This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
Male and female participants 2 to <12 years of age at screening.
Participants must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 1,000 to 150,000 asexual parasite count/μl of blood for P. falciparum.
Participants must weigh at least 10 kg at screening.
Participants with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
AST/ALT > 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
AST/ALT > 1.5 and ≤ 2 x ULN and total bilirubin is > ULN
Parallel
KAE609
Drugoral capsules administered in combination with KLU156
SoC (Coartem)
DrugStandard of Care
KLU156
Drugoral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609)
Polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)
ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).
Parasite clearance time (PCT)
To assess the parasite clearance time (PCT) of oral anti malarial agent versus the standard of care (SoC) in participants with uncomplicated P. falciparum malaria
PCR-uncorrected ACPR
To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the SoC in participants with uncomplicated P. falciparum malaria.
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Maximum observed concentration (Cmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
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