RecruitingPhase 2NCT07161258

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

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


Sponsor

Hoffmann-La Roche

Enrollment

12 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called fenebrutinib in children and teenagers who have relapsing multiple sclerosis (MS) — a condition where the immune system attacks the nervous system, causing episodes of symptoms that come and go. The study looks at how the drug moves through the body and whether it is safe for young people. **You may be eligible if...** - You are a child or adolescent diagnosed with relapsing MS - You have had at least one MS flare-up in the past year, or two in the past two years, or an active lesion on MRI - Your disability level falls within an accepted range on a standard MS scale - You are up to date on all recommended childhood vaccines **You may NOT be eligible if...** - You have a type of MS that is primarily progressive (never gets better) - You have significant other neurological, psychiatric, or serious medical conditions - You have had cancer, an organ transplant, or a bleeding disorder - You cannot have an MRI - You are currently on certain MS medications or immune-suppressing drugs - You are pregnant or at significant risk of suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFenebrutinib

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

View Full Details on ClinicalTrials.gov

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NCT07161258


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