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

Aug, 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

Locations

Regis Clinical Research LLC.

Recruiting

Miami, Florida, United States, 33126

Contacts

Principal Investigator:

Yilena Rodriguez Marrero, MD

Florida Clinical Trials Group

Recruiting

Plantation, Florida, United States, 33322

Contacts

Principal Investigator:

Harshad Amin, MD

Florida Clinical Trials Group

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Principal Investigator:

Chintan Gandhi, MD

The Center for Cancer & Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Principal Investigator:

Victor M Priego, MD

The Cancer and Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Daniel Foley, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Principal Investigator:

Swati Goel, MD

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718

Contacts

Principal Investigator:

Nashat Y Gabrail, MD

More Information

Sponsor

Ono Pharmaceutical Co., Ltd.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ono Pharmaceutical Co., Ltd. on 2026-08-20.