A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Public ClinicalTrials.gov record NCT07067463. 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 Primary 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 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.
Study identification
- NCT ID
- NCT07067463
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 705 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 22, 2026
- Primary completion
- May 31, 2030
- Completion
- Jun 30, 2030
- Last update posted
- Sep 9, 2026
2026 – 2030
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Neuroscience Research, LLC | Pheonix | Arizona | 85032 | Recruiting |
| Perseverance Research Center | Scottsdale | Arizona | 85253 | Recruiting |
| Regina Berkovich MD, PhD Inc. | West Hollywood | California | 90048 | Recruiting |
| Nova Clinical Research, LLC | Bradenton | Florida | 34209 | Recruiting |
| Neurology Associates, PA | Maitland | Florida | 32751 | Recruiting |
| KC Research Center, PA Neurology Research Department | Roeland Park | Kansas | 66205 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | Recruiting |
| Velocity Clinical Research, Raleigh Neurology | Raleigh | North Carolina | 27607 | Recruiting |
| The Ohio State University Wexner Medical Center (OSUWMC) L3-100 | Columbus | Ohio | 43221 | Recruiting |
| The Boster Center for Multiple Sclerosis | Columbus | Ohio | 43235 | 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 | Texas | 75092 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | 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 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07067463, 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 Sep 9, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07067463 live on ClinicalTrials.gov.