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A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
12 patients around the world
Available in Brazil
Hoffmann-La Roche
1Research sites
12Patients around the world
This study is for people with
Multiple Sclerosis
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.
- A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS).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.
Sites
Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS
Recruiting
StudyFENerations1
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Multiple Sclerosis
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07161258
