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NCT07299019 · ClinicalTrials.gov registry record · Phase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
A Phase 3 study of Secondary Progressive Multiple Sclerosis, sponsored by Zenas BioPharma (USA).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 990
- Enrollment target
- 1
- Study location
NCT07299019: Recruiting Phase 3 study of Secondary Progressive Multiple Sclerosis, sponsored by Zenas BioPharma (USA).
NCT07299019 is a Phase 3 study of Secondary Progressive Multiple Sclerosis that is actively recruiting participants, run by Zenas BioPharma (USA). The registered enrollment target is 990 participants, above the 373-participant average among 8 other Secondary Progressive Multiple Sclerosis trials with a reported enrollment target (165% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07299019, a Phase 3 study of Secondary Progressive Multiple Sclerosis, is actively recruiting participants, sponsored by Zenas BioPharma (USA).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 990 participants
- Enrollment target
- 1
- Study location
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.
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Orelabrutinib
Study Locations (1)
Florida
- Neurology Associates - Maitland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 990 participants |
| Start Date | 2026-03 |
| Est. Completion | 2030-07 |
| Phase | Phase 3 |
What NCT07299019 shows while recruiting
NCT07299019 is an interventional study that assigns participants to a tested intervention. The registered 990 participants enrollment target is mid-sized for trials with a published cap, above the 373-participant average among 8 other Secondary Progressive Multiple Sclerosis trials with a reported enrollment target (165% higher).
The record links to 1 condition, with Secondary Progressive Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07299019 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07299019 about?
NCT07299019 is a clinical study titled "A Study of Orelabrutinib in Patients With Secondary 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 non-active Secondary Progress MS. Patients will be treated for approximately 24 ...
What is the current status of trial NCT07299019?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 990 participants. The study started on 2026-03. Estimated completion is 2030-07.
What conditions does trial NCT07299019 study?
This clinical trial studies the following conditions: Secondary Progressive Multiple Sclerosis.
What interventions are being tested in trial NCT07299019?
The interventions under investigation include: Placebo (DRUG), Orelabrutinib (DRUG).
Who is sponsoring clinical trial NCT07299019?
This trial is sponsored by Zenas BioPharma (USA), which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07299019 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Secondary Progressive Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07299019's enrollment target sits among peer trials
990 2nd of 8 the highest of 8 other Secondary Progressive Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Secondary Progressive Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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