Chagas DiseasePhase 2NCT06632600
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
A Phase 2 study testing LXE408 and Benznidazole in people with Chagas Disease, run by Novartis Pharmaceuticals at 22 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- LXE408 and Benznidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 28 Apr 2025to 21 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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)
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant during the study period
- Pancreatic injury or pancreatitis: If any single parameter of amylase or lipase exceeds 1.5x ULN at screening Participants with known recurrent pancreatitis (more than 1 episode in lifetime, from any cause) are excluded
- Liver disease or liver injury as indicated by abnormal liver function tests (LFTs):
- Any single parameter of ALT, AST, alkaline phosphatase must not exceed 1.5x ULN at screening Serum bilirubin must not exceed the ULN at screening elevated serum bilirubin is not excluded if there is a documented history of Gilbert's Syndrome
- History of renal disease as indicated by creatinine level above 1.5x ULN or microalbuminuria at screening; Evidence of urinary obstruction, or difficulty in voiding at screening; evidence of congenital renal abnormalities with known effect on renal function; calculated eGFR <60 mL/min (<0.835 mL/s) using the CKD-EPI formula for adults
- Participants with screening hematology parameters outside of the thresholds
- Current use of medications prohibited by the protocol at screening and/or baseline visits, or expected use of any prohibited medication during the study treatment period
- Use of benznidazole in the blinded arms is prohibited until unblinding occurs after all participants complete Month 12.
- Use of other investigational drugs at the time of study drug dosing
- History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study or to benznidazole
- History of drug abuse or unhealthy alcohol use within the 12 months prior to dosing
- Pregnant or nursing (lactating/breast-feeding) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping of investigational drug and benznidazole
- Participants who, in the opinion of the investigator, will not be able to comply with study procedures or visits, adhere to dosing schedule, or other otherwise be in compliance with study requirements
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
22 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
22 sites in 4 countries
Argentina6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Caba, C1015ABO
- Recruiting
Novartis Investigative Site
CABA, Buenos Aires, C1221ADC
- Recruiting
Novartis Investigative Site
CABA, Buenos Aires, C1407FWE
- Recruiting
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KEH
- Recruiting
Novartis Investigative Site
Corrientes, W3400CDS
- Recruiting
Novartis Investigative Site
Formosa, P3600KGC
Brazil6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Montes Claros, Minas Gerais, 39401-001
- Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90601-000
- Recruiting
Novartis Investigative Site
Recife, Pernambuco, 50100-060
- Recruiting
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21040-360
- Recruiting
Novartis Investigative Site
São Caetano do Sul, São Paulo, 09521-160
- Recruiting
Novartis Investigative Site
São Paulo, São Paulo, 01232-010
Colombia6 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Barranquilla, Atlántico, 080005
- Recruiting
Novartis Investigative Site
Bogotá, 110131
- Recruiting
Novartis Investigative Site
Bogotá, 111411
- Recruiting
Novartis Investigative Site
Floridablanca, 681017
- Recruiting
Novartis Investigative Site
San Gil, 684031
- Active, not recruiting
Novartis Investigative Site
Yopal, Casanare Department, 850009
United States4 sites, 4 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Samantha Roche, Samantha.roche@bmc.org
Dan Bourque
- Recruiting
University of Florida Shands
Gainesville, Florida, 32610-0486
Alexandra Taylor, tayloralexandra@ufl.edu
Norman Beatty
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030-3411
Gaby McLucas, mclucas@bcm.edu
Eva Clark
- Recruiting
Olive View UCLA Educ and Res Ins
Sylmar, California, 91342
Rosario Machicado, +1 818 364 4287, RMachicado@dhs.lacounty.gov
Jonathan Soverow
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Chagas Disease
- Being tested
- LXE408, Placebo, Benznidazole
- Keywords
- LXE408, Chronic Chagas disease, Chronic indeterminate Chagas disease, Chronic Chagas disease without severe organ dysfunction, CICD, Chronic CD, Trypanosoma cruzi
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LXE408Drug
LXE408 administered by oral route
PlaceboDrug
Placebo administered by oral route
BenznidazoleDrug
Benznidazole administered by oral route (administered as standard of care)
| Study group | Role | What they receive |
|---|---|---|
| LXE408 28 days | Experimental | LXE408 administered by oral route |
| LXE408 14 days and Placebo 14 days | Experimental | LXE408 administered by oral route, followed by Placebo administered by oral route Receives: Drug: LXE408; Drug: Placebo |
| Placebo 28 days | Placebo comparator | Placebo administered by oral route Receives: Drug: Placebo |
| Benznidazole 60 days | Active comparator | Benznidazole administered by oral route Receives: Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 28 days versus placebo.
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
Measured: At Months 2, 4, and 6
Secondary outcomes (13)
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 -14 days versus placebo
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
Measured: At Months 2, 4, and 6
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months-LXE408 - 28 days and 14 days versus benznidazone
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
Measured: At Months 2, 4, and 6
Presence or absence of early parasitological clearance
The parasitological load will be measured using polymerase chain reaction (PCR). The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample.
Measured: At Day 7, 14 and 28
Presence or absence of sustained parasitological clearance over 12 months by PCR testing
The parasitological load will be measured using polymerase chain reaction (PCR). The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all subsequent visits.
Measured: 12 Months
Time to parasitological clearance based on serial PCR testing
Time to parasitological clearance based on PCR by treatment will be estimated using the Kaplan-Meier approach.
Measured: 12 Months
Presence or absence of seroreversion using conventional serology
Seroreversion as measured by conventional serology will be evaluated at 6 and 12-month study visits. Seroreversion is determined by the proportion of participants achieving serology changes from positive at baseline to negative at each time point.
Measured: At Month 6 and Month 12
Occurrence and severity of treatment emergent adverse events during the study
Incidence and severity of AEs by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs.
Measured: Up to 12 Months
Occurrence of adverse events resulting in treatment discontinuation
Incidence of AEs that result in treatment discontinuation.
Measured: Up to 12 Months
Occurrence of all-cause mortality through end of study visit
Incidence of death through the end of study visit.
Measured: Up to 48 Months
Maximum plasma concentration (Cmax) of LXE408
Cmax is defined as the maximum (peak) observed concentration following a dose.
Measured: At Day 1, 7, 14, 28
Time to maximum plasma concentration (Tmax) of LXE408
Tmax is defined as the time to reach maximum (peak) concentration following a dose.
Measured: At Day 1, 7, 14, 28
Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8)
AUC0-8 will be calculated by non-compartmental methods based on LXE408 plasma concentration data.
Measured: At Day 1, 7, 14, 28
Pre-dose concentration
Pre-dose concentration is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval.
Measured: At Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start28 Apr 2025
- Primary completion22 Jul 2027 (estimated)
- Study completion21 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632600
- Sponsor's protocol ID
- CLXE408B12201
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06632600
- Acronym / sponsor ID
- CLXE408B12201
- Conditions
- Chagas Disease
- Keywords
- LXE408, Chronic Chagas disease, Chronic indeterminate Chagas disease, Chronic Chagas disease without severe organ dysfunction, CICD, Chronic CD, Trypanosoma cruzi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 22 Jul 2027 (estimated)
- Study completion
- 21 Jan 2031 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LXE408 28 days | Experimental | –LXE408 administered by oral route |
| LXE408 14 days and Placebo 14 days | Experimental | Drug: LXE408, Drug: PlaceboLXE408 administered by oral route, followed by Placebo administered by oral route |
| Placebo 28 days | Placebo comparator | Drug: PlaceboPlacebo administered by oral route |
| Benznidazole 60 days | Active comparator | Drug: BenznidazoleBenznidazole administered by oral route |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LXE408LXE408 administered by oral route | Drug | LXE408 14 days and Placebo 14 days |
| PlaceboPlacebo administered by oral route | Drug | LXE408 14 days and Placebo 14 days, Placebo 28 days |
| BenznidazoleBenznidazole administered by oral route (administered as standard of care) | Drug | Benznidazole 60 days |
Primary outcome
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 28 days versus placebo.
Time frame: At Months 2, 4, and 6
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
13 secondary outcomes
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 -14 days versus placebo
Time frame: At Months 2, 4, and 6
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months-LXE408 - 28 days and 14 days versus benznidazone
Time frame: At Months 2, 4, and 6
Presence or absence of early parasitological clearance
Time frame: At Day 7, 14 and 28
Presence or absence of sustained parasitological clearance over 12 months by PCR testing
Time frame: 12 Months
Time to parasitological clearance based on serial PCR testing
Time frame: 12 Months
Presence or absence of seroreversion using conventional serology
Time frame: At Month 6 and Month 12
Occurrence and severity of treatment emergent adverse events during the study
Time frame: Up to 12 Months
Occurrence of adverse events resulting in treatment discontinuation
Time frame: Up to 12 Months
Occurrence of all-cause mortality through end of study visit
Time frame: Up to 48 Months
Maximum plasma concentration (Cmax) of LXE408
Time frame: At Day 1, 7, 14, 28
Time to maximum plasma concentration (Tmax) of LXE408
Time frame: At Day 1, 7, 14, 28
Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8)
Time frame: At Day 1, 7, 14, 28
Pre-dose concentration
Time frame: At Day 14 and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LXE408 and Benznidazole in people with Chagas Disease, run by Novartis Pharmaceuticals at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Argentina, Brazil, Colombia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 28 days versus placebo. (time frame: At Months 2, 4, and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.