A new phase 2 trial is testing fenebrutinib, an oral BTK inhibitor, in children and teens with relapsing multiple sclerosis. The FENerations1 study aims to establish the right dose for kids aged 10–17, a group with few approved treatment options. Adult trial data showed strong efficacy, and the FDA is now reviewing the drug under priority review.
A phase 2 clinical trial called FENerations1 is now enrolling children and adolescents aged 10–17 with relapsing multiple sclerosis (RMS) to evaluate fenebrutinib, an investigational oral Bruton tyrosine kinase (BTK) inhibitor developed by Roche. The open-label, single-arm study aims to enroll 8–12 participants through a 12-week dose-exploration period, with an optional 96-week extension. The study is being presented at the 10th Joint ACTRIMS-ECTRIMS Meeting in Toronto.
Pediatric-onset MS is known for high disease activity and frequent relapses, yet relatively few disease-modifying therapies are approved for this age group. The trial's two coprimary endpoints focus on drug exposure (plasma concentration) and MRI activity (new T1 gadolinium-enhancing lesions), with no efficacy or safety results reported yet.
By the Numbers
Why it matters: With strong adult efficacy data and FDA priority review underway, establishing a safe and effective pediatric dose could open the door to a high-efficacy treatment option for a vulnerable patient population that currently has limited choices.
