Last updated 3 months ago
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).
250 patients around the world
Available in Brazil, Panama
Participants who met all inclusion criteria and none of the exclusion criteria will be randomized to the study will be allocated to one of three arms in a 2:2:1 ratio.
- Arm 1: LXE408 BID for 14 days followed by placebo BID for 14 days
- Arm 2: LXE408 BID for 28 days
- Arm 3: Miltefosine 50 mg PO TID for 28 days orally
Each arm will consist of a screening period of up to 15 days, a 28-day treatment period, and a follow-up period from Day 29 to Day 180. During the treatment period, all participants will return to the sites at Days 1, 8, 15, 22 and 29 (+/- 2 days). During the follow-up period they will return for the Day 63 (+/- 7 days), Day 90 (+/- 7 days) and Day 180 (+/- 14 days) visits. If at D90 participants present a re-epithelization of the ulcer(s) more or equal to 75% but less than 100%, they will be asked to return at D105 for a late responder assessment.
Drugs for Neglected Diseases
3Research sites
250Patients around the world
This study is for people with
Leishmaniasis
Cutaneous Leishmaniasis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participant must be aged ≥18 years old and weighing > 50kg.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.A diagnosis of CL confirmed by at least one of the following methods.Microscopic identification of amastigotes in stained lesion tissue.Demonstration of Leishmania by PCR.Positive culture for promastigotes.In the opinion of the investigator, the participant is capable of understanding and complying with the protocol, including visits up to 6 months after study start.Written informed consent must be obtained before any study protocol specific assessment is performed other than procedures performed as part of standard of care.Participants must be able to give written informed consent.
- Female with a positive blood pregnancy test at screening or who is breastfeeding, lactating or women of childbearing potential 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 including any immunocompromising condition.History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years.Participants newly diagnosed with HIV infection on the basis of the trial screening testing or other recent testing are excluded.Participants with active infectious conditions, such as tuberculosis, or history or active hepatitis B virus or hepatitis C virus infection are excluded.ECG abnormalities, either historic or current which, in the view of the investigator, indicate a significant risk to study participation.Clinically significant cardiac arrhythmias.QTcF ≥450 ms.History of familial long QT syndrome or known family history of Torsades de Pointes.Resting heart rate <60 bpm.Participants who are receiving or have received antileishmanial medication, or prohibited medication or any medication that might interfere with the therapeutic response or cause harmful interactions with study medications.Has laboratory values at screening as follows: Serum creatinine: ≥1.5 times ULN, ALT, AST, GGT, ALP: >1.5 times above upper normal level.Known history of addiction or alcohol abuse.Hypersensitivity to miltefosine or any study medication excipients.Participants with Sjogren-Larsson Syndrome.
Sites
Fundación Oswaldo Cruz - FIOCRUZ
Fundação De Medicina Tropical Doutor Heitor Vieira Dourado
Universidad Federal de Mato Grosso do Sul
SponsorDrugs for Neglected Diseases
Study typeInterventional
Conditions
Cutaneous Leishmaniasis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06997159
