Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
NCT ID: NCT05842954
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1720 participants
INTERVENTIONAL
2024-03-07
2025-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* The study duration will be 43 days (Core phase) plus up to 24 months (Extension phase).
* The treatment duration will be 3 days for each malaria episode.
* The visit frequency will be Days 1-3 (hospitalized) and 5 follow-up visits (Days 4, 8, 22, 29 and 43) in the Core phase and Days 1-3 (hospitalized) and 3 follow-up visits (Days 4, 8 and 29) in the Extension phase.
This study has two different primary outcomes depending on the submission (US New Drug Application (NDA) or non-US submissions).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
1. Once the first 200 patients (across both treatment arms) in the Core phase have been dosed and followed up to at least Day 22.
2. Once the first 750 patients (across both treatment arms) in the Core phase have been dosed and followed up to at least Day 22.
3. Additional DMC reviews may be conducted ad-hoc during the study, as deemed necessary.
All safety data from the Core phase as well as from the Extension phase that are available at these 2 scheduled timepoints will be included in the DMC reviews. After the database lock of the Core phase, the CTT will be unblinded.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
KLU156
KLU156 once daily (QD) for 3 days under fed conditions (light meal).
KLU156
Oral use. KLU156 (400/480 mg) is the dose for patients with a bodyweight ≥ 35kg. Patients \< 35kg will take a fraction of the dose according to weight group as defined in the protocol.
Coartem
Coartem twice a day (BID) for 3 days under fed conditions.
Coartem
Oral use. Dosing will be selected based on patient's body weight as per product's label.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
KLU156
Oral use. KLU156 (400/480 mg) is the dose for patients with a bodyweight ≥ 35kg. Patients \< 35kg will take a fraction of the dose according to weight group as defined in the protocol.
Coartem
Oral use. Dosing will be selected based on patient's body weight as per product's label.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
2 Months
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medicines for Malaria Venture (MMV), EDCTP, WANECAM
UNKNOWN
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Banfora, , Burkina Faso
Novartis Investigative Site
Bobo-Dioulasso, , Burkina Faso
Novartis Investigative Site
Nanoro, , Burkina Faso
Novartis Investigative Site
Ouagadougou, , Burkina Faso
Novartis Investigative Site
Sabou, , Burkina Faso
Novartis Investigative Site
Abidjan, , Côte d’Ivoire
Novartis Investigative Site
Agboville, , Côte d’Ivoire
Novartis Investigative Site
Azaguié, , Côte d’Ivoire
Novartis Investigative Site
Kimpese, Bas-Congo Province, Democratic Republic of the Congo
Novartis Investigative Site
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
Novartis Investigative Site
Lubumbashi, Du Haut Katanga, Democratic Republic of the Congo
Novartis Investigative Site
Kenge, Kwango, Democratic Republic of the Congo
Novartis Investigative Site
Masi-Manimba, Kwilu, Democratic Republic of the Congo
Novartis Investigative Site
Lambaréné, , Gabon
Novartis Investigative Site
Libreville, , Gabon
Novartis Investigative Site
Kintampo, , Ghana
Novartis Investigative Site
Navrango, , Ghana
Novartis Investigative Site
Kombewa, , Kenya
Novartis Investigative Site
Nairobi, , Kenya
Novartis Investigative Site
Siaya, , Kenya
Novartis Investigative Site
Sotouba, , Mali
Novartis Investigative Site
Niamey, , Niger
Novartis Investigative Site
Gicumbi, Northern Province, Rwanda
Novartis Investigative Site
Kigali, , Rwanda
Novartis Investigative Site
Kigali, , Rwanda
Novartis Investigative Site
Rubavu, , Rwanda
Novartis Investigative Site
Rusizi, , Rwanda
Novartis Investigative Site
Bagamoyo, , Tanzania
Novartis Investigative Site
Korogwe Tanga, , Tanzania
Novartis Investigative Site
Tanga, , Tanzania
Novartis Investigative Site
Tororo, , Uganda
Novartis Investigative Site
Nchelenge, Luapula Province, Zambia
Novartis Investigative Site
Ndola, , Zambia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-002675-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CKLU156A12301
Identifier Type: -
Identifier Source: org_study_id