Trials / Not Yet Recruiting
Not Yet RecruitingNCT07429266
A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, \& Part 2 long-term extension). Participants may receive treatment for up to 156 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sapablursen | Administered subcutaneously (SC) |
| DRUG | Placebo | Administered SC |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2028-09-01
- Completion
- 2031-01-01
- First posted
- 2026-02-24
- Last updated
- 2026-02-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07429266. Inclusion in this directory is not an endorsement.