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.

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат Placebo
  Participant will receive matching placebo

Первичные конечные точки

• 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. [Срок оценки: Week 16]

Вторичные конечные точки (12)

• Proportion of participants achieving HiSCR50 response [Срок оценки: at Weeks 1, 2, 4, 6, 8 and Week 12.]
• Proportion of participants achieving HiSCR75 response [Срок оценки: at Weeks 1, 2, 4, 6, 8, 12 and Week 16.]
• Proportion of participants achieving HiSCR90 response [Срок оценки: at Weeks 1, 2, 4, 6, 8, 12 and Week 16]
• Response based on a on total abscess and inflammatory nodule count (AN Count) of 0 or 1 [Срок оценки: Week 16]
• Response based on a total AN count of 0, 1, or 2 [Срок оценки: At week 16]
• Percent change from Baseline(CFB) in total AN count [Срок оценки: Weeks 1, 2, 4, 6, 8, 12 and 16.]
• Absolute score in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA) [Срок оценки: at Weeks 1, 2, 4, 6, 8, 12 and 16]
• CFB in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA) [Срок оценки: at Weeks 1, 2, 4, 6, 8, 12 and 16]
• Proportion of participants achieving a HS-IGA=0 or 1 [Срок оценки: Weeks 1, 2, 4, 6, 8, 12 and 16]
• Participants who experience an HS flare, defined as at least a 25% increase in total AN count with a minimum increase of 2 relative to Baseline [Срок оценки: Weeks 4, 8, 12 and 16.]
• CFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) [Срок оценки: Weeks 1, 2, 4, 6, 8, 12 and 16]
• Skin pain NRS30 (numeric rating scale) response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3 [Срок оценки: Weeks 1, 2, 4, 6, 8, 12, and 16]

Критерии участия

Key Eligibility Criteria:

Критерии включения

• 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.

Критерии исключения

• 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
• Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
• Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 40 центров

• Medical Dermatology Specialists — Phoenix
• Mayo Clinic Hospital — Phoenix
• Mayo Clinic Specialty Building — Phoenix
• Mayo Clinic — Scottsdale
• Burke Pharmaceutical Research — Hot Springs
• First OC Dermatology Research Inc — Fountain Valley
• Carbon Health - Urgent Care - La Habra — La Habra
• Northridge Clinical Trials — Northridge
• … и ещё 32 центра

Польша · 10 центров

• Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska — Wroclaw
• Penta Hospitals Badania Kliniczne sp. z o.o. — Gdansk
• Dermedic Jacek Zdybski — Ostrowiec Świętokrzyski
• Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu — Sosnowiec
• Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. — Szczecin
• Trialmed CRS - Warszawa — Warsaw
• Państwowy Instytut Medyczny MSWiA — Warsaw
• Klinika Ambroziak Dermatologia — Warsaw
• … и ещё 2 центра

Канада · 9 центров

• Dermatology Research Institute — Calgary
• Laser Rejuvenation Clinics Edmonton D.T. Inc — Edmonton
• Skin Physicians Dermatology — Edmonton
• CaRe Clinic — Red Deer
• Ryan Clinical Research Inc. — Newmarket
• DAR Clinical Research — Ottawa
• North York Research Inc — Toronto
• FACET Dermatology — Toronto
• … и ещё 1 центр

Испания · 5 центров

• Hospital de Manises — Manises
• Hospital Universitario Puerta del Mar — Cadiz
• Hospital Universitario Virgen Nieves — Granada
• Hospital General Universitario Gregorio Maranon — Madrid
• CHOP-Centro De Especialidades De Mollabao — Pontevedra

Греция · 4 центра

• Athens Medical Center - Psychikon branch — Athens
• Papageorgiou General Hospital of Thessaloniki — Thessaloniki
• University General Hospital of Larissa — Larissa
• Dermatological and Venereological Hospital Andreas Syggros — Athens

Германия · 3 центра

• Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden — Dresden
• Universitätsklinikum Frankfurt — Frankfurt
• Universitätsklinikum Schleswig Holstein - Campus Lübeck — Lübeck

Идентификаторы

NCT: NCT07228390 · B7981119 · 2025-522705-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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