ReclutandoNCT07203001Registro de ClinicalTrials.gov

A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease

Still´s Disease

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 1 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 30 Estimado

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 study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease

Leer la descripción completa

This is a multicenter, open-label, single-arm study to assess clinical efficacy, safety and tolerability of MAS825 in participants (both pediatric and adult) with Still's disease who have had inadequate response to IL-1 and/or IL-6 or other available therapies. Participants with associated lung disease and/or macrophage activation syndrome may also be included.

This study has three periods (Screening, Treatment Period 1, and Treatment Period 2) and a total duration of approximately 16 months.

¿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.

Inclusion Criteria:

Age ≥ 1 with a diagnosis of Still's Disease
Active diseases defined as:
CRP or ferritin levels greater than ULN, and any of:

Fever ≥ 38°C attributed to Still's Disease activity and documented for a number of days prior to Day 1 or
Rash attributed to Still's Disease activity or
Musculoskeletal involvement: arthritis in a number of joints per ACP criteria for active joint or
Serositis or
Macrophage activation syndrome activity as defined by ferritin levels and at least one of: platelet count, a biomarker or fibrinogen levels attributed to Still's Disease activity by the investigator
Intolerance or inadequate response to available biologic therapy

Exclusion Criteria:

Patients out of weight range
Ongoing or previous treatment with immunomodulatory drugs

A limited number of Still's Disease patients that have previously received MAS825 through a managed access program are permitted on the study
Glucocorticoid dose exceeding a set limit
Any conditions or significant medical problems which places the patient at unacceptable risk for MAS825 therapy

Still's disease patients with evidence of macrophage activation syndrome are permitted in the study
Still's Disease patients with evidence of interstitial lung disease including those requiring supplemental oxygen therapy are permitted in the study
History of ongoing, chronic or possibly recurrent infection (e.g. HIV, TB, HCV, HBV) and/or symptoms and signs of clinically significant active bacterial, fungal or viral infections
Live vaccinations within a set time prior to MAS825 treatment. Live vaccines are prohibited up to several months following the last dose
History of malignancy of any organ system, including post-transplant lymphoproliferative disorder, treated or untreated, within a number of years, regardless of whether there is evidence of local recurrence and metastases
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to any of the excipients
Pregnant or breastfeeding women
Women of child-bearing potential who do not agree to comply with required contraceptive use

Other protocol-defined inclusion/exclusion criteria may apply.

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: No aplica
Enmascaramiento: Sin enmascaramiento

MAS825

Experimental drug

Drug: MAS825

MAS825 DRUG

Experimental drug

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

Number of participants with clinical response based on one set of response criteria

Plazo: Day 85

Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.

Medidas secundarias

Number of participants with clinical response based on another set of response criteria

Plazo: Day 85

Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.

Response based on a biomarker level

Plazo: Baseline, Day 85

To evaluate the efficacy of MAS825 in reducing clinical disease activity

Change in physician assessment based on laboratory features of MAS825

Plazo: Baseline, 15 months

To assess the effect of MAS825 on macrophage activation syndrome

Change from baseline in Glucocorticoid (GC) dose

Plazo: Baseline, Day 85, Month 6, Month 12

To evaluate the efficacy of MAS825 as a glucocorticoid-sparing agent

Change from baseline in patient/parent assessment of physical function as assessed by Quality of Life instrument

Plazo: Baseline, Day 85

To evaluate the efficacy of MAS825 in improving participant's quality of life

Clinically inactive disease whilst on non-treatment dose corticosteroid at any time during the study

Plazo: 15 months

The number of participants with inactive disease will be assessed. Disease activity will be evaluated by the investigator based on physical examination and laboratory parameters.

Inactive disease is defined according to protocol-specific criteria, which include clinical signs, laboratory values, and physician assessment.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (24)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

Buscar un centro en este estudio

24 centros

Cincinnati Childrens HospitalCincinnati, Ohio, United StatesActivo, sin reclutamiento

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (24)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research