A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
NCT ID: NCT07161258
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
12 participants
INTERVENTIONAL
2025-10-06
2029-02-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fenebrutinib
Participants will receive fenebrutinib orally.
Fenebrutinib
Fenebrutinib will be administered orally.
Interventions
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Fenebrutinib
Fenebrutinib will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive
* Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases
Exclusion Criteria
* Co-morbid Conditions:
* Potentially confounding neurological, somatic, or metabolic disorders
* Current clinically significant psychiatric or medical illness
* History of cancer, transplants, or bleeding disorders
* Inability to complete an MRI scan or get gadolinium
* Abnormal liver function tests or blood counts
* Peripheral venous access that precludes venous blood sampling as required per study protocol
* Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets
* Active, recurrent, or chronic infections
* Recent or anticipated use of prohibited medications/treatments:
* Certain disease-modifying therapy (DMT) and other immunosuppressants
* Drugs interacting with fenebrutinib (Cytochrome P450 3A4 \[CYP3A4\] inhibitors)
* Any other investigational therapy, anticoagulants, certain vaccines
10 Years
17 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
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
Countries
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Central Contacts
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Reference Study ID Number: CN45847 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2024-519800-28-00
Identifier Type: CTIS
Identifier Source: secondary_id
CN45847
Identifier Type: -
Identifier Source: org_study_id
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