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RECRUITINGPHASE2

A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.

A Randomized, Participant- and Investigator-blinded, Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LXE408 in Participants With Chronic Chagas Disease Without Severe Organ Dysfunction.

NCT06632600•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.

Detailed Description

This is an interventional, phase 2, PoC (Proof of Concept) randomized, participant- and investigator-blinded, controlled, parallel group study, with 4 treatment arms. The purpose of this study is to assess the efficacy (anti-parasitological activity), safety, PK (pharmacokinetics), and PD (pharmacodynamics) of LXE408 in participants with CICD (chronic indeterminate Chagas disease) and chronic Chagas disease without severe cardiac or gastrointestinal dysfunction compared to placebo and to benznidazole.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female participants aged ≥ 18 years to ≤ 60 years old
•Confirmed diagnosis of T. cruzi infection
•History that participant has been determined to be in chronic phase of CD
•Written informed consent must be obtained before any assessment is performed, and participants should express understanding of the consent form and the study
•Participants must be considered by the investigator eligible for and able to comply with local prescribing information for benznidazole
•Ability and willingness to communicate well with the investigator/study site and comply with requirements of the study

Exclusion Criteria

•Signs (on physical examination) and/or symptoms of CD in the acute phase as determined by the investigator at screening
•History of CD treatment with benznidazole or nifurtimox at any time in the past
•History of and/or current (at screening) symptoms or signs (physical examination findings) of moderate or severe CD-related gastrointestinal disease
•Participants who weigh \< 50 kg or \>90kg at screening
•At sites conducting the MRI assessments, participants may participate in the overall study, but will be excluded from the MRI assessment if they have contraindications to MRI imaging
•Any clinically significant disease during screening that, in the opinion of the investigator, would put the safety of the participant at risk through participating, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study, or would compromise participant compliance or preclude completion of the study
•Documented history or current findings at screening of clinically significant cardiovascular conditions such as, but not limited to: unstable ischemic heart disease; NYHA Class III/IV heart failure (due to Chagas disease or other conditions); arrhythmias
•Known or suspected ongoing, chronic or recurrent viral, bacterial or fungal infectious diseases including but not limited to: Tuberculosis, leishmaniasis, severe malaria, atypical mycobacterial infection, listeriosis, aspergillosis, or endemic mycoses, and/or documented positivity for human immunodeficiency virus (HIV) infection.
•* Participants with controlled HIV on antiretroviral therapy are eligible to participate if CD4 ≥ 500 at screening
•History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years prior to screening (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
+14 more criteria

Locations (18)

Olive View UCLA Educ and Res Ins

Sylmar, California, United States

University of Florida Shands

Gainesville, Florida, United States

Boston Medical Center

Boston, Massachusetts, United States

Baylor College of Medicine

Houston, Texas, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Formosa, Argentina

Novartis Investigative Site

Montes Claros, Minas Gerais, Brazil

Key Dates

Start Date

April 28, 2025

Primary Completion Date

March 22, 2027

Completion Date

September 21, 2030

Last Updated

February 5, 2026

Enrollment

130

ESTIMATED participants

Conditions

Chagas Disease

Interventions

LXE408

DRUG

Placebo

DRUG

Benznidazole

DRUG

Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

New Therapies and Biomarkers for Chagas Infection

NCT03981523

Trypanosoma Cruzi InfectionChagas Disease

View study

COMPLETEDPHASE3

BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease

NCT00123916

Chagas DiseaseTrypanosomiasis+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.

Inclusion Criteria

Exclusion Criteria

New Therapies and Biomarkers for Chagas Infection

BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease

Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram

Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease

Improving Blood Safety and HIV Testing in Brazil

Galectin-3 as a Biomarker in Patients With Chagas Disease