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Secondary Progressive Multiple SclerosisDrugPhase 3

What this study is

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.

What's being tested

  • Orelabrutinib

    Intervention · DRUG

    Orelabrutinib orally

  • Placebo

    Intervention · DRUG

    Placebo orally

Study details

Official title
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
Conditions
Secondary Progressive Multiple Sclerosis
Enrolling
990 people
Starts
2026-03-23
Est. completion
2030-07
Design
Quadruple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗