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RECRUITING
NCT07161258
PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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

Interventions

DRUG

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