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A Study to Investigate AG-236 in Subjects ≥18 Years of Age With Polycythemia Vera
Sponsor: Agios Pharmaceuticals, Inc.
Summary
This clinical trial is a Phase 2/3 study that will determine the recommended dose and dose regimen of AG-236 and evaluate the efficacy, safety, and pharmacokinetics of AG-236 in polycythemia vera (PV) by testing how well AG-236 works compared to placebo to increase the number of subjects with no phlebotomy and absence of phlebotomy eligibility over a 13-week period. In addition, the long-term effect of AG-236 on efficacy and safety will be explored in an open-label extension portion.
Official title: A Phase 2/3, Double-blind, Randomized, Placebo-Controlled, Multicenter, Efficacy, Safety, and Pharmacokinetics Study of AG-236 in Subjects With Polycythemia Vera
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
245
Start Date
2026-11
Completion Date
2032-08
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
AG-236
SC Injection
Placebo
SC Injection