NCT07067463 A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
| NCT ID | NCT07067463 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zenas BioPharma (USA), LLC |
| Condition | Multiple Sclerosis (MS) Primary Progressive |
| Study Type | INTERVENTIONAL |
| Enrollment | 705 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 705 participants in total. It began in 2026-03-23 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 18 to 60 years of age, inclusive * Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria * Participant must have documented evidence of disability progression observed during the 24 months before screening. * Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening. Exclusion Criteria: * Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) * Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy. * History or current diagnosis of other neurological disorders that may mimic MS * History of any other significant active medical condition * History of suicidal behavior within 6 months prior to Screening * Any prior history of malignancy if no recurrence within 5 years * Patients on anticoagulation, or antiplatelet therapy will be excluded * Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days * Clinically significant laboratory abnormalities at Screening. * Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07067463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Multiple Sclerosis (MS) Primary Progressive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07067463 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 705 participants.
Is NCT07067463 currently recruiting?
Yes, NCT07067463 is actively recruiting participants. Contact the research team at clinicaltrialsinfo@zenasbio.com for enrollment information.
Where is the NCT07067463 trial being conducted?
This trial is being conducted at Pheonix, United States, Scottsdale, United States, West Hollywood, United States, Bradenton, United States and 11 additional locations.
Who is sponsoring the NCT07067463 clinical trial?
NCT07067463 is sponsored by Zenas BioPharma (USA), LLC. The trial plans to enroll 705 participants.
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