NCT06997159

A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).

A Randomized, Multicentre, Observer-blind Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Regimens and Miltefosine as an Active Control in Patients With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to measure efficacy, safety and pharmacokinetics (PK) of two LXE408 oral regimens and oral miltefosine tablets as active control in localized cutaneous leishmaniasis in the region of the Americas (AMR), and assess its suitability for use in monotherapy for the treatment of patients with cutaneous leishmaniasis (CL).

Detailed description

Participants who met all inclusion criteria and none of the exclusion criteria will be randomized to the study will be allocated to one of three arms in a 2:2:1 ratio. * Arm 1: LXE408 BID for 14 days followed by placebo BID for 14 days * Arm 2: LXE408 BID for 28 days * Arm 3: Miltefosine 50 mg PO TID for 28 days orally Each arm will consist of a screening period of up to 15 days, a 28-day treatment period, and a follow-up period from Day 29 to Day 180. During the treatment period, all participants will return to the sites at Days 1, 8, 15, 22 and 29 (+/- 2 days). During the follow-up period they will return for the Day 63 (+/- 7 days), Day 90 (+/- 7 days) and Day 180 (+/- 14 days) visits. If at D90 participants present a re-epithelization of the ulcer(s) more or equal to 75% but less than 100%, they will be asked to return at D105 for a late responder assessment.

Conditions

• Localized Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	LXE408	LXE408 film-coated tablets.
DRUG	Miltefosine 50 MG Oral Capsule [Impavido]	Each capsule contains 50 mg miltefosine in an opaque, red, hard gelatin capsule. Capsules are supplied in packs of 56 capsules sealed in 8 aluminum blister stripes, each containing 7 capsules.
DRUG	Placebo to LXE408	Film-coated tablets.

Timeline

• Start date: 2025-11-16
• Primary completion: 2027-07-10
• Completion: 2027-07-10
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

5 sites across 2 countries: Brazil, Panama