Actively Recruiting
An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis
Led by Hoffmann-La Roche · Updated on 2026-05-08
12
Participants Needed
17
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of fenebrutinib in children and adolescents aged 10 to under 18 years with relapsing multiple sclerosis (RMS). This Phase 2 open-label, single-arm study aims to understand how fenebrutinib behaves in this younger population and its effects on the disease, with the sponsor being Hoffmann-La Roche. Participants will receive fenebrutinib orally during a Dose Exploration Period. After completing this period, eligible participants may choose to continue treatment in an Optional Extension Period. The study includes monitoring of plasma concentration of fenebrutinib up to week 96 and assessment of new brain lesions using MRI scans at week 12. Throughout the study, participants will undergo various safety and health assessments including monitoring for adverse events, suicidal ideation or behavior, vital signs such as pulse rate and blood pressure, electrocardiogram parameters, and clinical laboratory tests. The total duration of observation may extend up to approximately 100 weeks, allowing detailed evaluation of fenebrutinib's effects and tolerability in this age group.
CONDITIONS
Brief Title
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsing multiple sclerosis according to pediatric IPMSSG and revised McDonald Criteria
- At least one MS relapse in the past year or two relapses in the past 2 years or at least one gadolinium-enhancing lesion on MRI within 6 months
- Expanded Disability Status Scale (EDSS) score between 0 and 5.5 points at screening
- Children and adolescents must have received all local or national childhood vaccinations
You will not qualify if you...
- Diagnosis of primary progressive MS or non-active secondary progressive MS
- Other neurological, somatic, or metabolic disorders that may affect the study
- Current significant psychiatric or medical illness
- History of cancer, organ transplants, or bleeding disorders
- Unable to complete MRI or receive gadolinium contrast
- Abnormal liver function tests or blood counts
- Sensitivity or intolerance to fenebrutinib or its ingredients
- Active, recurrent, or chronic infections
- Recent or expected use of prohibited medications including certain immunosuppressants, CYP3A4 inhibitors, anticoagulants, vaccines, or other investigational therapies
- High risk of suicide based on screening assessments or investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 96 weeks
Participants receive fenebrutinib orally to treat relapsing multiple sclerosis.
Regular visits for assessments during treatment
Duration - Up to approximately 4 weeks after treatment
Participants are monitored for safety and tolerability after treatment ends.
1 to 2 visits
Trial Site Locations
Total: 17 locations
1
INECO Neurociencias Orono
Rosario, Santa Fe Province, Argentina, S2000DTB
Actively Recruiting
2
Sanatorio del Sur S.A.
San Miguel de Tucumán, Argentina, T4000IDK
Actively Recruiting
3
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil, 70200-730
Actively Recruiting
4
Instituto de Neurologia de Curitiba - Hospital Ecoville
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
5
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
Actively Recruiting
6
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, Brazil, 01228-200
Actively Recruiting
7
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico, 06700
Actively Recruiting
8
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, Mexico, 80020
Actively Recruiting
9
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80 952
Actively Recruiting
10
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland, 60-355
Actively Recruiting
11
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, Poland, 04-730
Actively Recruiting
12
Centro Clnico Acadmico - Braga, Associao (2CA-Braga)
Braga, Portugal, 4710-243
Actively Recruiting
13
Unidade Local de Saude de Coimbra E P E
Coimbra, Portugal, 3000-602
Actively Recruiting
14
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
15
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
16
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
17
UH of State NPC Danulo Halytsky NMU in Lviv CID, Clinic of Neurology and Neurosurgery
Lviv, Ukraine, 79010
Actively Recruiting
Research Team
R
Reference Study ID Number: CN45847 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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