A Phase 2 interventional study of KAE609 (Cipargamin) and SoC (Coartem) in Uncomplicated Plasmodium Falciparum Malaria, sponsored by Novartis Pharmaceuticals. Completed at 13 sites in 7 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
This is Cohort B1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 + Cipargamin in participants with uncomplicated Plasmodium falciparum malaria.
The Cohort B1 of this Platfom study (NCT05750628) is the open-label, randomized, two-arm combination therapy evaluating a dose of up to two anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in adult and adolescent participants.
Exclusion Criteria:
Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:
History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
Other protocol-defined inclusion/exclusion criteria may apply.
Cohort B1: Cipargamin + INE963
Drug: KAE609 (Cipargamin) · Drug: INE963
Cohort B1: SoC (Artemether 80 mg + lumefantrine 480 mg)
Drug: SoC (Coartem)
oral KAE609 (Cipargamin)
Also known as: KAE609
SoC (Coartem)
oral INE963
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).
Time frame: Day 29
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
Time frame: up to Day 7
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.
Time frame: Day 29
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.
Time frame: Day 8
Maximum observed concentration (Cmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Time to reach maximum observed concentration (Tmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Elimination half-life (T1/2)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Total body clearance (CL/F)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Apparent volume of distribution (V/F)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Area under the concentration-time curve from time zero to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Area under the concentration-time curve (AUC0-t)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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