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
Apply to this trial

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

First listed
Feb 24, 2026
Start date
May 25, 2026
Status verified
Jul 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 (6)

FacilityCityStateZIPSite coordinators
Regis Clinical Research LLC.MiamiFlorida33126
Roberto Reyes
[email protected]
305-546-3952
Yilena Rodriguez Marrero, MD (PRINCIPAL_INVESTIGATOR)
Florida Clinical Trials GroupPlantationFlorida33322
[email protected]
(772) 297-3057
Harshad Amin, MD (PRINCIPAL_INVESTIGATOR)
Florida Clinical Trials GroupTamaracFlorida33321
Maria Abreu
[email protected]
(772) 297-3057
Chintan Gandhi, MD (PRINCIPAL_INVESTIGATOR)
The Center for Cancer & Blood DisordersBethesdaMaryland20817
Taylor Stutzman
[email protected]
301-571-0019
Victor M Priego, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10461
Joty Rashid
[email protected]
718-219-8181
Swati Goel, MD (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer Center ResearchCantonOhio44718
Carrie Smith
[email protected]
330-417-8231
Nashat Y Gabrail, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
Regis Clinical Research LLC.· Miami, FLFlorida Clinical Trials Group· Plantation, FLFlorida Clinical Trials Group· Tamarac, FLThe Center for Cancer & Blood Disorders· Bethesda, MDMontefiore Medical Center· The Bronx, NYGabrail Cancer Center Research· Canton, OH

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