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Phase 3Recruiting

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis

Sponsor
Zenas BioPharma (USA), LLC (Industry)
Enrolment
990 planned
Conditions
Secondary Progressive Multiple Sclerosis
Interventions
Orelabrutinib; Placebo
Ages
adults
Registry
NCT07299019

Full record on ClinicalTrials.gov

From the registry

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

Primary outcomes

  • Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered