NCT07429266 INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
| NCT ID | NCT07429266 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ono Pharmaceutical Co., Ltd. |
| Condition | Polycythemia Vera |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-05-25 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2026-05-25 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Clinical Team
STUDY DIRECTOR
Deciphera Pharmaceuticals, LLC
Frequently Asked Questions
Who can join the NCT07429266 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Polycythemia Vera. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07429266 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT07429266 currently recruiting?
Yes, NCT07429266 is actively recruiting participants. Contact the research team at clinicaltrials@deciphera.com for enrollment information.
Where is the NCT07429266 trial being conducted?
This trial is being conducted at Miami, United States, Plantation, United States, Tamarac, United States, Macon, United States and 6 additional locations.
Who is sponsoring the NCT07429266 clinical trial?
NCT07429266 is sponsored by Ono Pharmaceutical Co., Ltd.. The principal investigator is Clinical Team at Deciphera Pharmaceuticals, LLC. The trial plans to enroll 250 participants.