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NOT YET RECRUITING
NCT07859423
PHASE2/PHASE3

A Study to Investigate AG-236 in Subjects ≥18 Years of Age With Polycythemia Vera

Sponsor: Agios Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

AG-236

SC Injection

DRUG

Placebo

SC Injection