Recruiting
Phase 3

Orelabrutinib

Sponsor:

Zenas BioPharma (USA), LLC

Code:

NCT07067463

Conditions

Multiple Sclerosis (MS) Primary Progressive

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Orelabrutinib

Placebo

Study Details

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.

Conditions

Multiple Sclerosis (MS) Primary Progressive

Study ID

NCT07067463

Start date

Mar 23, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

705 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orelabrutinib Group

placebo comparator: Placebo Group

Interventions

Orelabrutinib

Orally

Placebo

Orally

Primary outcome measure

  • Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP) [ Time Frame: Up to approximately 120 weeks ]

Central Contacts and Locations

Central contacts

Patient and Medical Information

833-269-4696clinicaltrialsinfo@zenasbio.com

Locations

Arizona Neuroscience Research, LLC

Recruiting

Pheonix, Arizona, United States, 85032

Perseverance Research Center

Recruiting

Scottsdale, Arizona, United States, 85253

Regina Berkovich MD, PhD Inc.

Recruiting

West Hollywood, California, United States, 90048

Nova Clinical Research, LLC

Recruiting

Bradenton, Florida, United States, 34209

Neurology Associates, PA

Recruiting

Maitland, Florida, United States, 32751

KC Research Center, PA Neurology Research Department

Recruiting

Roeland Park, Kansas, United States, 66205

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Cooperman Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 07039

Velocity Clinical Research, Raleigh Neurology

Recruiting

Raleigh, North Carolina, United States, 27607

The Ohio State University Wexner Medical Center (OSUWMC) L3-100

Recruiting

Columbus, Ohio, United States, 43221

The Boster Center for Multiple Sclerosis

Recruiting

Columbus, Ohio, United States, 43235

Premier Neurology

Recruiting

Greenville, South Carolina, United States, 29605

Neurology Clinic, P.C.

Recruiting

Cordova, Tennessee, United States, 38018

Lone Star Neurology

Recruiting

San Antonio, Texas, United States, 78258

Texas Institute for Neurological Disorders

Recruiting

Sherman, Texas, United States, 75092

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Zenas BioPharma (USA), LLC

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Zenas BioPharma (USA), LLC on 2026-09-04.