A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

Summary

A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.

Timeline

Start

2020-10-08

Primary completion

2022-11-16

Completion

2027-09-30

Outcome

Met primary endpoint

paper Crovalimab was non-inferior to eculizumab in the co-primary endpoints of hemolysis control PMID 38884175 ↗

release “The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety” roche.com ↗

release “Approval based on COMMODORE 2 study, which demonstrated efficacy of monthly (every four weeks) subcutaneous (SC) PiaSky was non-inferior to intravenous eculizumab every two weeks” chugai-pharm.co.jp ↗

Publications

• Tong H, Lin Z, Yang C, Wang X, Sun J, Xia L, Shi J, Shi D, Zhang Z, Appius A, He G. Efficacy and safety of crovalimab versus eculizumab in complement inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria: Chinese subgroup analysis of the phase 3 COMMODORE 2 study. Ann Hematol. 2026 Jun 13. doi: 10.1007/s00277-026-07129-3. Online ahead of print.
• Kulasekararaj AG, Nishimura JI, Roth A, Beveridge L, Buatois S, Buri M, Compagno N, Luder Y, Sreckovic S, Scheinberg P. Managing transient immune complex reactions in patients with paroxysmal nocturnal hemoglobinuria: clinical observations from the COMMODORE 1 and 2 studies. Ther Adv Hematol. 2025 Sep 17;16:20406207251359246. doi: 10.1177/20406207251359246. eCollection 2025.
• Roth A, Fu R, He G, Alzahrani H, Chou SC, Hicheri Y, Kazmierczak M, Recova VL, Uchiyama M, Vladareanu AM, Beveridge L, Buatois S, Buri M, Compagno N, Shi D, Balachandran N, Sreckovic S, Scheinberg P. Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Haemoglobinuria (PNH): Pooled Results From the Phase 3 COMMODORE Studies. Eur J Haematol. 2025 Feb;114(2):373-382. doi: 10.1111/ejh.14339. Epub 2024 Nov 13.
• Roth A, He G, Tong H, Lin Z, Wang X, Chai-Adisaksopha C, Lee JH, Brodsky A, Hantaweepant C, Dumagay TE, Demichelis-Gomez R, Rojnuckarin P, Sun J, Hoglund M, Jang JH, Gaya A, Silva F, Obara N, Kelly RJ, Beveridge L, Buatois S, Chebon S, Gentile B, Lundberg P, Sreckovic S, Nishimura JI, Risitano A, Han B. Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition. Am J Hematol. 2024 Sep;99(9):1768-1777. doi: 10.1002/ajh.27412. Epub 2024 Jun 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Crovalimab	Monoclonal antibody	85 mg	Intravenous
Subject	Crovalimab	Monoclonal antibody	170 mg	Intravenous
Subject	Crovalimab	Monoclonal antibody	340 mg	Intravenous
Subject	Crovalimab	Monoclonal antibody	510 mg	Intravenous
Subject	Crovalimab	Monoclonal antibody	680 mg	Intravenous
Subject	Crovalimab	Monoclonal antibody	1020 mg	Intravenous
Comparator	Eculizumab	Monoclonal antibody	900 mg	—

Indications