NCT05957978

LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study

A Randomized, Open-label, Phase II, Single-centre Study to Evaluate the Efficacy, Safety and Pharmacokinetics of LXE408 in Patients With Primary Visceral Leishmaniasis in Ethiopia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will enrol and randomize approximately 52 patients aged ≥18 years and \<45 years in a ratio of 3:1 (arm 1 to arm 2): * Arm 1: LXE408 orally once daily for 14 days (39 patients) * Arm 2: Standard of care sodium stibogluconate 20 mg/kg/day intravenous/intramuscular (IV/IM) q.d. and paromomycin 15 mg/kg/day IM q.d. for 17 days (13 patients) In both arms, the study will consist of a screening period of up to 7 days, a treatment duration of 14 or 17 days, and a follow-up period from end of treatment to Day 180. All patients will be hospitalized for approximately 21-24 days, from the first day of the screening period to the Day 14 or Day 17 visit (LXE408 or SSG/PM arms, respectively), after which they are expected to be discharged. They will return to the study sites at the scheduled Day 28 visit (±1 day) for the initial test of cure (primary endpoint), at Day 56 visit (± 7 days) and for the EOS visit at Day 180 (± 14 days) for the final assessment of cure (secondary endpoint). In addition, during follow-up between Day 56 and Day 180, the study team will contact the study patients by phone on a monthly basis to check on their well-being and any reappearance of VL symptoms. This study is run by DNDi with Novartis as co-development partner.

Conditions

• Primary Visceral Leishmaniasis

Interventions

Type	Name	Description
DRUG	LXE408	Film-coated tablets
DRUG	sodium stibogluconate	Dosage/Administration: sodium stibogluconate 20 mg/kg/day intravenous/intramuscular (IV/IM) q.d.
DRUG	Paromomycin	Dosage/Administration: paromomycin 15 mg/kg/day IM q.d.

Timeline

• Start date: 2024-03-29
• Primary completion: 2025-06-27
• Completion: 2025-11-13
• First posted: 2023-07-24
• Last updated: 2025-12-18

Locations

1 site across 1 country: Ethiopia