Uncomplicated Plasmodium Falciparum MalariaPhase 3KALUMANCT05842954
Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
A Phase 3 study testing KLU156 and Coartem in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 32 sites in 12 countries.
Trial summary
This study aimed to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 10 kg of body weight suffering from uncomplicated P. Read more about this study
- Who is it for?
- Ages 2 months to 100 years
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- KLU156 and Coartem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,720 participants
- Where
- 32 sitesin 12 countries
- Study dates
- 7 Mar 2024to 25 Nov 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 months to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients ≥ 10 kg of body weight.
- 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.
- 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)
- Negative pregnancy test for patients of childbearing potential
- Signed informed consent was obtained before any assessment is performed; for minors, signed informed consent was obtained from parent/legal guardian. If the parent/legal guardian was unable to read and write, then a witnessed consent according to local ethical standards was permitted. Patients who were capable of providing assent, must have provided it along with parent/legal guardian consent or as per local ethical standards
- The patient and/or their parent/legal guardian was able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and was likely to complete the study as planned.
Who cannot join
- Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization)
- Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19)
- 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)
- 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)
- Clinically relevant abnormalities of electrolyte balance which required correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia
- Anemia (hemoglobin level <7 g/dL)
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- Any surgical or medical condition which might have significantly altered 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 have jeopardized the patient in case of participation in the study.
- 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
- 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 was unknown)
- 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
- Pregnant or nursing (lactating) patients.
Trial locations and contacts
32 sites in 12 countries.
32 sites in 12 countries
Burkina Faso5 sites
Novartis Investigative Site
Banfora
Novartis Investigative Site
Bobo-Dioulasso
Novartis Investigative Site
Nanoro, BP 18
Novartis Investigative Site
Ouagadougou
Novartis Investigative Site
Sabou
Democratic Republic of the Congo5 sites
Novartis Investigative Site
Kenge, Kwango
Novartis Investigative Site
Kimpese, Bas-Congo Province
Novartis Investigative Site
Kisantu, Bas-Congo Province
Novartis Investigative Site
Lubumbashi, Du Haut Katanga, 7010
Novartis Investigative Site
Masi-Manimba, Kwilu
Rwanda4 sites
Novartis Investigative Site
Gicumbi, Northern Province
Novartis Investigative Site
Kigali
Novartis Investigative Site
Rubavu
Novartis Investigative Site
Rusizi
Côte d’Ivoire3 sites
Novartis Investigative Site
Abidjan, 13 BP 972
Novartis Investigative Site
Agboville
Novartis Investigative Site
Azaguié
Kenya3 sites
Novartis Investigative Site
Kombewa, 40102
Novartis Investigative Site
Nairobi, 00200
Novartis Investigative Site
Siaya, 2300
Tanzania3 sites
Novartis Investigative Site
Bagamoyo, 78373
Novartis Investigative Site
Korogwe Tanga, 9653
Novartis Investigative Site
Tanga, 5004
Gabon2 sites
Novartis Investigative Site
Lambaréné, BP 242
Novartis Investigative Site
Libreville, BP 1437
Ghana2 sites
Novartis Investigative Site
Kintampo, 92037
Novartis Investigative Site
Navrango, VWJ6+8WF
Zambia2 sites
Novartis Investigative Site
Nchelenge, Luapula Province, 70100
Novartis Investigative Site
Ndola, 71769
About this study
Official title: 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 Followed by an Extension Phase With Repeated KLU156 Treatment
This study aimed to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 10 kg of body weight suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection).
In the extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 was assessed for a maximum of approximately 18 months 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.
Read the detailed description
The purpose of this study was to confirm the efficacy, safety and tolerability of KLU156 in patients with uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection) by demonstrating that KLU156 is non-inferior to Coartem.
- The total study duration was up to approximately 20 months.
- The treatment duration was 3 days for each malaria episode.
- The visit frequency was 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 had two different primary outcomes depending on the submission (US New Drug Application (NDA) or non-US submissions).
Protocol amendment 01 increased the minimum body weight requirement for study participation from ≥ 5 kg to ≥ 10 kg and revised the statistical analysis plan to exclude patients < 10 kg from the main analyses.
- Being tested
- KLU156, Coartem
- Keywords
- malaria, Plasmodium falciparum, KLU156, Coartem, artemether, lumefantrine, ganaplacide
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLU156Drug
Oral use. KLU156 (400/480 mg) was the dose for patients with a bodyweight ≥ 35kg. Patients < 35kg took a fraction of the dose according to weight group as defined in the protocol.
CoartemDrug
Oral use. Dosing was selected based on patient's body weight as per product's label.
| Study group | Role | What they receive |
|---|---|---|
| KLU156 | Experimental | KLU156 once daily (QD) for 3 days under fed conditions (light meal). Receives: Drug: KLU156 |
| Coartem | Active comparator | Coartem twice a day (BID) for 3 days under fed conditions. Receives: Drug: Coartem |
| KLU156 (Participants with <10 kg Body Weight) | Experimental | KLU156 once daily (QD) for 3 days under fed conditions (light meal). Receives: Drug: KLU156 |
| Coartem (Participants with <10 kg Body Weight) | Active comparator | Coartem twice a day (BID) for 3 days under fed conditions. Receives: Drug: Coartem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Phase: PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29
PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 is defined as the percentage of participants who are clinically well and have no recrudescence (reappearance of the original malaria infection) by 29 days after treatment, with PCR genotyping used to distinguish new infections from recrudescence. This primary outcome was applicable to the non-US submission.
Measured: Day 29 (i.e., 28 days post-first dose administration)
Core Phase: Uncorrected ACPR (US NDA Submission) at Day 29
Uncorrected ACPR at Day 29 is defined as the percentage of participants who are clinically well and have no malaria parasite reappearance detected by Day 29 after treatment, without using parasite genotyping to distinguish new infections from recrudescence of the original infection. This primary outcome was applicable to US New Drug Application (NDA) submission.
Measured: Day 29
Secondary outcomes (16)
Core Phase: PCR-corrected ACPR at Days 22 and 43
To confirm the efficacy of KLU156 by assessing PCR-corrected ACPR at additional time points.
Measured: Days 22 and 43 (i.e., 21 and 42 days post-first dose administration)
Core Phase: Uncorrected ACPR at Days 22 and 43
To confirm the efficacy of KLU156 by assessing uncorrected ACPR at additional time points.
Measured: Days 22 and 43 (i.e., 21 and 42 days post-first dose administration)
Core Phase: Percentage of Participants With Recrudescence
Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence had to be confirmed by PCR analysis.
Measured: Days 22, 29 and 43
Core Phase: Percentage of Participants With New Infection
New infection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. New infection had to be confirmed by PCR analysis.
Measured: Days 22, 29 and 43
Core Phase: Fever Clearance Time
Fever clearance time is defined as time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours.
Measured: Up to Day 3
Core Phase: Parasite Clearance Time
Parasite clearance time is defined as time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours.
Measured: Up to Day 3
Core Phase: Gametocyte Clearance Time
To confirm the efficacy of KLU156 by assessing gametocyte clearance between the two treatment arms
Measured: Up to Day 3
Core Phase: Percentage of Participants With Parasitemia
For the parasitemia assessment, blood sampling can be done by means of a finger prick except when the timing for parasitology assessments coincides with time for clinical laboratory tests, in which case, blood sample can be taken from the venous blood collected for clinical laboratory analyses.
Measured: 12, 24, 48 and 72 hours after treatment
Core Phase: Clearance of Gametocytes in Participants With Gametocytemia at Baseline
Assessed by microscopy. Baseline was pre-first dose administration.
Measured: From baseline up to Day 43
Core Phase: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Grade 3 Severity or Higher
Incidence and severity of TEAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs), and laboratory results qualifying and reported as AEs. Severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death).
Measured: Day 43
Core Phase: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs), Graded by Severity
Incidence and severity of treatment-emergent SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs), and laboratory results qualifying and reported as AEs. Severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death).
Measured: Day 43
Extension Phase: PCR-corrected ACPR
To evaluate PCR-corrected ACPR over repeated treatment with KLU156 in adults and children ≥ 10 kg of body weight suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection). Patients were instructed to return to the study site whenever symptoms suggestive of malaria occurred. At each suspected malaria episode, eligibility for KLU156 treatment was reassessed, including confirmation of malaria diagnosis.
Measured: Up to Day 29 for each KLU156 treatment episode
Extension Phase: Uncorrected ACPR
To evaluate uncorrected ACPR over repeated treatment with KLU156 in adults and children ≥ 10 kg of body weight suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection).
Measured: Up to Day 29 for each KLU156 treatment episode
Extension Phase: Percentage of Participants With KLU156-related AEs by Malaria Episode
To assess the safety and tolerability over repeated treatment with KLU156 in adults and children ≥ 10 kg of body weight suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection).
Measured: Up to approximately 18 months
Extension Phase: Percentage of Participants With SAEs by Severity and Malaria Episode
To assess the safety and tolerability over repeated treatment with KLU156 in adults and children ≥ 10 kg of body weight suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection).
Measured: Up to approximately 18 months
Extension Phase: Gametocyte Carriage Over Time
To assess gametocyte carriage over time by malaria episode in the extension phase
Measured: Up to Day 29 for each KLU156 treatment episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Mar 2024
- Primary completion27 Jun 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uncomplicated Plasmodium Falciparum MalariaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture (MMV), EDCTP, WANECAM
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842954
- Sponsor's protocol ID
- CKLU156A12301
- Other IDs
- 2022-002675-10
- Acronym
- KALUMA
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2023
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Followed by an Extension Phase With Repeated KLU156 Treatment
- ClinicalTrials.gov ID
- NCT05842954
- Acronym / sponsor ID
- KALUMA / CKLU156A12301
- Keywords
- malaria, Plasmodium falciparum, KLU156, Coartem, artemether, lumefantrine, ganaplacide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,720 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture (MMV), EDCTP, WANECAM
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 10 kg of body weight suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection).
In the extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 was assessed for a maximum of approximately 18 months 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
The purpose of this study was to confirm the efficacy, safety and tolerability of KLU156 in patients with uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection) by demonstrating that KLU156 is non-inferior to Coartem.
- The total study duration was up to approximately 20 months.
- The treatment duration was 3 days for each malaria episode.
- The visit frequency was 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 had two different primary outcomes depending on the submission (US New Drug Application (NDA) or non-US submissions).
Protocol amendment 01 increased the minimum body weight requirement for study participation from ≥ 5 kg to ≥ 10 kg and revised the statistical analysis plan to exclude patients < 10 kg from the main analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KLU156 | Experimental | Drug: KLU156KLU156 once daily (QD) for 3 days under fed conditions (light meal). |
| Coartem | Active comparator | Drug: CoartemCoartem twice a day (BID) for 3 days under fed conditions. |
| KLU156 (Participants with <10 kg Body Weight) | Experimental | Drug: KLU156KLU156 once daily (QD) for 3 days under fed conditions (light meal). |
| Coartem (Participants with <10 kg Body Weight) | Active comparator | Drug: CoartemCoartem twice a day (BID) for 3 days under fed conditions. |
Who may qualify
- Ages
- 2 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients ≥ 10 kg of body weight.
- 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.
- 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)
- Negative pregnancy test for patients of childbearing potential
- Signed informed consent was obtained before any assessment is performed; for minors, signed informed consent was obtained from parent/legal guardian. If the parent/legal guardian was unable to read and write, then a witnessed consent according to local ethical standards was permitted. Patients who were capable of providing assent, must have provided it along with parent/legal guardian consent or as per local ethical standards
Key exclusion criteria (14 listed)
- Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization)
- Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19)
- 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)
- 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)
- Clinically relevant abnormalities of electrolyte balance which required correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia
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 |
|---|---|---|
| KLU156Oral use. KLU156 (400/480 mg) was the dose for patients with a bodyweight ≥ 35kg. Patients < 35kg took a fraction of the dose according to weight group as defined in the protocol. | Drug | KLU156, KLU156 (Participants with <10 kg Body Weight) |
| CoartemOral use. Dosing was selected based on patient's body weight as per product's label. | Drug | Coartem, Coartem (Participants with <10 kg Body Weight) |
Primary outcome
Core Phase: PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29
Time frame: Day 29 (i.e., 28 days post-first dose administration)
PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 is defined as the percentage of participants who are clinically well and have no recrudescence (reappearance of the original malaria infection) by 29 days after treatment, with PCR genotyping used to distinguish new infections from recrudescence. This primary outcome was applicable to the non-US submission.
Core Phase: Uncorrected ACPR (US NDA Submission) at Day 29
Time frame: Day 29
Uncorrected ACPR at Day 29 is defined as the percentage of participants who are clinically well and have no malaria parasite reappearance detected by Day 29 after treatment, without using parasite genotyping to distinguish new infections from recrudescence of the original infection. This primary outcome was applicable to US New Drug Application (NDA) submission.
16 secondary outcomes
Core Phase: PCR-corrected ACPR at Days 22 and 43
Time frame: Days 22 and 43 (i.e., 21 and 42 days post-first dose administration)
Core Phase: Uncorrected ACPR at Days 22 and 43
Time frame: Days 22 and 43 (i.e., 21 and 42 days post-first dose administration)
Core Phase: Percentage of Participants With Recrudescence
Time frame: Days 22, 29 and 43
Core Phase: Percentage of Participants With New Infection
Time frame: Days 22, 29 and 43
Core Phase: Fever Clearance Time
Time frame: Up to Day 3
Core Phase: Parasite Clearance Time
Time frame: Up to Day 3
Core Phase: Gametocyte Clearance Time
Time frame: Up to Day 3
Core Phase: Percentage of Participants With Parasitemia
Time frame: 12, 24, 48 and 72 hours after treatment
Core Phase: Clearance of Gametocytes in Participants With Gametocytemia at Baseline
Time frame: From baseline up to Day 43
Core Phase: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Grade 3 Severity or Higher
Time frame: Day 43
Core Phase: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs), Graded by Severity
Time frame: Day 43
Extension Phase: PCR-corrected ACPR
Time frame: Up to Day 29 for each KLU156 treatment episode
Extension Phase: Uncorrected ACPR
Time frame: Up to Day 29 for each KLU156 treatment episode
Extension Phase: Percentage of Participants With KLU156-related AEs by Malaria Episode
Time frame: Up to approximately 18 months
Extension Phase: Percentage of Participants With SAEs by Severity and Malaria Episode
Time frame: Up to approximately 18 months
Extension Phase: Gametocyte Carriage Over Time
Time frame: Up to Day 29 for each KLU156 treatment episode
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KLU156 and Coartem in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 32 sites in 12 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 14 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Burkina Faso, Democratic Republic of the Congo, Rwanda, Côte d’Ivoire, Kenya and 7 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Phase: PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 (time frame: Day 29 (i.e., 28 days post-first dose administration)). The study lists 2 primary outcomes in all. 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 4 Nov 2026.