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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).

NCT06997159 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-05

No results posted yet for this study

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).

Conditions

  • Localized Cutaneous Leishmaniasis

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-04-05
Completion
2028-04-05

Countries

  • Brazil
  • Panama

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997159 on ClinicalTrials.gov