Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
Summary
This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 10 kg of body weight suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.
Timeline
- Start
- 2024-03-07
- Primary completion
- 2025-06-27
- Completion
- 2025-11-25
Outcome
Met primary endpoint
release “Phase III trial for KLU156 (ganaplacide/lumefantrine, or GanLum), meets primary endpoint of non-inferiority to standard of care Coartem® (artemether-lumefantrine)” novartis.com ↗
release “In the Phase III KALUMA trial for malaria, KLU156 met its primary endpoint of non-inferiority to the standard of care (SoC), Coartem.” novartis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Coartem | Unknown | — | Oral |
| Subject | Ganaplacide | Small molecule | 400 mg | Oral |
| Subject | lumefantrine | Small molecule | 480 mg | Oral |