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

Part of paid clinical trials in Miami, Florida.

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT07429266
Phase
PHASE3
Status
Recruiting
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Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sapablursen — DRUG
    Administered subcutaneously (SC)
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
May 25, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Jan 31, 2031

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sapablursen
    Sapablursen (32 Weeks) - Sapablursen (124 Weeks Open-label)
  • Experimental: Placebo
    Placebo (32 Weeks) - Sapablursen (124 Weeks Open-label)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Regis Clinical Research LLC.MiamiFlorida33126
Roberto Reyes
[email protected]
305-546-3952
Yilena Rodriguez Marrero, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
Regis Clinical Research LLC.· Miami, FL

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