Activo, sin reclutamientoNCT07228390Registro de ClinicalTrials.gov

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.

Hidradenitis Suppurativa

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - 75 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 128 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento triple

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.

Drug: Ritlecitinib

Placebo

Participants will receive matching placebo.

Drug: Placebo

Ritlecitinib 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 DRUG

Participant will receive matching placebo

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

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.

Plazo: Week 16

The difference in proportion of responders based on HiSCR50 response at Week 16 in patients with HS treated with ritlecitinib versus placebo.

Medidas secundarias

Proportion of participants achieving HiSCR50 response

Plazo: at Weeks 1, 2, 4, 6, 8 and Week 12.

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

Plazo: at Weeks 1, 2, 4, 6, 8, 12 and Week 16.

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

Plazo: at Weeks 1, 2, 4, 6, 8, 12 and Week 16

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

Plazo: Week 16

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

Response based on a total AN count of 0, 1, or 2

Plazo: At week 16

The difference in proportion of responders based on a total AN count of 0, 1 or 2 at Week 16 in patients with HS treated with ritlecitinib and placebo.

Percent change from Baseline(CFB) in total AN count

Plazo: Weeks 1, 2, 4, 6, 8, 12 and 16.

The difference in mean percent CFB in total AN count at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

Absolute score in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)

Plazo: at Weeks 1, 2, 4, 6, 8, 12 and 16

The difference in mean absolute score in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

CFB in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)

Plazo: at Weeks 1, 2, 4, 6, 8, 12 and 16

Mean CFB in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

Proportion of participants achieving a HS-IGA=0 or 1

Plazo: Weeks 1, 2, 4, 6, 8, 12 and 16

The difference in proportion of responders based on HS-IGA=0 or 1 at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

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

Plazo: Weeks 4, 8, 12 and 16.

The difference in proportion of HS flare at Weeks 4, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

CFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD)

Plazo: Weeks 1, 2, 4, 6, 8, 12 and 16