Study of Fenebrutinib Drug Effects and Safety in Children and Teens With Relapsing Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the pharmacokinetics PK, pharmacodynamic PD effects, safety, and tolerability of fenebrutinib in children and adolescents aged 10 to under 18 years with relapsing multiple sclerosis RMS. This open-label, single-arm Phase 2 study focuses on this specific population to better understand how fenebrutinib behaves in the body and affects disease activity. Participants will receive fenebrutinib orally during the Dose Exploration Period. After completing this period, eligible participants may choose to continue treatment in an Optional Extension Period. The study assesses fenebrutinib plasma concentration up to 96 weeks and monitors new brain lesions through MRI at 12 weeks. Throughout the study, participants will be evaluated for safety and tolerability, including monitoring adverse events, vital signs, ECG parameters, liver function tests, and suicidal ideation using standardized scales. Study assessments and follow-up may last up to approximately 100 weeks, with ongoing data collection on clinical and laboratory measures to understand fenebrutinibs effects in this young population.

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