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An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Trial Profile

An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Dec 2023

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At a glance

  • Drugs Crovalimab (Primary) ; Crovalimab (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Acronyms COMPOSER
  • Sponsors Chugai Pharmaceutical; Roche

    • Most Recent Events

    • 01 Aug 2023 Results assessing long-term outcomes crovalimab in patients with paroxysmal nocturnal haemoglobinuria, published in the European Journal of Haematology.
    • 20 Jan 2023 Results published in the Clinical Pharmacology and Therapeutics
    • 13 Dec 2022 Results (from two studies COMPOSER and COMMODORE 3) characterizing the relationship between crovalimabs exposure parameters and pharmacodynamic biomarkers, efficacy, and safety of Crovalimab in Patients with Paroxysmal Nocturnal Hemoglobinuria presented at the 64th American Society of Hematology Annual Meeting and Exposition
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