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Testing KLU156 for treating uncomplicated malaria in adults and children

A Randomized, Open-label, Multicenter Study to Compare Efficacy, Safety and Tolerability of KLU156 With Coartem® in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Adults and Children ≥ 5 kg Body Weight Followed by an Extension Phase With Repeated KLU156 Treatment

Phase 3 Interventional Novartis · NCT05842954

This study is testing a new malaria treatment called KLU156 to see if it works as well as the standard treatment for adults and children with uncomplicated malaria.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1500 (estimated)
Ages2 Months to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations36 sites (Banfora and 35 other locations)
Trial IDNCT05842954 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and tolerability of KLU156, a combination of ganaplacide and lumefantrine, in treating uncomplicated Plasmodium falciparum malaria in patients aged 2 months and older. Participants will receive the treatment once daily for three days, with follow-up assessments to monitor their health and response to the medication. The study includes a core phase lasting 43 days and an extension phase of up to 24 months for those who tolerate the treatment well. The goal is to demonstrate that KLU156 is as effective as the standard treatment, Coartem.

Who should consider this trial

Good fit: Ideal candidates are adults and children aged 2 months and older with a confirmed diagnosis of uncomplicated P. falciparum malaria.

Not a fit: Patients with severe malaria or those who have experienced early treatment failure with previous malaria treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer option for patients suffering from uncomplicated malaria.

How similar studies have performed: Other studies have shown success with similar combination therapies for malaria, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion criteria (Core phase)

1. Male or female patients ≥ 5 kg of body weight and ≥ 2 months of age
2. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia ≥ 1,000 and ≤ 200,000 parasites/µL at the time of pre-screening with or without other Plasmodium spp. co-infection.
3. Axillary temperature ≥ 37.5 ºC or oral temperature ≥ 38.0 ºC or tympanic/rectal temperature ≥ 38.5 ºC; or history of fever during the previous 24 hours (at least documented verbally)
4. Negative pregnancy test for patients of childbearing potential
5. Signed informed consent must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian. If the parent/legal guardian is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide it along with parent/legal guardian consent or as per local ethical standards
6. The patient and/or their parent/legal guardian is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.

Key Exclusion criteria (Core phase)

1. Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization)
2. Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19)
3. Severe malnutrition. For patients ≥ 12 years: body mass index (BMI) \< 16.0. For children \< 12 years: less than 70% of median normalized WHO reference weight or very low mid-upper arm circumference (MUAC \< 115 mm)
4. Repeated vomiting (defined as \> 3 times in the 24 hours prior to start of screening) or severe diarrhea (defined as \> 3 watery stools in the 24 hours prior to start of screening)
5. Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia
6. Anemia (hemoglobin level \<7 g/dL)
7. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., Human immunodeficiency virus (HIV) patients on antiretroviral therapy (ART) or tuberculosis (TB) patients on treatment), or which may jeopardize the patient in case of participation in the study.
8. Any of the following:

   * Aspartate Aminotransferase/ Alanine Aminotransferase (AST/ALT) \> 3 x the upper limit of normal (ULN), regardless of the level of total bilirubin
   * Total bilirubin \> 3 x ULN
   * Resting QT interval corrected by Fridericia's formula (QTcF) \> 450 ms at screening
9. Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life is unknown)
10. History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease
11. Pregnant or nursing (lactating) patients.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Banfora and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Uncomplicated Plasmodium Falciparum MalariamalariaPlasmodium falciparumKLU156Coartemartemetherlumefantrineganaplacide
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.