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).
Participant must be aged ≥18 years old and weighing > 50kg
≤ 6 lesions
At least one lesion of > 50 mm2 of area
a history of CL of no longer than 6 months
Female with a positive blood pregnancy test at screening or who is breastfeeding, lactating or women of childbearing potential (defined as women physiologically capable of becoming pregnant) who does not agree to use two methods of contraception, one barrier method and one highly effective method. In Brazil: for 30 days prior to the treatment onset and up to D180 visit. In Panama: during treatment period up to D180 visit.
Sexually active male, including those post-vasectomy, unwilling to use a condom during intercourse with female partner while taking the investigational drug and for 5 days, after stopping the investigational drug.
Has diagnosis or suspected diagnosis of mucocutaneous, disseminated or diffuse leishmaniasis based on physical exam.
Current clinically significant medical problems (e.g., cardiac, renal, hepatic, pancreatic diseases, current cutaneous conditions that may interfere with CL evolution or healing, past and current ocular disorders, especially keratitis, uveitis, scleritis), including any immunocompromising condition (such as having a known diagnosis for HIV, transplanted patients, those in treatment for auto immune diseases, patients receiving immunosuppressant, immunobiological or antineoplastic treatments).
Parallel
LXE408
DrugLXE408 film-coated tablets.
Miltefosine 50 MG Oral Capsule [Impavido]
DrugEach 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
DrugFilm-coated tablets.
Proportion of participants who achieved Cure at Day 180
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
Proportion of participants with treatment-emergent adverse events (TEAEs) and SAEs
Proportion of participants with • Abnormalities from physical exam, vital signs, ECGs and safety laboratory assessments
Proportion of participants who achieved Cure at Day 90
Cure at Day 90 (D90) is defined as: * 100% re-epithelization of ulcerated lesions (if any) or flattening and/or no signs of induration of non-ulcerated lesions (if any) at D90; * no rescue therapy up to D90. * No-death regardless of cause up to D90.
Pharmacokinetics (PK) of LXE408 - Cmax
Maximum plasma concentration
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Drugs for Neglected Diseases
Lead sponsor
Novartis Pharmaceuticals
Collaborator
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