NCT07429266PHASE3Recruiting
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Ono Pharmaceutical Co., Ltd.
Start Date
5/25/2026
Completion Date
1/1/2031
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 Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.
2. Participants must be phlebotomy-dependent.
3. Hct less than (\<) 45% at study start.
4. Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.
5. Adequate organ function and electrolytes.
Exclusion Criteria:
1. Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.
2. Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.
3. Participants who require phlebotomy at Hct levels \<45%.
4. Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.
5. Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.
Interventions
DRUG
Sapablursen
DRUG
Placebo
Conditions
Polycythemia Vera
Locations
Regis Clinical Research LLC.
Miami, Florida 33126
United States
Florida Clinical Trials Group
Plantation, Florida 33322
United States
Florida Clinical Trials Group
Tamarac, Florida 33321
United States
The Center for Cancer & Blood Disorders
Bethesda, Maryland 20817
United States
Montefiore Medical Center
The Bronx, New York 10461
United States
Gabrail Cancer Center Research
Canton, Ohio 44718
United States