Roeland Park

Researchers are evaluating the efficacy and safety of orelabrutinib, a brain-penetrating BTK inhibitor, compared to placebo in patients with non-active Secondary Progressive Multiple Sclerosis SPMS. This phase 3, randomized, double-blind, parallel-group, multicenter study aims to enroll approximately 990 participants worldwide, focusing on those with SPMS who have not had recent relapses. The study is sponsored by Zenas BioPharma USA, LLC and will investigate how orelabrutinib affects disability progression in this population. Participants will be randomly assigned in a 21 ratio to receive either oral orelabrutinib once daily or a matching placebo. The study includes several periods up to 4 weeks for screening a treatment period lasting approximately 24 to 60 months depending on enrollment timing a double-blind treatment phase with a minimum of 12 months and an open-label treatment phase of up to 2 years for eligible participants experiencing disability progression. After treatment, a 4-week safety follow-up will occur for those who discontinue early or do not enter the long-term safety study. During the study, participants will undergo assessments to monitor disability progression confirmed over 24 weeks, along with other functional and imaging tests such as MRI lesions and various physical and cognitive performance measures. Researchers will also evaluate safety and tolerability throughout the trial. All participants will have a final study visit near the end date, and ongoing treatment with orelabrutinib may continue for those entering the long-term safety phase. The total participation time varies but includes extensive monitoring over several years.