RecruitingPhase 3NCT07299019

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

Sponsor

Zenas BioPharma (USA), LLC

Enrollment

990 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Secondary Progressive Multiple Sclerosis

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 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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

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 Criteria13

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.