An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07161258Tipo: INTERVENTIONALInicio: 6 de oct de 2025Fin estimado: 13 de feb de 2029

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Resumen

This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \< 18 years. This study consists of a Dose Exploration Period and an Optional Extension Period. Eligible participants may choose to continue treatment with fenebrutinib in the optional extension period after completing the dose exploration period.

Elegibilidad

Edad mínima: 10 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria and one or more of the following: at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 month
Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive
Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases

Criterios de exclusión

A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)
Co-morbid Conditions:
Potentially confounding neurological, somatic, or metabolic disorders
Current clinically significant psychiatric or medical illness
History of cancer, transplants, or bleeding disorders
Inability to complete an MRI scan or get gadolinium
Abnormal liver function tests or blood counts
Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets
Active, recurrent, or chronic infections
Recent or anticipated use of prohibited medications/treatments:
Certain disease-modifying therapy (DMT) and other immunosuppressants
Drugs interacting with fenebrutinib (Cytochrome P450 3A4 \[CYP3A4\] inhibitors)
Any other investigational therapy, anticoagulants, certain vaccines
A score of 4 or 5 on the "last 6 months" section of the screening SI section or "yes" on any item of the "last 6 months" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment

Intervenciones

drug

Fenebrutinib

Fenebrutinib will be administered orally.

Ubicaciones

INECO Neurociencias Orono

Rosario, Santa Fe Province, Argentina

RECRUITING

Sanatorio del Sur S.A.

San Miguel de Tucumán, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

Contactos

Reference Study ID Number: CN45847 https://forpatients.roche.com/

CONTACT

global-roche-genentech-trials@gene.com 888-662-6728 (U.S.)

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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