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A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Autoimmune Disorder Multiple Sclerosis (MS) Relapsing Multiple Sclerosis (RMS)
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Study Identifier
NCT07161258, CN45847, 2024-519800-28-00
Condition
Relapsing Multiple Sclerosis
Official Title
An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis
Study 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 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.
Eligibility Criteria
All
≥10 Years & ≤ 17 Years
No
Inclusion Criteria
- 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 Criteria
- 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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com