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A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)

RecruitingPhase 2Ages 10 Years - 17 YearsAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Fenebrutinib
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Where

17 sites
INECO Neurociencias Orono
Rosario, Argentina
Sanatorio del Sur S.A.
San Miguel de Tucumán, Argentina
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Brazil
Instituto de Neurologia de Curitiba - Hospital Ecoville
Curitiba, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre, Brazil
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, Brazil
Clinstile S.A de C.V.
Mexico City, Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, Mexico

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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