A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Public ClinicalTrials.gov record NCT07299019. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07299019
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 990 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 23, 2026 (Actual)
- Primary completion
- Jun 2030 (Estimated)
- Completion
- Jul 2030 (Estimated)
- Last update posted
- Oct 21, 2026
2026 – 2030
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Neuroscience Research, LLC | Phoenix | Arizona | 85032 | Recruiting |
| Perseverance Research Center, LLC (PRC) | Scottsdale | Arizona | 85253 | Recruiting |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | Recruiting |
| Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)) | Torrance | California | 90502-2006 | Recruiting |
| Regina Berkovich MD, PhD Inc | West Hollywood | California | 90048 | Recruiting |
| SFM Clinical Research, LLC | Boca Raton | Florida | 33487 | Recruiting |
| Nova Clinical Research, LLC | Bradenton | Florida | 34209 | Recruiting |
| MS and Neuromuscular Center of Excellence | Clearwater | Florida | 33761 | Recruiting |
| Neurology Associates | Maitland | Florida | 32751 | Recruiting |
| Aqualane Clinical Research | Naples | Florida | 34105 | Recruiting |
| University of South Florida Department of Neurology - MS Division | Tampa | Florida | 33612 | Recruiting |
| Josephson Wallack Munshower Neurology, Pc Suite 225 | Indianapolis | Indiana | 46256 | Recruiting |
| KC Research Center, PA Neurology Research Dept | Roeland Park | Kansas | 66205 | Recruiting |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | Withdrawn |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | Recruiting |
| Profound Research LLC at Oakland Neurology Center | Rochester Hills | Michigan | 48307 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| University Of New Mexico School Of Medicine | Albuquerque | New Mexico | 87131 | Recruiting |
| Mount Sinai Medical Center | New York | New York | 10029 | Recruiting |
| The Ohio State University Wexner Medical Center (OSUWMC) | Columbus | Ohio | 43221 | Recruiting |
| The Boster Center for Multiple Sclerosis | Columbus | Ohio | 43235 | Recruiting |
| OMRF Multiple Sclerosis Center of Excellence | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Premier Neurology | Greenville | South Carolina | 29605 | Recruiting |
| Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | Recruiting |
| Lone Star Neurology | San Antonio | Texas | 78258 | Recruiting |
| Texas Institute for Neurological Disorders - Sherman | Sherman | Texas | 75092 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07299019, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 21, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07299019 live on ClinicalTrials.gov.