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RECRUITING
NCT07067463
PHASE3

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Sponsor: Zenas BioPharma (USA), LLC

View on ClinicalTrials.gov

Summary

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 PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

Official title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

705

Start Date

2025-12

Completion Date

2030-07

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orally

DRUG

Placebo

Orally

Locations (2)

Neurology Associates, PA

Maitland, Florida, United States

Premier Neurology

Greenville, South Carolina, United States