The Phase 3 clinical trial (NCT04544449) evaluating fenebrutinib for adult participants with Primary Progressive Multiple Sclerosis (PPMS) reached its primary completion on 2025-09-17. This study enrolled 985 participants to assess the efficacy and safety of fenebrutinib compared to ocrelizumab.
Background
Fenebrutinib is being investigated as a potential treatment for Primary Progressive Multiple Sclerosis (PPMS). The trial aims to evaluate its efficacy and safety on disability progression in adult participants with this condition.
Trial design
The study, identified as NCT04544449, is a Phase 3, randomized, blinded clinical trial. It enrolled 985 adult participants globally with Primary Progressive Multiple Sclerosis. Participants were randomized 1:1 to receive either daily oral fenebrutinib (with placebo matched to ocrelizumab) or intravenous ocrelizumab (with placebo matched to fenebrutinib). The study's primary objective is to evaluate the efficacy and safety of fenebrutinib on disability progression.
What this means
The primary completion of this Phase 3 trial signifies that data collection for the main study period has concluded for fenebrutinib in Primary Progressive Multiple Sclerosis. The next steps will involve data analysis and the eventual reporting of results, which will provide crucial insights into the potential role of fenebrutinib as a treatment option for this challenging condition, particularly in comparison to ocrelizumab.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04544449, titled "A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis," was updated to reflect primary completion on 2025-09-17 on clinicaltrials.gov.