drugset / Trial / NCT07161258

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

NCT07161258

Phase 2 Recruiting 12 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-06
Primary completion
2027-06-08
Completion
2029-02-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenebrutinib Small molecule Oral

Indications