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Study identifier: NCT07299019 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

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

PhasePhase 3
Planned participants990
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 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.

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

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

Always discuss trial participation with your own doctor first.

Locations (20)

Arizona Neuroscience Research, LLCPhoenix, Arizona, United StatesRecruiting
Perseverance Research Center, LLC (PRC)Scottsdale, Arizona, United StatesRecruiting
Fullerton Neurology and Headache CenterFullerton, California, United StatesRecruiting
Regina Berkovich MD, PhD IncWest Hollywood, California, United StatesRecruiting
SFM Clinical Research, LLCBoca Raton, Florida, United StatesRecruiting
Nova Clinical Research, LLCBradenton, Florida, United StatesRecruiting
MS and Neuromuscular Center of ExcellenceClearwater, Florida, United StatesRecruiting
Neurology AssociatesMaitland, Florida, United StatesRecruiting
Aqualane Clinical ResearchNaples, Florida, United StatesRecruiting
Josephson Wallack Munshower Neurology, Pc Suite 225Indianapolis, Indiana, United StatesRecruiting
KC Research Center, PA Neurology Research DeptRoeland Park, Kansas, United StatesRecruiting
Boston Clinical TrialsBoston, Massachusetts, United StatesWithdrawn

+ 8 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07299019