Evaluating LXE408 for treating primary visceral leishmaniasis
A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis
This study is testing a new treatment called LXE408 to see if it can help adults and teens with primary visceral leishmaniasis feel better and stay safe during the process.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Drugs for Neglected Diseases Academic / other |
| Locations | 2 sites (Bihar and 1 other locations) |
| Trial ID | NCT05593666 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial is a multicenter, randomized, two-arm blinded study designed to assess the efficacy and safety of two regimens of LXE408 in patients with confirmed primary visceral leishmaniasis (VL). The study includes an open-label calibrator arm and aims to enroll adults and adolescents aged 12 years and older. Participants will be monitored for clinical outcomes and safety parameters throughout the treatment period. The trial is sponsored by Drugs for Neglected Diseases in collaboration with Novartis.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female patients aged 12 years and older with confirmed primary symptomatic visceral leishmaniasis.
Not a fit: Patients with severe clinical signs of VL or significant laboratory abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from primary visceral leishmaniasis.
How similar studies have performed: Other studies have shown promise in treating visceral leishmaniasis, but the specific approach of using LXE408 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients ≥ 18 years (at the time of the screening visit) who are able to comply with the study protocol. Following a favourable interim analysis result, patients ≥12 \<18 years will also be enrolled in the trial * Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parent(s) or legal guardian for patients under 18 years of age. In the case of minors, assent from the child also needs to be obtained * Primary symptomatic VL (defined as typical parameters including, but not limited to, fever for \> 2 weeks, weight loss, and splenomegaly) * Visualization of Leishmania amastigotes by microscopy in tissue samples (spleen or bone marrow) Exclusion Criteria: * Clinical signs of severe VL (jaundice, spontaneous bleeding, edema, ascites, coma, organ failure) * Laboratory abnormalities including ALT/SGPT \> 3 times ULN, total bilirubin \> 1.5 times ULN, creatinine \>1.5 times ULN, amylase or lipase \> 1.5 times ULN, haemoglobin \< 6 g/dL or other clinically significant abnormal laboratory parameters which, in the opinion of the investigator, may indicate severe VL * Patients with history of previous leishmaniasis and confirmed relapse * Patients with para-kala-azar dermal leishmaniasis * Patients with severe malnutrition (for children ≥12-\<18 years: BMI-for-age WHO reference curves by sex, z score \< -3; for adults ≥18 years: BMI \< 16) * History of congenital or acquired immunodeficiency, including positive HIV (test at screening) * Known hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome® * Concomitant infections such as tuberculosis, severe malaria, or any other serious underlying disease that may interfere with the disease assessment (e.g., cardiac, renal, hepatic, haematologic, and pancreatic) * Infection with hepatitis B (HBV) or hepatitis C virus (HCV). A positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a subject. Patients with a positive HCV antibody test should have HCV RNA levels measured. Patients with positive (detectable) HCV RNA should be excluded. * Pregnant or nursing (lactating) women * Women of childbearing potential who do not accept to have a pregnancy test done at screening and/or who do not agree to use highly effective contraception while taking the investigational drug and for 5 half-lives or 5 days, whichever is longer, after stopping the investigational drug. * Sexually active males unwilling to use a condom during intercourse while taking the investigational drug and for 5 half-lives or 5 days, whichever is longer, after stopping the investigational drug.
Where this trial is running
Bihar and 1 other locations
- DrugsNeglectedD Investigational Site — Bihar, India (Recruiting)
- DrugsNeglectedD Investigational Site — Patna, India (Recruiting)
Study contacts
- Study coordinator: Gwen Carn
- Email: gcarn@dndi.org
- Phone: +41 79 799 3886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.