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A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

RecruitingPhase 3

Sponsor: Zenas BioPharma (USA), LLC

Conditions: Secondary Progressive Multiple Sclerosis

Interventions: Orelabrutinib, Placebo

Countries: United States, Poland

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (20)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Fullerton, California, United States
West Hollywood, California, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Clearwater, Florida, United States
Maitland, Florida, United States
Naples, Florida, United States
Indianapolis, Indiana, United States
Roeland Park, Kansas, United States
Boston, Massachusetts, United States
Rochester Hills, Michigan, United States
St Louis, Missouri, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Greenville, South Carolina, United States
San Antonio, Texas, United States
Sherman, Texas, United States
Rzeszów, Rzeszów, Poland