Status:
RECRUITING
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
Brief 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 P...
Eligibility Criteria
Inclusion
- A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria and one or more of the following: at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 month
- 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
- A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)
- 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
Key Trial Info
Start Date :
October 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 13 2029
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07161258
Start Date
October 6 2025
End Date
February 13 2029
Last Update
January 9 2026
Active Locations (16)
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1
INECO Neurociencias Orono
Rosario, Santa Fe Province, Argentina, S2000DTB
2
Sanatorio del Sur S.A.
San Miguel de Tucumán, Argentina, T4000IDK
3
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil, 70200-730
4
Instituto de Neurologia de Curitiba - Hospital Ecoville
Curitiba, Paraná, Brazil, 81210-310