Clinical Trial

A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)

Study acronym: FENerations1
Recruiting Phase 2
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2025-09-01; most recent amendment 2026-07-08.
Trial Details
NCT Number NCT07161258
Lead Sponsor Hoffmann-La Roche
Conditions Relapsing Multiple Sclerosis
Enrollment 12 participants
Start Date 2025-10-06
Primary Completion 2027-06-08 (estimated)
Study Completion 2029-02-13 (estimated)
Updated on ClinicalTrials.gov 2026-08-11