KALUMA: A randomized, open-label, multicenter study to compare efficacy, safety, and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an extension phase with repeated KLU156 treatment

Objectives

The primary objective of this projects is to confirm the efficacy of KLU156 in adults and children >= 5.0 kg body weight and >=2.0 months of age suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium species co-infections) by demonstrating that KLU156 is non-inferior to Coartem, non-inferiority margin of 5%, based on PCR corrected adequate clinical and parasitological response (ACPR) on day 29.

Secondary objectives are:

1. To further confirm the efficacy of KLU156 by demonstrating that KLU156 is non-inferior to Coartem, (non-inferiority margin of 7.5%), based on uncorrected ACPR on day 29.
2. To confirm the efficacy of KLU156 by assessing uncorrected and PCR-corrected ACPR at additional time points, as well as fever and parasite clearance time, gametocyte carriage over time between two treatment arms.
3. To compare the safety and tolerability of the two treatment arms of adverse events, general laboratory, vital signs, and ECG measurements.