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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sapablursen 		Sapablursen (32 Weeks) - Sapablursen (124 Weeks Open-label)
  • Drug: Sapablursen
    Administered subcutaneously (SC)
    Other names:
    • ONO-0530
    • ISIS 702843
Experimental
Placebo 		Placebo (32 Weeks) - Sapablursen (124 Weeks Open-label)
  • Drug: Sapablursen
    Administered subcutaneously (SC)
    Other names:
    • ONO-0530
    • ISIS 702843
  • Drug: Placebo
    Administered SC

Recruiting Locations

Regis Clinical Research LLC.
Miami, Florida 33126
Contact:
Roberto Reyes
305-546-3952
rreyes@regisclinical.com

More Details

Status
Recruiting
Sponsor
Ono Pharmaceutical Co., Ltd.

Study Contact

Clinical Team
888-724-3274
clinicaltrials@deciphera.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.