A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.
• Participants must be phlebotomy-dependent.
• Hct less than (\<) 45% at study start.
• Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.
• Adequate organ function and electrolytes.
Locations
United States
Florida
Regis Clinical Research LLC.
RECRUITING
Miami
Contact Information
Primary
Clinical Team
clinicaltrials@deciphera.com
888-724-3274
Time Frame
Start Date: 2026-05-25
Estimated Completion Date: 2031-01
Participants
Target number of participants: 250
Treatments
Experimental: Sapablursen
Sapablursen (32 Weeks) - Sapablursen (124 Weeks Open-label)
Experimental: Placebo
Placebo (32 Weeks) - Sapablursen (124 Weeks Open-label)
Related Therapeutic Areas
Sponsors
Collaborators: Deciphera Pharmaceuticals, LLC
Leads: Ono Pharmaceutical Co., Ltd.