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Phase 2 N=60 Randomized Treatment

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

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

OutcomeResultp-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.

View full record on ClinicalTrials.gov →

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.

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