drugset / Trial / 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).
Phase 2
Not yet recruiting
250 enrolled
Drugs for Neglected Diseases
Novartis Pharmaceuticals · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2026-06-15
- Primary completion
- 2028-04-05
- Completion
- 2028-04-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LXE408 | Small molecule | — | Oral |
| Comparator | Miltefosine | Small molecule | 50 mg | Oral |