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). | Biotech Hunter

Enrollment

250

Participants

Timeline

Start Date

November 16, 2025

Primary Completion Date

July 10, 2027

Study Completion Date

July 10, 2027

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.

Trial Locations (5)

Unknown

Foundation of Tropical Medicine Dr. Heitor Vieira Dourado, Manaus

Federal University of Maranhão, São Luís

Julio Muller University Hospital/ Federal University of Mato Grosso, Cuiabá

René Rachou Institute /Oswaldo Cruz Foundation- FIOCRUZ MINAS, Belo Horizonte

Instituto Conmemorativo Gorgas de Estudios de la Salud, Panama City