A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Secondary Progressive Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT07299019

Run by

Zenas BioPharma (USA), LLC

People needed

990

Starts

2026-03-23

Expected to finish

2030-07-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 60 years of age, inclusive, at the time of signing the informed consent.
• Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
• Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
• Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).
• Absence of clinical relapses for at least 24 months.

You may not qualify if…

• The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
• Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
• History or current diagnosis of other neurological disorders that may mimic MS
• History or current diagnosis of progressive multifocal leukoencephalopathy
• Active, clinically significant viral, bacterial, or fungal infection
• History of any other significant active medical condition
• History of suicidal behavior within 6 months prior to Screening
• Any prior history of malignancy
• Patients on anticoagulation, or antiplatelet therapy
• Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days
• Clinically significant laboratory abnormalities at Screening.
• Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
• History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Where it is running

• University Clinical Centre of Kragujevac — Kragujevac, Serbia (enrolling)
• Perseverance Research Center, LLC (PRC) — Scottsdale, Arizona, United States (enrolling)
• Fullerton Neurology and Headache Center — Fullerton, California, United States (enrolling)
• Regina Berkovich MD, PhD Inc — West Hollywood, California, United States (enrolling)
• SFM Clinical Research, LLC — Boca Raton, Florida, United States (enrolling)
• Nova Clinical Research, LLC — Bradenton, Florida, United States (enrolling)
• MS and Neuromuscular Center of Excellence — Clearwater, Florida, United States (enrolling)
• Neurology Associates — Maitland, Florida, United States (enrolling)
• Aqualane Clinical Research — Naples, Florida, United States (enrolling)
• Josephson Wallack Munshower Neurology, Pc Suite 225 — Indianapolis, Indiana, United States (enrolling)
• KC Research Center, PA Neurology Research Dept — Roeland Park, Kansas, United States (enrolling)
• Arizona Neuroscience Research, LLC — Phoenix, Arizona, United States (enrolling)
• Profound Research LLC at Oakland Neurology Center — Rochester Hills, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• The Boster Center for Multiple Sclerosis — Columbus, Ohio, United States (enrolling)
• OMRF Multiple Sclerosis Center of Excellence — Oklahoma City, Oklahoma, United States (enrolling)
• Premier Neurology — Greenville, South Carolina, United States (enrolling)
• Lone Star Neurology — San Antonio, Texas, United States (enrolling)
• Texas Institute for Neurological Disorders - Sherman — Sherman, Texas, United States (enrolling)
• Twoja Przychodnia Centrum Medyczne Nowa Sól — Nowa Sól, Lubusz Voivodeship, Poland (enrolling)
• Nmedis sp. z o.o. — Rzeszów, Rzeszów, Poland (enrolling)
• NZOZ Novo Med — Katowice, Silesian Voivodeship, Poland (enrolling)
• MA-LEK Clinical Sp. z o.o. — Katowice, Poland (enrolling)
• Galen Clinic — Lublin, Poland (enrolling)
• Zanamed Medical Clinic Sp.z o.o. — Lublin, Poland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.