Phase 2
N=60
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)
Uncomplicated Plasmodium Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT07235033 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Polymerase Chain Reaction (PCR) Corrected Adequate Clinical and Parasitological Response (ACPR) — 96.43; 96.67 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KAE609 (Drug); SoC (Coartem) (Drug); KLU156 (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Polymerase Chain Reaction (PCR) Corrected Adequate Clinical and Parasitological Response (ACPR) |
96.43; 96.67 | — |
| SECONDARY Parasite Clearance Time (PCT) |
12.1; 47.7 | — |
| SECONDARY PCR Uncorrected Adequate Clinical and Parasitological Response (ACPR) |
86.67; 93.33 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
1150; 804; 8280 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
8.03; 4.08; 8.11 | — |
| SECONDARY Area Under Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h) |
18600; 10800; 126000 | — |
| SECONDARY Area Under Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48h) |
31300; 16100; 199000 | — |
| SECONDARY Area Under Plasma Concentration-time Curve (AUClast) |
45200; 21800; 270000 | — |
| SECONDARY Area Under Plasma Concentration-time Curve (AUC[0-inf]) |
49700; 23200; 326000 | — |
| SECONDARY Terminal Elimination Half-life (T1/2) |
22.7; 28.1; 40.9 | — |
| SECONDARY Apparent Clearance (CL/F) |
1510; 17200; 1470 | — |
| SECONDARY Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) |
47200; 688000; 88000 | — |
Summary
This was Cohort B2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
Eligibility Criteria
Inclusion Criteria
- Male and female patients ≥12 years of age at screening.
- Patients 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.
- Patients must weigh between 35 kg and 90 kg at screening.
- Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
Exclusion Criteria
- Patients 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 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
- Total bilirubin > 2 x ULN, regardless of the level of AST/ALT
- Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
- Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
- Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
- History of familial long QT syndrome or known family history of Torsades de Pointe.
- Resting heart rate (physical exam or 12 lead ECG) < 50 bpm
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT07235033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.