    • Study completion moved earlier from Apr 2, 2027 to Jan 5, 2027
  3. Minor Trial sites expanded: 54 → 71 locationsv4
  4. Minor Study sites: 4 to 54v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 4
    • Start date changed from estimate of Nov 5, 2025 to Nov 13, 2025
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07228390
Lead Sponsor Pfizer
Conditions
(from sponsor)
Hidradenitis Suppurativa
Related terms Hidradenitis Suppurativa
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov