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An Adaptive, Randomized, Active-controlled, Open-label, Sequential Cohort, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Intravenous Cipargamin (KAE609) in Adult and Pediatric Participants With Severe Plasmodium Falciparum Malaria (KARISMA - KAE609's Role In Severe Malaria)

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Trial Profile

An Adaptive, Randomized, Active-controlled, Open-label, Sequential Cohort, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Intravenous Cipargamin (KAE609) in Adult and Pediatric Participants With Severe Plasmodium Falciparum Malaria (KARISMA - KAE609's Role In Severe Malaria)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Jan 2026

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At a glance

  • Drugs Cipargamin (Primary) ; Artemether/lumefantrine; Artesunate
  • Indications Falciparum malaria; Malaria
  • Focus Therapeutic Use
  • Acronyms KARISMA
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 12 Sep 2025 Status changed from active, no longer recruiting to completed.
  • 21 Aug 2025 Planned End Date changed from 26 Sep 2025 to 29 Aug 2025.
  • 21 Aug 2025 Status changed from recruiting to active, no longer recruiting.

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