INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Ono Pharmaceutical Co., Ltd. · with Deciphera Pharmaceuticals, LLC · NCT07429266
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 250
- US sites recruiting
- 12
- Study start
- May 25, 2026
- Record last updated
- October 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Sapablursen; Placebo
Conditions: Polycythemia Vera
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.
- Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.
- Participants who require phlebotomy at Hct levels \<45%.
- Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.
- Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.
Recruiting US locations
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, CA 93868
Site contact: Kelsey Edwards · 714-509-2705 · kmcabee@hs.uci.edu
Regis Clinical Research LLC.
Miami, FL 33126
Site contact: Roberto Reyes · 305-546-3952 · rreyes@regisclinical.com
Florida Clinical Trials Group
Plantation, FL 33322
Site contact: (772) 297-3057 · harshamin@floridactg.com
Florida Clinical Trials Group
Tamarac, FL 33321
Site contact: Maria Abreu · (772) 297-3057 · abreum@floridactg.com
Central Georgia Cancer Care
Macon, GA 31210
Site contact: Mackenzie Sanders · 4787437068 · mackenzie.sanders@aoncology.com
The Center for Cancer & Blood Disorders
Bethesda, MD 20817
Site contact: Taylor Stutzman · 301-571-0019 · Taylor.Stutzman@aoncology.com
The Cancer and Hematology Centers
Grand Rapids, MI 49503
Site contact: 616-954-9800 · ClinicalTrials@chcwm.com
Montefiore Medical Center
The Bronx, NY 10461
Site contact: Joty Rashid · 718-219-8181 · jorashid@montefiore.org
Gabrail Cancer Center Research
Canton, OH 44718
Site contact: Carrie Smith · 330-417-8231 · csmith@gabrailcancercenter.com
The James Cancer Hospital and Solove Research Institute at The Ohio State University
Columbus, OH 43210
Site contact: Tyler Srail · Tyler.srail@osumc.edu
Fox Chase Cancer Center
Philadelphia, PA 19111
Site contact: Jill Samaha · 215-214-3125 · Jill.Samaha@fccc.edu
Hematology Oncology Associates of Fredericksburg
Fredericksburg, VA 22408
Site contact: Wendy Azucena · Wendy.Azucena@aoncology.com
Study contacts (from the official record)
- Clinical Team · 888-724-3274 · clinicaltrials@deciphera.com