Recruiting
Phase 3

Sapablursen

Sponsor:

Ono Pharmaceutical Co., Ltd.

Code:

NCT07429266

Conditions

Polycythemia Vera

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sapablursen

Placebo

Study Details

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.

Conditions

Polycythemia Vera

Study ID

NCT07429266

Start date

May 25, 2026

Status verified date

Oct, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sapablursen

Sapablursen (32 Weeks) - Sapablursen (124 Weeks Open-label)

experimental: Placebo

Placebo (32 Weeks) - Sapablursen (124 Weeks Open-label)

Interventions

Sapablursen

Administered subcutaneously (SC)

Placebo

Administered SC

Primary outcome measure

  • Percentage of Participants with Absence of Phlebotomy Eligibility [ Time Frame: Week 20 through Week 32 ]

Central Contacts and Locations

Central contacts

Clinical Team

888-724-3274clinicaltrials@deciphera.com

Locations

UC Irvine Health - Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 93868

Contacts

Kelsey Edwards

714-509-2705kmcabee@hs.uci.edu

Principal Investigator:

Angela Fleischman, MD

Regis Clinical Research LLC.

Recruiting

Miami, Florida, United States, 33126

Contacts

Roberto Reyes

305-546-3952rreyes@regisclinical.com

Principal Investigator:

Yilena Rodriguez Marrero, MD

Florida Clinical Trials Group

Recruiting

Plantation, Florida, United States, 33322

Contacts

(772) 297-3057harshamin@floridactg.com

Principal Investigator:

Harshad Amin, MD

Florida Clinical Trials Group

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Maria Abreu

(772) 297-3057abreum@floridactg.com

Principal Investigator:

Chintan Gandhi, MD

Central Georgia Cancer Care

Recruiting

Macon, Georgia, United States, 31210

Contacts

Mackenzie Sanders

4787437068mackenzie.sanders@aoncology.com

Principal Investigator:

Bradley Sumrall, MD

The Center for Cancer & Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Taylor Stutzman

301-571-0019Taylor.Stutzman@aoncology.com

Principal Investigator:

Victor M Priego, MD

The Cancer and Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

616-954-9800ClinicalTrials@chcwm.com

Principal Investigator:

Daniel Foley, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Joty Rashid

718-219-8181jorashid@montefiore.org

Principal Investigator:

Swati Goel, MD

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718

Contacts

Carrie Smith

330-417-8231csmith@gabrailcancercenter.com

Principal Investigator:

Nashat Y Gabrail, MD

The James Cancer Hospital and Solove Research Institute at The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Tyler Srail

Tyler.srail@osumc.edu

Principal Investigator:

Jennifer Vaughn, MD

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Jill Samaha

215-214-3125Jill.Samaha@fccc.edu

Principal Investigator:

Iberia Sosa, MD

Hematology Oncology Associates of Fredericksburg

Recruiting

Fredericksburg, Virginia, United States, 22408

Contacts

Wendy Azucena

Wendy.Azucena@aoncology.com

Principal Investigator:

Lakshminarayanan Nandagopal, MD

More Information

Sponsor

Ono Pharmaceutical Co., Ltd.

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Ono Pharmaceutical Co., Ltd. on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.