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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
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Northridge Clinical Trials
Northridge, California, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Revival Research Institute, LLC
Troy, Michigan, United States
ClinOhio Research Services
Columbus, Ohio, United States
Start Date
November 13, 2025
Primary Completion Date
March 5, 2027
Completion Date
April 2, 2027
Last Updated
November 24, 2025
240
ESTIMATED participants
Ritlecitinib
DRUG
Placebo
DRUG
Lead Sponsor
Pfizer
NCT06993233
NCT06888193
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07316192