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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Orelabrutinib Group
  • Drug: Orelabrutinib
    Orally
Placebo Comparator
Placebo Group
  • Drug: Placebo
    Orally

Recruiting Locations

Arizona Neuroscience Research, LLC
Pheonix, Arizona 85032

Perseverance Research Center
Scottsdale, Arizona 85253

Regina Berkovich MD, PhD Inc.
West Hollywood, California 90048

Nova Clinical Research, LLC
Bradenton, Florida 34209

Neurology Associates, PA
Maitland, Florida 32751

KC Research Center, PA Neurology Research Department
Roeland Park, Kansas 66205

Washington University School of Medicine
St Louis, Missouri 63110

Velocity Clinical Research, Raleigh Neurology
Raleigh, North Carolina 27607

The Boster Center for Multiple Sclerosis
Columbus, Ohio 43235

Premier Neurology
Greenville, South Carolina 29605

Neurology Clinic, P.C.
Cordova, Tennessee 38018

Lone Star Neurology
San Antonio, Texas 78258

Texas Institute for Neurological Disorders
Sherman, Texas 75092

More Details

Status
Recruiting
Sponsor
Zenas BioPharma (USA), LLC

Study Contact

Patient and Medical Information
833-269-4696
clinicaltrialsinfo@zenasbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.