A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis (MS) Primary Progressive

In brief

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.

Key facts

Study ID

NCT07067463

Run by

Zenas BioPharma (USA), LLC

People needed

705

Starts

2026-03-23

Expected to finish

2030-07-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Neuroscience Research, LLC — Pheonix, Arizona, United States (enrolling)
• Perseverance Research Center — Scottsdale, Arizona, United States (enrolling)
• Regina Berkovich MD, PhD Inc. — West Hollywood, California, United States (enrolling)
• Nova Clinical Research, LLC — Bradenton, Florida, United States (enrolling)
• Neurology Associates, PA — Maitland, Florida, United States (enrolling)
• KC Research Center, PA Neurology Research Department — Roeland Park, Kansas, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Cooperman Barnabas Medical Center — Livingston, New Jersey, United States (enrolling)
• Velocity Clinical Research, Raleigh Neurology — Raleigh, North Carolina, United States (enrolling)
• The Boster Center for Multiple Sclerosis — Columbus, Ohio, United States (enrolling)
• Premier Neurology — Greenville, South Carolina, United States (enrolling)
• Neurology Clinic, P.C. — Cordova, Tennessee, United States (enrolling)
• Lone Star Neurology — San Antonio, Texas, United States (enrolling)
• Texas Institute for Neurological Disorders — Sherman, Texas, United States (enrolling)
• Medical Center Nevrocentrum — Plovdiv, Plovdiv, Bulgaria (enrolling)
• Diagnostic and Consultative Center Convex — Sofia, Sofia, Bulgaria (enrolling)
• Avis Medica Hospital Pleven — Pleven, Bulgaria (enrolling)
• Klinicki Bolnicki Centar Zagreb-Rebro — Zagreb, Croatia (enrolling)
• NEUROHK, s.r.o. — Choceň, Czechia (enrolling)
• Astra Clinic (Clinic4U) — Tallinn, Harju, Estonia (enrolling)
• MD Georgia Staff Physician MediClub Georgia — Tbilisi, Saburtalo, Georgia (enrolling)
• NNLE Jo Ann University Hospital — Tbilisi, Georgia (enrolling)
• Raymann, LLC — Tbilisi, Georgia (enrolling)
• Neuro Centrum Science Gmbh Albert-Schwitzer — Erbach im Odenwald, Hesse, Germany (enrolling)
• IRCCS Istituto Neurologico Mediterraneo Neuromed — Pozzilli, Isemiaa/Molise, Italy (enrolling)

Full record on ClinicalTrials.gov

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