Last Updated: 27/11/2025

Efficacy, safety and tolerability of KLU156 in adults and children ≥ 5 kg body weight with uncomplicated P. Falciparum malaria (KALUMA)

Objectives

This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection). In the extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the extension phase.

Principal Institution

Novartis Pharmaceuticals, Novartis, Switzerland

Partner Institutions

Medicines for Malaria Venture (MMV), Switzerland

Rationale and Abstract

The purpose of this study is to confirm the efficacy, safety and tolerability of KLU156 in patients with uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection) by demonstrating that KLU156 is non-inferior to Coartem.

The study duration will be 43 days (Core phase) plus 24 months (Extension phase).
The treatment duration will be 3 days for each malaria episode.
The visit frequency will be Days 1-3 (hospitalized) and 5 follow-up visits (Days 4, 8, 22, 29 and 43) in the Core phase and Days 1-3 (hospitalized) and 3 follow-up visits (Days 4, 8 and 29) in the Extension phase.

The KALUMA study follows the promising results announced in November 2024 of the phase 2b trial of the novel, non-artemisinin drug ganaplacide (also known as KAF156) combined with a new once-daily formulation of lumefantrine in young children (6 months to 2 years old). Given the promising findings, the investigators started an efficacy phase 3 trial in March 2024 using the same formulation as in the phase 2b study in patients weighing ≥ 5 kg and aged ≥ 2 months, suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection).

The treatment was developed within the framework of the WANECAM2 consortium.

Study Design