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Clinical Trials in Japan / NCT07429266
Recruiting Phase 3

INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)

NCT07429266 · tracked via the Priya Life Science Japan tracker
Sponsor
Ono Pharmaceutical Co., Ltd
Phase
Phase 3
Started
2026-05-25
Last updated
2026-10-05

Condition(s) studied

Polycythemia Vera

Investigational drug(s) / intervention(s)

SapablursenPlacebo

Sapablursen: Administered subcutaneously (SC)

Placebo: Administered SC

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage of Participants with Absence of Phlebotomy Eligibility — Week 20 through Week 32
    Response is defined as absence of phlebotomy eligibility.

Trial sites (17)

FacilityCityRegionStatus
Regis Clinical Research LLC. Miami Florida Recruiting
Florida Clinical Trials Group Plantation Florida Recruiting
Florida Clinical Trials Group Tamarac Florida Recruiting
Central Georgia Cancer Care Macon Georgia Recruiting
The Center for Cancer & Blood Disorders Bethesda Maryland Recruiting
The Cancer and Hematology Centers Grand Rapids Michigan Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Gabrail Cancer Center Research Canton Ohio Recruiting
Perth Blood Institute West Perth Western Australia Recruiting
Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki Japan Recruiting
Osaka Metropolitan University Hospital Osaka Japan Recruiting
Institute of Science Tokyo Hospital Tokyo Japan Recruiting
Tokyo Women's Medical University Hospital Tokyo Japan Recruiting
MICS Centrum Medyczne Torun Torun Poland Recruiting
Royal Devon University Healthcare NHS Foundation Trust Exeter United Kingdom Recruiting
The New Castle upon Tyne Hospital Newcastle upon Tyne United Kingdom Recruiting
Genesis Care Windsor Windsor United Kingdom Recruiting

More Ono Pharmaceutical Co., Ltd. trials in Japan

A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors Active, not recruiting
A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus Recruiting
A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors Active, not recruiting
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma. Recruiting
A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) Active, not recruiting

Other trials for the same condition

A Study of GLB-001 in Patients With Myeloid Malignancies Recruiting
A Study of Rusfertide in Japanese Adults With Polycythemia Vera Recruiting
CINC424A2X01B Rollover Protocol Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07429266 on ClinicalTrials.gov ↗ ← All trials in Japan