drugset / Trial / NCT05957978
LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open-label, phase II, single-centre study, with one LXE408 regimen and one calibrator arm with the standard of care SSG combined with PM, to be conducted in male and female adult (≥18 years and \<45 years) patients with confirmed primary visceral leishmaniasis in Ethiopia.
Timeline
- Start
- 2024-03-29
- Primary completion
- 2025-06-27
- Completion
- 2025-11-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LXE408 | Small molecule | — | Oral |
| Comparator | Paromomycin | Small molecule | 15 mg/kg | Intramuscular |
| Comparator | sodium stibogluconate | Unknown | 20 mg/kg | Intravenous |