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A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

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Trial Profile

A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Mar 2025

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At a glance

  • Drugs Crovalimab (Primary) ; Crovalimab (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Registrational; Therapeutic Use
  • Acronyms COMMODORE 3
  • Sponsors Roche

Most Recent Events

  • 13 Mar 2025 Planned End Date changed from 18 Feb 2028 to 31 Dec 2026.
  • 27 Aug 2024 According to a Roche media release, based on the results from the Phase III COMMODORE 2 study in people with PNH who have not been previously treated with C5 inhibitors and supportive data from two additional Phase III studies, the COMMODORE 1 study and the COMMODORE 3 study the company has received an approved to PiaSky (crovalimab) from the European Commission.
  • 08 Feb 2024 According to a Chugai Pharmaceutical media release, company announced crovalimab was approved by the National Medical Products Administration (NMPA) of Peoples Republic of China for treatment of adults and adolescents (12 years of age and above) with PNH not been previously treated with complement inhibitors. The regulatory application was filed by a China affiliate of Roche. Approval based on several studies including a COMMODORE 3 and COMMODORE 2.

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