NCT07299019 · Zenas BioPharma (USA), LLC
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
What this study is about
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomly assigned, where neither patients nor doctors know which treatment is given, parallel-group, conducted at multiple hospitals study to evaluate the effectiveness and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Phoenix, Arizona
- Scottsdale, Arizona
- Fullerton, California
- West Hollywood, California
- Bradenton, Florida
- Maitland, Florida
- Roeland Park, Kansas
- Boston, Massachusetts
- Rochester Hills, Michigan
- St Louis, Missouri
- Columbus, Ohio
- San Antonio, Texas
And 1 more location — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations