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NCT07067463 · ClinicalTrials.gov registry record · Phase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis (MS) Primary Progressive, sponsored by Zenas BioPharma (USA).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 705
- Enrollment target
- 2
- Study locations
NCT07067463: Recruiting Phase 3 study of Multiple Sclerosis (MS) Primary Progressive, sponsored by Zenas BioPharma (USA).
NCT07067463 is a Phase 3 study of Multiple Sclerosis (MS) Primary Progressive that is actively recruiting participants, run by Zenas BioPharma (USA). The registered enrollment target is 705 participants, above the 138-participant average among 3 other Multiple Sclerosis (MS) Primary Progressive trials with a reported enrollment target (411% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07067463, a Phase 3 study of Multiple Sclerosis (MS) Primary Progressive, is actively recruiting participants, sponsored by Zenas BioPharma (USA).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 705 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
* 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)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Orelabrutinib
Study Locations (2)
Florida
- Neurology Associates, PA - Maitland
South Carolina
- Premier Neurology - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 705 participants |
| Start Date | 2025-12 |
| Est. Completion | 2030-07 |
| Phase | Phase 3 |
What NCT07067463 shows while recruiting
NCT07067463 is an interventional study that assigns participants to a tested intervention. The registered 705 participants enrollment target is mid-sized for trials with a published cap, above the 138-participant average among 3 other Multiple Sclerosis (MS) Primary Progressive trials with a reported enrollment target (411% higher).
The record links to 1 condition, with Multiple Sclerosis (MS) Primary Progressive appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07067463 reports a single indexed study location in Florida, South Carolina.
Frequently Asked Questions
What is clinical trial NCT07067463 about?
NCT07067463 is a clinical study titled "A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis". 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...
What is the current status of trial NCT07067463?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 705 participants. The study started on 2025-12. Estimated completion is 2030-07.
What conditions does trial NCT07067463 study?
This clinical trial studies the following conditions: Multiple Sclerosis (MS) Primary Progressive.
What interventions are being tested in trial NCT07067463?
The interventions under investigation include: Placebo (DRUG), Orelabrutinib (DRUG).
Who is sponsoring clinical trial NCT07067463?
This trial is sponsored by Zenas BioPharma (USA), which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07067463 being conducted?
This trial has 2 study locations across Florida, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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