A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis

Phase 2 Completed 101 enrolled Drugs for Neglected Diseases Novartis Pharmaceuticals · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a phase II, multicentre, randomized, two-arm blinded study with an open label calibrator arm in adults and adolescents (≥12 years) with confirmed primary VL.

Timeline

Start: 2022-12-27
Primary completion: 2025-04-15
Completion: 2025-12-22

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amphotericin B	Unknown	10 mg/kg	Intravenous
Subject	LXE408	Small molecule	—	—

A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis

Summary

Timeline

Drugs

Indications