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Clinical Trials in Germany / NCT07067463
Recruiting Phase 3

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

NCT07067463 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2026-03-23
Last updated
2026-09-22

Condition(s) studied

Multiple Sclerosis (MS) Primary Progressive

Investigational drug(s) / intervention(s)

Orelabrutinib →Placebo

Orelabrutinib: Orally

Placebo: Orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
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.

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
Arizona Neuroscience Research, LLC Pheonix Arizona Recruiting
Perseverance Research Center Scottsdale Arizona Recruiting
Regina Berkovich MD, PhD Inc. West Hollywood California Recruiting
Nova Clinical Research, LLC Bradenton Florida Recruiting
Neurology Associates, PA Maitland Florida Recruiting
University of South Florida Department of Neurology - MS Division Tampa Florida Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
KC Research Center, PA Neurology Research Department Roeland Park Kansas Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Cooperman Barnabas Medical Center Livingston New Jersey Recruiting
Velocity Clinical Research, Raleigh Neurology Raleigh North Carolina Recruiting
The Ohio State University Wexner Medical Center (OSUWMC) L3-100 Columbus Ohio Recruiting
The Boster Center for Multiple Sclerosis Columbus Ohio Recruiting
Premier Neurology Greenville South Carolina Recruiting
Neurology Clinic, P.C. Cordova Tennessee Recruiting
Lone Star Neurology San Antonio Texas Recruiting
Texas Institute for Neurological Disorders Sherman Texas Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Medical Center Nevrocentrum Plovdiv Plovdiv Recruiting
Diagnostic and Consultative Center Convex Sofia Sofia Recruiting
Avis Medica Hospital Pleven Pleven Bulgaria Recruiting
Medical Center Hera EOOD Sofia Bulgaria Recruiting
Klinicki Bolnicki Centar Zagreb-Rebro Zagreb Croatia Recruiting
NEUROHK, s.r.o. Choceň Czechia Recruiting
Fakultni Nemocnice Hradec Kralove Hradec Králové Czechia Recruiting
Nemocnice Teplice Teplice Czechia Recruiting
Astra Clinic (Clinic4U) Tallinn Harju Recruiting
MD Georgia Staff Physician MediClub Georgia Tbilisi Saburtalo Recruiting
NNLE Jo Ann University Hospital Tbilisi Georgia Recruiting
Caucasus Medical Center Ltd Tbilisi Georgia Recruiting
Raymann, LLC Tbilisi Georgia Recruiting
Neuro Centrum Science Gmbh Albert-Schwitzer Erbach im Odenwald Hesse Recruiting
IRCCS Istituto Neurologico Mediterraneo Neuromed Pozzilli Isemiaa/Molise Recruiting
Zuyderland Medisch Centrum - Sittard-Geleen Sittard Limburg Recruiting
Centrum Medyczne INTERCOR Sp. z o.o. Bydgoszcz Kuyavian-Pomeranian Voivodeship Recruiting
ClinHouse Centrum Medyczne Zabrze Pl-sl Recruiting
NZOZ Novo Med Katowice Silesian Voivodeship Recruiting
Neuro Medic Clinic Katowice Upper Silesia Recruiting
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej Plewiska Wielkopolska Recruiting
Twoja Przychodnia PCM Poznan Wielkopolska Recruiting

+ 25 more sites — see the full list on the official registry below.

More Zenas BioPharma (USA), LLC trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07067463 on ClinicalTrials.gov ↗ ← All trials in Germany