Clinical Trial

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).

Not Yet Recruiting Phase 2
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-21.
Trial Details
NCT Number NCT06997159
Lead Sponsor Drugs for Neglected Diseases
Collaborators: Novartis Pharmaceuticals
Conditions Localized Cutaneous Leishmaniasis
Enrollment 250 participants
Start Date 2026-06-15
Primary Completion 2028-04-05 (estimated)
Study Completion 2028-04-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-05