RecruitingPhase 3NCT07067463

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

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

Sponsor

Zenas BioPharma (USA), LLC

Enrollment

705 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis (MS) Primary Progressive

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

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 Criteria12

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.