A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis (NCT07299019) is a Phase 3 interventional studying Secondary Progressive Multiple Sclerosis, sponsored by Zenas BioPharma (USA), LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Secondary Progressive Multiple Sclerosis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 990 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 18 to 60 years of age, inclusive, at the time of signing the willing to sign a consent form. 2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria 3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 4. 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). 5. Absence of clinical relapses for at least 24 months. Who Should NOT Join This Trial: 1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria 2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy. 3. History or current diagnosis of other neurological disorders that may mimic MS 4. History or current diagnosis of progressive multifocal leukoencephalopathy 5. Active, clinically significant viral, bacterial, or fungal infection 6. History of any other significant active medical condition 7. History of suicidal behavior within 6 months prior to Screening 8. Any prior history of malignancy 9. Patients on anticoagulation, or antiplatelet therapy 10. Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days 11. Clinically significant laboratory abnormalities at Screening. 12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening 13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. 18 to 60 years of age, inclusive, at the time of signing the informed consent. 2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria 3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 4. 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). 5. Absence of clinical relapses for at least 24 months. Exclusion Criteria: 1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria 2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy. 3. History or current diagnosis of other neurological disorders that may mimic MS 4. History or current diagnosis of progressive multifocal leukoencephalopathy 5. Active, clinically significant viral, bacterial, or fungal infection 6. History of any other significant active medical condition 7. History of suicidal behavior within 6 months prior to Screening 8. Any prior history of malignancy 9. Patients on anticoagulation, or antiplatelet therapy 10. Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days 11. Clinically significant laboratory abnormalities at Screening. 12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening 13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Treatments Being Tested

DRUG

Orelabrutinib

Orelabrutinib orally

DRUG

Placebo

Placebo orally

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Perseverance Research Center, LLC (PRC)

Scottsdale, Arizona, United States

Neurology Associates

Maitland, Florida, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Lone Star Neurology

San Antonio, Texas, United States

Texas Institute for Neurological Disorders - Sherman

Sherman, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07299019), the sponsor (Zenas BioPharma (USA), LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07299019 clinical trial studying?

Who can participate in NCT07299019?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07299019?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07299019. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07299019. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.