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.
Male or female participants ≥18 to ≤75 years of age.
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.
Presence of ≥20 draining fistulae at Screening or BL visit
Evidence of other active skin disease or condition at screening
Have a known immunodeficiency disorder
Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
Parallel
Ritlecitinib
DrugParticipants 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
DrugParticipant will receive matching placebo
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.
The difference in proportion of responders based on HiSCR50 response at Week 16 in patients with HS treated with ritlecitinib versus placebo.
Proportion of participants achieving HiSCR50 response
The difference in proportion of responders based on HiSCR50 response at Weeks 1, 2, 4, 6, 8 and 12 in patients with HS treated with ritlecitinib versus placebo
Proportion of participants achieving HiSCR75 response
The difference in proportion of responders based on HISCR75 response at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib versus placebo
Proportion of participants achieving HiSCR90 response
The difference in proportion of responders based on HiSCR90 response at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib versus placebo
Response based on a on total abscess and inflammatory nodule count (AN Count) of 0 or 1
The difference in proportion of responders based on a total AN count of 0 or 1 at Week 16 in patients with HS treated with ritlecitinib and placebo
