A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH

Phase 3 Completed 42 enrolled Amgen

RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.

Timeline

Start: 2019-01-22
Primary completion: 2022-07-12
Completion: 2022-07-12

Outcome

Met primary endpoint

paper Similarity of efficacy was established by a ratio of geometric least squares means of LDH (ABP 959/eculizumab RP) of 1.0628 PMID 39171864 ↗

release “The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and SOLIRIS based on the control of intravascular hemolysis” amgen.com ↗

Publications

Kulasekararaj A, Lanza F, Arvanitakis A, Langemeijer S, Chonat S, Tombak A, Hanes V, Cao J, Miller MJ, Colbert A, Shander B, Mytych DT, Chow V, Henary H. Comparative clinical efficacy and safety of biosimilar ABP 959 and eculizumab reference product in patients with paroxysmal nocturnal hemoglobinuria. Am J Hematol. 2024 Nov;99(11):2108-2117. doi: 10.1002/ajh.27456. Epub 2024 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABP 959	Unknown	—	Intravenous
Subject	Eculizumab	Monoclonal antibody	—	Intravenous