A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP) — 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, OR * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-hole Peg Test (9HPT)
Trial sites (67)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| University G. D'Annunzio of Chieti-Pescara | Chieti | Italy | 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 |
+ 27 more sites — see the full list on the official registry below.
More Zenas BioPharma (USA), LLC trials in Spain
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 Spain