The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the
frequency of phlebotomy and in improving quality of life assessments in participants with
polycythemia vera.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05143957.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Active
Contact: Bruck Habtemariam
Phone: 310-794-0242
This is a Phase 2a, multi-center, randomized, open-label study of sapablursen in up to 40
participants with PD-PV. The study consists of 4 periods: 1) Screening Period: up to 7
weeks; 2) Treatment Period: 37 weeks 3) Treatment Extension Period: 36 weeks; 4)
Post-treatment Period: 13 weeks.
In the Treatment Period, study drug is given by subcutaneous (under the skin)
injection(s). There will be a total of 9 doses given over about 8 months.
In the Treatment Extension Period, there will be a total of 9 doses given over about 8
months.
Participants will be assigned to receive one of 2 Dosing Levels - a higher or a lower
level, with an equal chance of being assigned to either Dosing Level. All participants
will receive study drug; there is no placebo.
This study was extended to allow participants to receive sapablursen for an additional 36
weeks following the initial 37-week treatment period.
Lead OrganizationIonis Pharmaceuticals, Inc.
