Phase 3 Study Evaluating Orelabrutinib Compared to Placebo for Treating Non-active Secondary Progressive Multiple Sclerosis

What this Trial Is About

This trial investigates orelabrutinib, a brain-penetrating BTK inhibitor, in patients with non-active Secondary Progressive Multiple Sclerosis SPMS. It is a phase 3, randomized, double-blind, multicenter study comparing the effects and safety of orelabrutinib against a placebo. The study will enroll about 990 participants worldwide, focusing on those with SPMS who have not had recent relapses. Participants will be randomly assigned in a 21 ratio to receive either oral orelabrutinib daily or a placebo. After a screening period of up to 4 weeks, the treatment period will last from approximately 24 to 60 months, with a minimum of 12 months treatment. Those who experience confirmed disability progression may enter a 2-year open-label phase receiving orelabrutinib. A 4-week safety follow-up will occur for those who discontinue treatment before study end or do not enter long-term safety monitoring. During the study, participants will have assessments including disability progression measured over 24 weeks, MRI scans, and various functional tests up to about 120 weeks. Researchers will monitor safety and tolerability throughout. Participants will have a final end-of-study visit within 4 weeks after study completion, with ongoing treatment or follow-up depending on eligibility for long-term safety studies.

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis