Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | PHASE2 | NOT YET_RECRUITING | 250 | — | — | Jun 15, 2026 | Apr 5, 2028 | May 5, 2026 | 5 | Brazil, Panama |
Cure at Day 180 (D180) is defined as: * 100% re-epithelialization of ulcerated lesions (if any) or flattening and/or no signs of induration of non-ulcerated lesions (if any) up to and at D90 and, * no relapse by D180, and * no rescue therapy up to D180 * no death, regardless of cause, up to D180
| Arm | Type | Description |
|---|---|---|
| LXE408 BID for 14 days | EXPERIMENTAL | LXE408 BID for 14 days followed by placebo BID for 14 days. |
| LXE408 BID for 28 days | EXPERIMENTAL | - |
| Miltefosine 50 mg PO TID for 28 days | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| LXE408 | DRUG | LXE408 film-coated tablets. |
| Miltefosine 50 MG Oral Capsule [Impavido] | DRUG | 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. |
| Placebo to LXE408 | DRUG | Film-coated tablets. |
Inclusion Criteria: 1. Participant must be aged ≥18 years old and weighing \> 50kg 2. Participant with first episode of CL fulfilling the following characteristics: * ≤ 6 lesions * At least one lesion of \> 50 mm2 of area * a history of CL of no longer than 6 months 3. a diagnosis of CL c...