Tests fenebrutinib in young people with relapsing multiple sclerosis
Tests fenebrutinib in young people with relapsing multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Key facts
- Where
- Brasília, Curitiba, Porto Alegre, and São Paulo, BrazilSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT07161258, who can take part
Where in Brazil
- L2IP - Instituto de Pesquisas Clínicas LtdaBrasília, BrazilTaking people
- Instituto de Neurologia de Curitiba - Hospital EcovilleCuritiba, BrazilTaking people
- Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCRPorto Alegre, BrazilTaking people
- Centro de Pesquisas Clinicas - CPCLINSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07161258EU 2024-519800-28-00
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis
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.
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: Recent or anticipated use of prohibited medications/treatments:; Drugs interacting with fenebrutinib (Cytochrome P450 3A4 [CYP3A4] inhibitors); Any other investigational therapy, anticoagulants, certain vaccines; Co-morbid Conditions:; Potentially confounding neurological, somatic, or metabolic disorders; Current clinically significant psychiatric or medical illness; History of cancer, transplants, or bleeding disorders; Active, recurrent, or chronic infections; Certain disease-modifying therapy (DMT) and other immunosuppressants; Abnormal liver function tests or blood counts; A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS); Inability to complete an MRI scan or get gadolinium; Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets; A score of 4 or 5 on the "last 6 months" section of the screening SI section or "yes" on any item of the "last 6 months" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment.