Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07429266

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Polycythemia Vera Bone Marrow Diseases Bone Marrow Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Regis Clinical Research LLC., Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sapablursen

Drug

Administered subcutaneously (SC)

Other names: ONO-0530, ISIS 702843

Placebo

Drug

Administered SC

Primary outcomes

  1. Percentage of Participants with Absence of Phlebotomy Eligibility

    Time frame: Week 20 through Week 32

    Response is defined as absence of phlebotomy eligibility.

Secondary outcomes

  1. Number of Phlebotomies

    Time frame: Week 0 through Week 32

  2. Percentage of Participants with Hct Control

    Time frame: Week 0 to Week 32

    Defined as all local laboratory Hct <45% without phlebotomy.

  3. Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Total T-score

    Time frame: Baseline, Week 32

  4. Change from Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS)

    Time frame: Baseline, Week 32

  5. Percentage of Participants with Absence of Phlebotomy Eligibility

    Time frame: Week 20 through Week 52

    Response is defined as absence of phlebotomy eligibility.

  6. Number of Phlebotomies

    Time frame: Week 0 through Week 52

  7. Percentage of Participants with Hct Control

    Time frame: Week 0 through Week 52

    Defined as all local laboratory Hct <45% without phlebotomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Team

CONTACT

[email protected]

888-724-3274

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Deciphera Pharmaceuticals, LLC

Registry information

Official study title

A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

Acronym: INTREPID

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Feb 24, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.