Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05842954 | Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria | PHASE3 | COMPLETED | 1,720 | — | — | Mar 7, 2024 | Nov 25, 2025 | Jan 27, 2026 | 33 | Burkina Faso, Côte d’Ivoire +10 |
To confirm the efficacy of KLU156 in adults and children ≥ 10 kg of body weight suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection) by demonstrating that KLU156 is non-inferior to Coartem (non-inferiority margin = 5%) based on the PCR-corrected ACPR at Day 29. This primary outcome is applicable to non-US submission.
To further confirm the efficacy of KLU156 by demonstrating non-inferiority of KLU156 to Coartem (NI margin 7.5%) based on the uncorrected ACPR at Day 29. This primary outcome is applicable to US New Drug Application (NDA) submission.
| Arm | Type | Description |
|---|---|---|
| KLU156 | EXPERIMENTAL | KLU156 once daily (QD) for 3 days under fed conditions (light meal). |
| Coartem | ACTIVE_COMPARATOR | Coartem twice a day (BID) for 3 days under fed conditions. |
| Name | Type | Description |
|---|---|---|
| KLU156 | DRUG | Oral use. KLU156 (400/480 mg) is the dose for patients with a bodyweight ≥ 35kg. Patients \< 35kg will take a fraction of the dose according to weight group as defined in the protocol. |
| Coartem | DRUG | Oral use. Dosing will be selected based on patient's body weight as per product's label. |
Key Inclusion criteria (Core phase) 1. Male or female patients ≥ 10 kg of body weight. 2. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia ≥ 1,000 and ≤ 200,000 parasites/µL at the time of pre-screening with or without other Plasmo...