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Study identifier: NCT07067463 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Condition: Multiple Sclerosis (MS) Primary Progressive  ·  Sponsor: Zenas BioPharma (USA), LLC

PhasePhase 3
Planned participants705
Who can joinAll sexes, 18 Years to 60 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Patient and Medical Information  ·  833-269-4696  ·  clinicaltrialsinfo@zenasbio.com

Always discuss trial participation with your own doctor first.

Locations (40)

Arizona Neuroscience Research, LLCPheonix, Arizona, United StatesRecruiting
Perseverance Research CenterScottsdale, Arizona, United StatesRecruiting
Regina Berkovich MD, PhD Inc.West Hollywood, California, United StatesRecruiting
Nova Clinical Research, LLCBradenton, Florida, United StatesRecruiting
Neurology Associates, PAMaitland, Florida, United StatesRecruiting
KC Research Center, PA Neurology Research DepartmentRoeland Park, Kansas, United StatesRecruiting
Washington University School of MedicineSt Louis, Missouri, United StatesRecruiting
Cooperman Barnabas Medical CenterLivingston, New Jersey, United StatesRecruiting
Velocity Clinical Research, Raleigh NeurologyRaleigh, North Carolina, United StatesRecruiting
The Boster Center for Multiple SclerosisColumbus, Ohio, United StatesRecruiting
Premier NeurologyGreenville, South Carolina, United StatesRecruiting
Neurology Clinic, P.C.Cordova, Tennessee, United StatesRecruiting

+ 28 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07067463