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A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Sponsor: Hoffmann-La Roche
Summary
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.
Official title: An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-10-06
Completion Date
2029-02-13
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Fenebrutinib
Fenebrutinib will be administered orally.
Locations (17)
INECO Neurociencias Orono
Rosario, Santa Fe Province, Argentina
Sanatorio del Sur S.A.
San Miguel de Tucumán, Argentina
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
Instituto de Neurologia de Curitiba - Hospital Ecoville
Curitiba, Paraná, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, Brazil
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, Poland
Centro Clnico Acadmico - Braga, Associao (2CA-Braga)
Braga, Portugal
Unidade Local de Saude de Coimbra E P E
Coimbra, Portugal
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
Lviv, KIEV Governorate, Ukraine