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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-13

Study Completion Date

2027-04-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Ritlecitinib

Intervention Type 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

Participants will receive matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participant will receive matching placebo

Interventions

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Ritlecitinib

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.

Intervention Type DRUG

Placebo

Participant will receive matching placebo

Intervention Type DRUG

Other Intervention Names

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Investigational Product

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No