A Phase 3 interventional study of KLU156 and Coartem in Uncomplicated Plasmodium Falciparum Malaria, sponsored by Novartis Pharmaceuticals. Completed at 32 sites in 12 countries. Open to participants aged 2 Months to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and 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.
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.
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.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 1,720 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Compared within Malaria, Falciparum, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Malaria. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Nov 4, 2026. See what changed
Key Inclusion criteria (Core phase)
Key Exclusion criteria (Core phase)
Any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KLU156 once daily (QD) for 3 days under fed conditions (light meal).
Drug: KLU156
Coartem twice a day (BID) for 3 days under fed conditions.
Drug: Coartem
KLU156 once daily (QD) for 3 days under fed conditions (light meal).
Drug: KLU156
Coartem twice a day (BID) for 3 days under fed conditions.
Drug: Coartem
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.
Oral use. Dosing was selected based on patient's body weight as per product's label.
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.
Time frame: 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.
Time frame: Day 29
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.
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
To confirm the efficacy of KLU156 by assessing uncorrected ACPR at additional time points.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 3
Core Phase: Gametocyte Clearance Time
To confirm the efficacy of KLU156 by assessing gametocyte clearance between the two treatment arms
Time frame: 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.
Time frame: 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.
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
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Up to approximately 18 months
Extension Phase: Gametocyte Carriage Over Time
To assess gametocyte carriage over time by malaria episode in the extension phase
Time frame: Up to Day 29 for each KLU156 treatment episode
| Milestone | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) | KLU156 (Participants With <10 kg Body Weight) | Coartem (Participants With <10 kg Body Weight |
|---|---|---|---|---|
| Started | 836 | 832 | 24 | 28 |
| Safety set | 830 | 831 | 24 | 27 |
| Modified randomized set (mras) | 836 | 832 | 0 | 0 |
| Modified safety set | 830 | 831 | 0 | 0 |
| Completed | 767 | 824 | 14 | 27 |
| Not completed | 69 | 8 | 10 | 1 |
| Withdrew: Not treated in core | 6 | 1 | 0 | 1 |
| Withdrew: Adverse event | 62 | 5 | 9 | 0 |
| Withdrew: Guardian decision | 1 | 1 | 0 | 0 |
| Withdrew: Protocol deviation | 0 | 1 | 0 | 0 |
| Withdrew: Technical problems | 0 | 0 | 1 | 0 |
| Milestone | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) | KLU156 (Participants With <10 kg Body Weight) | Coartem (Participants With <10 kg Body Weight |
|---|---|---|---|---|
| Started | 190 | 203 | 2 | 0 |
| Completed | 190 | 203 | 2 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Core Phase: PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | 97.4 (95.9 to 98.5) | 94.0 (92.0 to 95.7) |
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.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Core Phase: Uncorrected ACPR (US NDA Submission) at Day 29 | 85.3 (82.5 to 87.8) | 82.1 (79.1 to 84.9) |
To confirm the efficacy of KLU156 by assessing PCR-corrected ACPR at additional time points.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Day 22 n=664,713 | 98.9 (97.8 to 99.6) | 96.5 (94.9 to 97.7) |
| Day 43/End of Core Phase n=626,627 | 94.6 (92.5 to 96.2) | 91.7 (89.3 to 93.7) |
To confirm the efficacy of KLU156 by assessing uncorrected ACPR at additional time points.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Day 22 n=726,722 | 90.1 (87.7 to 92.2) | 92.1 (89.9 to 94.0) |
| Day 43/End of Core Phase n=726,722 | 74.4 (71.0 to 77.5) | 72.6 (69.2 to 75.8) |
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.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Day 8 to Day 22 n=667,711 | 0 | 0.8 |
| Day 23 to Day 29 n=658,680 | 0.4 | 2.2 |
| Day 30 to Day 43 n=626,615 | 1.9 | 0.8 |
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.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Day 8 to Day 22 n=667,711 | 0.5 | 2.7 |
| Day 23 to Day 29 n=657,674 | 2.2 | 6.8 |
| Day 30 to Day 43 n=625,608 | 10.6 | 10.5 |
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.
| hours | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Core Phase: Fever Clearance Time | 6.3 (6.0 to 11.6) | 11.9 (11.4 to 12.0) |
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.
| hours | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Core Phase: Parasite Clearance Time | 37.6 (36.2 to 46.9) | 36.0 (35.9 to 36.0) |
To confirm the efficacy of KLU156 by assessing gametocyte clearance between the two treatment arms
| hours | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Core Phase: Gametocyte Clearance Time | 35.9 (24.0 to 48.0) | 48.0 (36.0 to 159.7) |
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.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| 12 Hours n=719,721 | 96.9 (95.40 to 98.07) | 92.0 (89.72 to 93.84) |
| 24 Hours n=723,720 | 86.3 (83.58 to 88.73) | 62.5 (58.85 to 66.05) |
| 48 Hours n=721,721 | 15.0 (12.45 to 17.80) | 9.0 (7.03 to 11.35) |
| 72 Hours n=724,719 | 0.8 (0.30 to 1.80) | 1.7 (0.87 to 2.90) |
Assessed by microscopy. Baseline was pre-first dose administration.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Day 1: Present at 6 Hours | 4.4 | 4.7 |
| Day 1: Absent at 6 Hours | 94.1 | 95.3 |
| Day 1: Missing at 6 Hours | 1.5 | 0 |
| Day 1: Present at 12 Hours | 4.5 | 4.7 |
| Day 1: Absent at 12 Hours | 94.5 | 95.2 |
| Day 1: Missing at 12 Hours | 1.0 | 0.1 |
| Day 2: Present at 24 Hours | 3.9 | 6.2 |
| Day 2: Absent at 24 Hours | 95.7 | 93.5 |
| Day 2: Missing at 24 Hours | 0.4 | 0.3 |
| Day 2: Present at 36 Hours | 2.3 | 3.6 |
| Day 2: Absent at 36 Hours | 97.2 | 96.1 |
| Day 2: Missing at 36 Hours | 0.4 | 0.3 |
| Day 3: Present | 1.1 | 3.2 |
| Day 3: Absent | 98.8 | 96.7 |
| Day 3: Missing | 0.1 | 0.1 |
| Day 4: Present | 1.0 | 1.9 |
| Day 4: Absent | 98.8 | 97.6 |
| Day 4: Missing | 0.3 | 0.4 |
| Day 8: Present | 0.1 | 1.8 |
| Day 8: Absent | 99.2 | 97.0 |
| Day 8: Missing | 0.7 | 1.2 |
| Day 22: Present | 0 | 0.3 |
| Day 22: Absent | 97.8 | 97.5 |
| Day 22: Missing | 2.2 | 2.2 |
| Day 29: Present | 0 | 0.1 |
| Day 29: Absent | 97.1 | 97.1 |
| Day 29: Missing | 2.9 | 2.8 |
| Day 43/End of Core Phase: Present | 0.1 | 0.3 |
| Day 43/End of Core Phase: Absent | 97.2 | 96.8 |
| Day 43/End of Core Phase: Missing | 2.6 | 2.9 |
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).
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| All TEAEs | 53.5 | 50.8 |
| TEAEs of Grade 3 Severity or Higher | 2.5 | 2.8 |
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).
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) |
|---|---|---|
| Grade 2 | 0.2 | 0.6 |
| Grade 3 | 0.6 | 0.1 |
| Grade 4 | 0 | 0.2 |
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.
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) |
|---|---|
| 1st KLU156 Treatment n=342 | 98.0 (95.8 to 99.2) |
| 2nd KLU156 Treatment n=214 | 97.2 (94.0 to 99.0) |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) n=59 | 100.0 (93.9 to 100.0) |
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).
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) |
|---|---|
| 1st KLU156 Treatment n=362 | 86.5 (82.5 to 89.8) |
| 2nd KLU156 Treatment n=222 | 87.4 (82.3 to 91.5) |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) n=59 | 88.1 (77.1 to 95.1) |
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).
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) |
|---|---|
| 1st KLU156 Treatment n=393 | 12.2 |
| 2nd KLU156 Treatment n=230 | 9.1 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) n=62 | 11.3 |
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).
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) |
|---|---|
| 1st KLU156 Treatment n=393 | 0 |
| 2nd KLU156 Treatment n=230 | 0 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) n=62 | 0 |
To assess gametocyte carriage over time by malaria episode in the extension phase
| percentage of participants | KLU156 (Participants With ≥10 kg Body Weight) |
|---|---|
| 1st KLU156 Treatment, Present at Day 3 n=362 | 1.1 |
| 1st KLU156 Treatment, Absent at Day 3 n=362 | 98.9 |
| 2nd KLU156 Treatment Present at Day 3 n=222 | 0.5 |
| 2nd KLU156 Treatment Absent at Day 3 n=222 | 99.1 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) Present at Day 3 n=59 | 0 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) Absent at Day 3 n=59 | 100 |
| 1st KLU156 Treatment, Present at Day 4 n=362 | 0.8 |
| 1st KLU156 Treatment, Absent at Day 4 n=362 | 98.9 |
| 2nd KLU156 Treatment Present at Day 4 n=222 | 0 |
| 2nd KLU156 Treatment Absent at Day 4 n=222 | 100 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) Present at Day 4 n=59 | 0 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) Absent at Day 4 n=59 | 100 |
| 1st KLU156 Treatment, Present at Day 8 n=362 | 0 |
| 1st KLU156 Treatment, Absent at Day 8 n=362 | 99.4 |
| 2nd KLU156 Treatment Present at Day 8 n=222 | 0 |
| 2nd KLU156 Treatment Absent at Day 8 n=222 | 100 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) Present at Day 8 n=59 | 0 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) Absent at Day 8 n=59 | 100 |
| 1st KLU156 Treatment, Present at Day 29 n=362 | 0 |
| 1st KLU156 Treatment, Absent at Day 29 n=362 | 98.9 |
| 2nd KLU156 Treatment Present at Day 29 n=222 | 0 |
| 2nd KLU156 Treatment Absent at Day 29 n=222 | 99.1 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) Present at Day 29 n=59 | 0 |
| 3rd+ KLU156 Treatment Onward (includes 3rd, 4th, 5th, and 6th KLU156 groups) Absent at Day 29 n=59 | 100 |
Collected over Adverse events were reported from the first dose of study treatment until the end of study treatment plus a follow-up period, up to a maximum of approximately 20 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Core Phase: KLU156 (Participants With ≥10 kg Body Weight) | 0/830 (0%) | 7/830 (0.8%) | 361/830 (43.5%) |
| Core Phase: Coartem (Participants With ≥10 kg Body Weight) | 1/831 (0.1%) | 8/831 (1%) | 339/831 (40.8%) |
| Core Phase: Total (Participants With ≥10 kg Body Weight) | 1/1,661 (0.1%) | 15/1,661 (0.9%) | 700/1,661 (42.1%) |
| Extension Phase: KLU156 (Participants With ≥10 kg Body Weight) | 0/190 (0%) | 0/190 (0%) | 59/190 (31.1%) |
| Extension Phase: Coartem (Participants With ≥10 kg Body Weight) | 0/203 (0%) | 0/203 (0%) | 64/203 (31.5%) |
| Extension Phase: Total (Participants With ≥10 kg Body Weight) | 0/393 (0%) | 0/393 (0%) | 123/393 (31.3%) |
| Core Phase: KLU156 (Participants With <10 kg Body Weight) | 0/24 (0%) | 2/24 (8.3%) | 20/24 (83.3%) |
| Core Phase: Coartem (Participants With <10 kg Body Weight) | 0/27 (0%) | 2/27 (7.4%) | 16/27 (59.3%) |
| Core Phase: Total (Participants With <10 kg Body Weight) | 0/51 (0%) | 4/51 (7.8%) | 36/51 (70.6%) |
| Extension Phase: KLU156 (Participants With <10 kg Body Weight) | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Extension Phase: Coartem (Participants With <10 kg Body Weight) | — | — | — |
| Extension Phase: Total (Participants With <10 kg Body Weight) | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | Core Phase: KLU156 (Participants With ≥10 kg Body Weight) | Core Phase: Coartem (Participants With ≥10 kg Body Weight) | Core Phase: Total (Participants With ≥10 kg Body Weight) | Extension Phase: KLU156 (Participants With ≥10 kg Body Weight) | Extension Phase: Coartem (Participants With ≥10 kg Body Weight) | Extension Phase: Total (Participants With ≥10 kg Body Weight) | Core Phase: KLU156 (Participants With <10 kg Body Weight) | Core Phase: Coartem (Participants With <10 kg Body Weight) | Core Phase: Total (Participants With <10 kg Body Weight) | Extension Phase: KLU156 (Participants With <10 kg Body Weight) | Extension Phase: Coartem (Participants With <10 kg Body Weight) | Extension Phase: Total (Participants With <10 kg Body Weight) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/830 | 1/831 | 3/1661 | 0/190 | 0/203 | 0/393 | 1/24 | 0/27 | 1/51 | 0/2 | — | 0/2 |
| FuruncleInfections and infestations | 0/830 | 0/831 | 0/1661 | 0/190 | 0/203 | 0/393 | 1/24 | 0/27 | 1/51 | 0/2 | — | 0/2 |
| Hepatic enzyme increasedInvestigations | 0/830 | 0/831 | 0/1661 | 0/190 | 0/203 | 0/393 | 1/24 | 0/27 | 1/51 | 0/2 | — | 0/2 |
| DehydrationMetabolism and nutrition disorders | 0/830 | 0/831 | 0/1661 | 0/190 | 0/203 | 0/393 | 1/24 | 0/27 | 1/51 | 0/2 | — | 0/2 |
| MalariaInfections and infestations | 0/830 | 1/831 | 1/1661 | 0/190 | 0/203 | 0/393 | 0/24 | 1/27 | 1/51 | 0/2 | — | 0/2 |
| Liver function test increasedInvestigations | 0/830 | 0/831 | 0/1661 | 0/190 | 0/203 | 0/393 | 0/24 | 1/27 | 1/51 | 0/2 | — | 0/2 |
| Supraventricular tachycardiaCardiac disorders | 1/830 | 0/831 | 1/1661 | 0/190 | 0/203 | 0/393 | 0/24 | 0/27 | 0/51 | 0/2 | — | 0/2 |
| IntussusceptionGastrointestinal disorders | 1/830 | 0/831 | 1/1661 | 0/190 | 0/203 | 0/393 | 0/24 | 0/27 | 0/51 | 0/2 | — | 0/2 |
| VomitingGastrointestinal disorders | 1/830 | 0/831 | 1/1661 | 0/190 | 0/203 | 0/393 | 0/24 | 0/27 | 0/51 | 0/2 | — | 0/2 |
| CellulitisInfections and infestations | 1/830 | 0/831 | 1/1661 | 0/190 | 0/203 | 0/393 | 0/24 | 0/27 | 0/51 | 0/2 | — | 0/2 |
| Event | Core Phase: KLU156 (Participants With ≥10 kg Body Weight) | Core Phase: Coartem (Participants With ≥10 kg Body Weight) | Core Phase: Total (Participants With ≥10 kg Body Weight) | Extension Phase: KLU156 (Participants With ≥10 kg Body Weight) | Extension Phase: Coartem (Participants With ≥10 kg Body Weight) | Extension Phase: Total (Participants With ≥10 kg Body Weight) | Core Phase: KLU156 (Participants With <10 kg Body Weight) | Core Phase: Coartem (Participants With <10 kg Body Weight) | Core Phase: Total (Participants With <10 kg Body Weight) | Extension Phase: KLU156 (Participants With <10 kg Body Weight) | Extension Phase: Coartem (Participants With <10 kg Body Weight) | Extension Phase: Total (Participants With <10 kg Body Weight) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VomitingGastrointestinal disorders | 155/830 | 37/831 | 192/1661 | 19/190 | 16/203 | 35/393 | 15/24 | 2/27 | 17/51 | 2/2 | — | 2/2 |
| GastroenteritisInfections and infestations | 4/830 | 4/831 | 8/1661 | 0/190 | 3/203 | 3/393 | 1/24 | 0/27 | 1/51 | 1/2 | — | 1/2 |
| PyrexiaGeneral disorders | 74/830 | 104/831 | 178/1661 | 10/190 | 10/203 | 20/393 | 6/24 | 4/27 | 10/51 | 0/2 | — | 0/2 |
| MalariaInfections and infestations | 135/830 | 193/831 | 328/1661 | 23/190 | 21/203 | 44/393 | 1/24 | 4/27 | 5/51 | 0/2 | — | 0/2 |
| BronchitisInfections and infestations | 9/830 | 15/831 | 24/1661 | 5/190 | 3/203 | 8/393 | 2/24 | 5/27 | 7/51 | 0/2 | — | 0/2 |
| AnaemiaBlood and lymphatic system disorders | 68/830 | 69/831 | 137/1661 | 9/190 | 10/203 | 19/393 | 4/24 | 3/27 | 7/51 | 0/2 | — | 0/2 |
| CoughRespiratory, thoracic and mediastinal disorders | 17/830 | 13/831 | 30/1661 | 6/190 | 4/203 | 10/393 | 3/24 | 0/27 | 3/51 | 0/2 | — | 0/2 |
| RhinitisInfections and infestations | 21/830 | 16/831 | 37/1661 | 4/190 | 3/203 | 7/393 | 2/24 | 3/27 | 5/51 | 0/2 | — | 0/2 |
| DiarrhoeaGastrointestinal disorders | 4/830 | 3/831 | 7/1661 | 2/190 | 3/203 | 5/393 | 2/24 | 0/27 | 2/51 | 0/2 | — | 0/2 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 2/830 | 3/831 | 5/1661 | 0/190 | 0/203 | 0/393 | 2/24 | 1/27 | 3/51 | 0/2 | — | 0/2 |
| Age, Continuous(years) | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) | KLU156 (Participants With <10 kg Body Weight) | Coartem (Participants With <10 kg Body Weight) | Total |
|---|---|---|---|---|---|
| Mean | 12.13 ± 10.46 | 11.94 ± 9.91 | 1.60 ± 0.47 | 1.80 ± 0.60 | 11.73 ± 10.19 |
| Age, Customized(Participants) | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) | KLU156 (Participants With <10 kg Body Weight) | Coartem (Participants With <10 kg Body Weight) | Total |
|---|---|---|---|---|---|
| Infants and toddlers (28 days-23 months) | 13 | 9 | 18 | 13 | 53 |
| Children (2-11 years) | 506 | 515 | 6 | 14 | 1041 |
| Adolescents (12-17 years) | 162 | 152 | 0 | 0 | 314 |
| Adults (18-64 years) | 152 | 155 | 0 | 0 | 307 |
| From 65-84 years | 3 | 1 | 0 | 0 | 4 |
| Sex: Female, Male(Participants) | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) | KLU156 (Participants With <10 kg Body Weight) | Coartem (Participants With <10 kg Body Weight) | Total |
|---|---|---|---|---|---|
| Female | 419 | 395 | 15 | 14 | 843 |
| Male | 417 | 437 | 9 | 13 | 876 |
| Race/Ethnicity, Customized(Participants) | KLU156 (Participants With ≥10 kg Body Weight) | Coartem (Participants With ≥10 kg Body Weight) | KLU156 (Participants With <10 kg Body Weight) | Coartem (Participants With <10 kg Body Weight) | Total |
|---|---|---|---|---|---|
| Black or African American | 816 | 813 | 24 | 27 | 1680 |
| Race Not Reported | 19 | 19 | 0 | 0 | 38 |
| Race Unknown | 1 | 0 | 0 | 0 | 1 |
| Not Hispanic or Latino | 755 | 746 | 24 | 27 | 1552 |
| Ethnicity Not reported | 81 | 86 | 0 | 0 | 167 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: KLU156