| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05750628 | Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria | PHASE2 | RECRUITING | 327 | — | — | Jan 23, 2024 | Jun 23, 2026 | Jul 30, 2025 | 12 | Burkina Faso, Côte d’Ivoire +4 |
| NCT07235020 | Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria | PHASE2 | COMPLETED | 52 | — | — | Jan 23, 2024 | Feb 21, 2025 | Nov 19, 2025 | 6 | Burkina Faso, Côte d’Ivoire +4 |
Part A: To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
Part B and C: To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria. 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).
To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
| Arm | Type | Description |
|---|---|---|
| Cohort A1: Dose Level 1 INE963 | EXPERIMENTAL | Cohort A1: Dose Level 1 INE963 |
| Cohort A1: Dose Level 2 INE963 | EXPERIMENTAL | Cohort A1: Dose Level 2 INE963 |
| Cohort A1: Dose Level 3 INE963 | EXPERIMENTAL | Cohort A1: Dose Level 3 INE963 |
| Cohort B1: Cipargamin + INE963 | EXPERIMENTAL | Cohort B1: Cipargamin + INE963 |
| Cohort B1: SoC (Coartem) | ACTIVE_COMPARATOR | Cohort B1: SoC (Coartem) |
| Cohort B2: Cipargamin + KLU156 | EXPERIMENTAL | Cohort B2: Cipargamin + KLU156 |
| Cohort B2: SoC (Coartem) | ACTIVE_COMPARATOR | Cohort B2: SoC (Coartem) |
| Cohort C2: Cipargamin + KLU156 | EXPERIMENTAL | Cohort C2: Cipargamin + KLU156 |
| Cohort C2: SoC (Coartem) | ACTIVE_COMPARATOR | Cohort C2: SoC (Coartem) |
| Cohort A1: Dose Level 4 INE963 | EXPERIMENTAL | Cohort A1: Dose level 4 INE963 |
| Cohort A1: INE963 Dose Level 1 | EXPERIMENTAL | Cohort A1: INE963 Dose Level 1 |
| Cohort A1: INE963 Dose Level 2 | EXPERIMENTAL | Cohort A1: INE963 Dose Level 2 |
| Cohort A1: INE963 Dose Level 3 | EXPERIMENTAL | Cohort A1: INE963 Dose Level 3 |
| Cohort A1: INE963 Dose Level 4 | EXPERIMENTAL | Cohort A1: INE963 Dose Level 4 |
| Name | Type | Description |
|---|---|---|
| INE963 | DRUG | oral INE963 |
| KAE609 (Cipargamin) | DRUG | oral KAE609 (Cipargamin) |
| SoC (Coartem) | DRUG | SoC (Coartem) |
| KLU156 | DRUG | oral sachet KLU156 (KAF156 + lumefantrine) |
Inclusion Criteria: 1. Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part B and 2 to \<12 years of age for Part C at screening. 2. Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150...