LXE408 for Chagas Disease

Recruiting at 19 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Benznidazole

Disqualifiers: Acute CD, Cardiovascular, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2-8 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, LXE408, to determine if it can reduce or eliminate the parasites causing chronic Chagas disease, a serious illness affecting the heart and digestive system. Participants will receive either LXE408, a standard treatment called benznidazole, or a placebo (a non-active substance). The trial aims to assess the effectiveness and safety of LXE408 for treating this condition. Individuals with chronic Chagas disease who do not have severe heart or digestive issues might be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in Chagas disease treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you cannot use medications that are prohibited by the study. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LXE408 has been tested for safety in healthy individuals. These studies found LXE408 to be generally safe and well-tolerated at various doses, including up to 600 mg, without serious side effects.

For those considering joining the trial, these results suggest that LXE408 might be well-tolerated in humans. However, as it remains under study, unexpected side effects may occur. It is important to consult a healthcare provider before making any decisions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Chagas disease?

Unlike the standard treatments for Chagas disease, such as Benznidazole, which require a full 60-day course, LXE408 is exciting because it might offer a shorter treatment duration. This investigational drug is administered orally and is being tested in regimens as short as 14 days. Researchers are particularly interested in LXE408 because it may target the parasite causing Chagas disease in a novel way, potentially leading to quicker and more effective outcomes. The possibility of a more convenient and potentially more effective treatment is what makes LXE408 stand out.

What evidence suggests that this trial's treatments could be effective for Chagas disease?

Research is investigating how LXE408, a treatment in this trial, might reduce or eliminate the parasites causing chronic Chagas disease. This treatment targets these parasites in the blood. Early results from studies on similar diseases suggest effectiveness, but specific data for LXE408 in Chagas disease is still being collected. This trial compares LXE408 to benznidazole, an existing treatment for Chagas, and a placebo. While there is hope for LXE408's effectiveness, further research is needed to confirm its benefits. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic Chagas disease who can understand and consent to the study. They must be able to take benznidazole according to local guidelines, communicate well with researchers, and comply with study requirements. Participants should not have severe organ damage due to Chagas.

Inclusion Criteria

I have been diagnosed with T. cruzi infection.

I have signed and understand the consent form for this study.

I am eligible and can follow the treatment plan for benznidazole as per local guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either LXE408 or placebo for 14 to 28 days, or benznidazole for 60 days

2-8 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including parasitological clearance and adverse events

12 months

Regular visits at 2, 4, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• LXE408

Trial Overview The trial is testing LXE408's effectiveness in reducing or eliminating parasites in the blood of those with chronic Chagas disease. It will compare LXE408 against a placebo and the standard treatment, benznidazole.

How Is the Trial Designed?

Group I: LXE408 28 days Experimental Treatment 1 Intervention

LXE408 administered by oral route

Group II: LXE408 14 days and Placebo 14 days Experimental Treatment 2 Interventions

LXE408 administered by oral route, followed by Placebo administered by oral route

Group III: Benznidazole 60 days Active Control 1 Intervention

Benznidazole administered by oral route

Group IV: Placebo 28 days Placebo Group 1 Intervention

Placebo administered by oral route

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06632600?term=AREA%5BConditionSearch%5D(Chagas%20Disease)%20AND%20AREA%5BOverallStatus%5D(RECRUITING)&rank=1

NCT06632600 | A Study of Efficacy, Safety, Tolerability of ... This study is to investigate the ability of LXE408 to reduce or remove the level of parasites in the blood of people with chronic Chagas disease. Participants ...

2. dndi.org dndi.org/wp-content/uploads/2023/10/DNDi-LXE408-01-VL-Clinical-Trial-Protocol-Synopsis.pdf

Clinical trial protocol synopsis: LXE408 Phase 2 Purpose of the Phase 2 clinical trial: This study aims to assess the efficacy, safety and PK profile of LXE408 in primary VL patients in India. A SDA arm will ...

3. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.0c00499

Discovery and Characterization of Clinical Candidate LXE408 ... At D210, definitive cure was 87% (95% CI: 77-97) for AmBisome + SSG, 77% (95% CI 64-90) for AmBisome + miltefosine and 72% (95% CI 60-85) for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10277022/

State-of-the-Art in the Drug Discovery Pathway for Chagas ... We present a framework to guide drug discovery efforts against Chagas disease, considering state-of-the-art preclinical models and recently developed tools.

5. novartis.com novartis.com/clinicaltrials/study/nct06632600

A Study of Efficacy, Safety, Tolerability of LXE408 in ... This study is to investigate the ability of LXE408 to reduce or remove the level of parasites in the blood of people with chronic Chagas disease.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666524724002337

Challenges and advancements in the development of ... With an estimated 6–7 million individuals infected with T cruzi worldwide, the disease often leads to severe cardiac and gastrointestinal complications. Despite ...