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Ritlecitinib for adults with long‑lasting painful red skin lumps (hidradenitis suppurativa)

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

Phase 2 Interventional Pfizer · NCT07228390

This trial will test whether an oral medicine called ritlecitinib, taken once daily, can reduce symptoms in adults with moderate to severe hidradenitis suppurativa who did not get better with antibiotics.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsRitlecitinib
Locations54 sites (Phoenix, Arizona and 53 other locations)
Trial IDNCT07228390 on ClinicalTrials.gov

What this trial studies

Adults with moderate to severe hidradenitis suppurativa who previously had inadequate response or intolerance to oral antibiotics are randomly assigned to receive either oral ritlecitinib or a matching placebo. Treatment begins with a loading dose followed by a daily maintenance dose taken at home. The blind is maintained and participants attend about 10 clinic visits over roughly 24 weeks for safety and symptom checks. The study collects measures of lesion counts, draining lesions, safety labs, and patient‑reported symptoms to compare ritlecitinib against placebo.

Who should consider this trial

Good fit: Adults aged 18–75 with a clinical diagnosis of moderate to severe HS for at least 6 months and an inadequate response or intolerance to at least 28 days of oral antibiotics are the intended participants.

Not a fit: People with ≥20 draining fistulae, other active skin diseases, known immunodeficiency, certain prior serious or specific viral infections, a recent history of severe uncontrolled medical or psychiatric conditions, or other listed exclusions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, ritlecitinib could reduce painful inflammatory nodules and draining lesions and improve quality of life for adults with moderate to severe HS who have not responded to antibiotics.

How similar studies have performed: Oral JAK/TEC pathway inhibitors have shown promise in several inflammatory skin conditions and ritlecitinib has activity in related diseases, but its use specifically in HS is relatively new.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Eligibility Criteria:

Inclusion Criteria:

1. Male or female participants ≥18 to ≤75 years of age.
2. 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.

Exclusion Criteria:

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

Where this trial is running

Phoenix, Arizona and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis SuppurativaRitlecitinib
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.