Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

Phase 2 Completed 70 enrolled Protagonist Therapeutics, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera.

Timeline

Start: 2019-10-01
Primary completion: 2023-02-14
Completion: 2024-06-17

Outcome

Met primary endpoint

paper During part 2, a response was observed in 60% of the patients who received rusfertide as compared with 17% of those who received placebo (P = 0.002). PMID 38381675 ↗

release “The randomized portion of the Phase 2 REVIVE study of rusfertide in Polycythemia Vera achieved its primary endpoint.” takeda.com ↗

Publications

Kremyanskaya M, Kuykendall AT, Pemmaraju N, Ritchie EK, Gotlib J, Gerds A, Palmer J, Pettit K, Nath UK, Yacoub A, Molina A, Saks SR, Modi NB, Valone FH, Khanna S, Gupta S, Verstovsek S, Ginzburg YZ, Hoffman R; REVIVE Trial Investigators. Rusfertide, a Hepcidin Mimetic, for Control of Erythrocytosis in Polycythemia Vera. N Engl J Med. 2024 Feb 22;390(8):723-735. doi: 10.1056/NEJMoa2308809.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rusfertide	Peptide	—	—