A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
Orelabrutinib: Orelabrutinib orally
Placebo: 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 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
Primary outcome measure(s)
- Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks — Up to approximately 120 weeks
Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0
Trial sites (90)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Neuroscience Research, LLC | Phoenix | Arizona | Recruiting |
| Perseverance Research Center, LLC (PRC) | Scottsdale | Arizona | Recruiting |
| Fullerton Neurology and Headache Center | Fullerton | California | Recruiting |
| Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)) | Torrance | California | Recruiting |
| Regina Berkovich MD, PhD Inc | West Hollywood | California | Recruiting |
| SFM Clinical Research, LLC | Boca Raton | Florida | Recruiting |
| Nova Clinical Research, LLC | Bradenton | Florida | Recruiting |
| MS and Neuromuscular Center of Excellence | Clearwater | Florida | Recruiting |
| Neurology Associates | Maitland | Florida | Recruiting |
| Aqualane Clinical Research | Naples | Florida | Recruiting |
| University of South Florida Department of Neurology - MS Division | Tampa | Florida | Recruiting |
| Josephson Wallack Munshower Neurology, Pc Suite 225 | Indianapolis | Indiana | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| KC Research Center, PA Neurology Research Dept | Roeland Park | Kansas | Recruiting |
| Boston Clinical Trials | Boston | Massachusetts | Withdrawn |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | Recruiting |
| Profound Research LLC at Oakland Neurology Center | Rochester Hills | Michigan | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| University Of New Mexico School Of Medicine | Albuquerque | New Mexico | Recruiting |
| Mount Sinai Medical Center | New York | New York | Recruiting |
| The Ohio State University Wexner Medical Center (OSUWMC) | Columbus | Ohio | Recruiting |
| The Boster Center for Multiple Sclerosis | Columbus | Ohio | Recruiting |
| OMRF Multiple Sclerosis Center of Excellence | Oklahoma City | Oklahoma | 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 | Sherman | Texas | Recruiting |
| Southern Neurology Suite 2 | Kogarah | New South Wales | Recruiting |
| MS-Netwerk Limburg - Revalidatie | Overpelt | Limburg | Recruiting |
| Medical Center Nevrocentrum | Plovdiv | Plovdiv | Recruiting |
| Medical Center Hera EOOD | Sofia | Sofia | Recruiting |
| Diagnostic and Consultative Center Convex | Sofia | Sofia | Recruiting |
| Medical Center Medica Plus OOD | Veliko Tarnovo | Tarnovo | Recruiting |
| Avis Medica Hospital Pleven | Pleven | Bulgaria | Recruiting |
| Klinicki Bolnicki Centar Zagreb-Rebro | Zagreb | Croatia | Recruiting |
| NEUROHK, s.r.o. | Choceň | Czechia | Recruiting |
| Regional Hospital Jihlava | Jihlava | Czechia | Recruiting |
| Astra clinic (Clinic4U) | Tallinn | Harju | Recruiting |
| Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau | Nîmes | Gard | Recruiting |
| JSC Curatio | Tbilisi | K'alak'i T'bilisi | Recruiting |
+ 50 more sites — see the full list on the official registry below.
More Zenas BioPharma (USA), LLC trials in the USA
Other trials for the same condition
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 NCT07299019 on ClinicalTrials.gov ↗ ← All trials in the USA