Actively Recruiting
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Led by Hoffmann-La Roche · Updated on 2026-05-08
12
Participants Needed
17
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (RMS) according to pediatric MS criteria and revised McDonald Criteria
- At least one MS relapse in the past year, or two relapses in the past two years, or at least one gadolinium-enhancing lesion on MRI within 6 months
- Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at screening
- Children and adolescents must have received all recommended childhood vaccinations according to local/national guidelines
You will not qualify if you...
- Diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)
- Presence of confounding neurological, somatic, or metabolic disorders
- Current significant psychiatric or medical illness
- History of cancer, organ transplants, or bleeding disorders
- Unable to complete MRI scan 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 planned use of prohibited medications including certain disease-modifying therapies, immunosuppressants, CYP3A4 inhibitors, investigational drugs, anticoagulants, or certain vaccines
- High risk or recent history of suicidal behavior or significant suicide risk as assessed by screening questionnaires and investigator judgment
AI-Screening
AI-Powered Screening
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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/
CONTACT
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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