Trials / Recruiting
RecruitingNCT07067463
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 705 (estimated)
- Sponsor
- Zenas BioPharma (USA), LLC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Orelabrutinib | Orally |
| DRUG | Placebo | Orally |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2030-06-01
- Completion
- 2030-07-01
- First posted
- 2025-07-16
- Last updated
- 2025-12-04
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07067463. Inclusion in this directory is not an endorsement.