Sapablursen added to standard care for people with polycythemia vera

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Sapablursen is being tested as an add-on to current standard of care in adults with phlebotomy-dependent polycythemia vera. The phase 3 program is organized in three sequential parts: a blinded treatment period (Part 1a) comparing sapablursen to placebo, an open-label treatment period (Part 1b), and a long-term extension (Part 2) with up to 156 weeks of exposure. Eligible participants must meet the 2022 WHO and ICC diagnostic criteria for PV, be phlebotomy-dependent with baseline hematocrit <45%, and may remain on a stable cytoreductive regimen. Outcomes focus on hematocrit control, need for phlebotomy, and safety monitoring including thrombotic events and other adverse effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC Irvine Health - Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting
• Regis Clinical Research LLC.
  Miami, Florida, United States Recruiting
• Florida Clinical Trials Group
  Plantation, Florida, United States Recruiting
• Florida Clinical Trials Group
  Tamarac, Florida, United States Recruiting
• Central Georgia Cancer Care
  Macon, Georgia, United States Recruiting
• The Center for Cancer & Blood Disorders
  Bethesda, Maryland, United States Recruiting

Study contacts

• Study coordinator: Clinical Team
• Email: clinicaltrials@deciphera.com
• Phone: 888-724-3274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.