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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: 01 Sep 2026

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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

  • 26 Aug 2026 Planned End Date changed from 31 Dec 2026 to 15 Jan 2027.
  • 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.

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