Who is sponsoring NCT03167242?

NCT03167242 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03167242?

Interventions in NCT03167242: KAF156, Coartem, Lumefantrine Solid Dispersion Formulation.

What condition does NCT03167242 study?

NCT03167242 studies Acute Uncomplicated Plasmodium Falciparum Malaria.

Is NCT03167242 still recruiting?

NCT03167242 is currently completed. Last updated 10 February 2022.

Are results published for NCT03167242?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-02-10 · How we verify

NCT03167242

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Completed Phase 2 Results posted Last updated 10 February 2022

What this trial tests

Phase 2 trial testing KAF156 in Acute Uncomplicated Plasmodium Falciparum Malaria in 524 participants. Completed in 28 June 2021.

Timeline

2 August 2017

Primary endpoint
14 June 2021

28 June 2021

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	524
Start date	2 August 2017
Primary completion	14 June 2021
Estimated completion	28 June 2021
Sites	11 locations across Mali, Burkina Faso, Gabon, Vietnam, Mozambique, Thailand, Kenya, Uganda

Drugs / interventions tested

KAF156 — full drug profile →
Coartem (LUMEFANTRINE) — full drug profile →
Lumefantrine Solid Dispersion Formulation — full drug profile →

Conditions studied

Acute Uncomplicated Plasmodium Falciparum Malaria — all drugs for Acute Uncomplicated Plasmodium Falciparum Malaria →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

2 and older, any sex, with Acute Uncomplicated Plasmodium Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 Primary · 28 days post first dose

PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at Day 29 (i.e., 28 days post first dose) based on the short half-life of the study drugs. Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 29 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of p

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	46
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	45
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	47
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	47
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	44
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	42
Part A - Cohort 7: Coartem	25
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	37
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	42
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	38
Part B - Cohort 4: Coartem	21

PK Run-in: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Treatment Dose (AUC0-24h) of KAF156 Primary · 0, 1, 3, 6, 12, 18 and 24 hours post-dose

Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods.

Group	Value	95% CI
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day	5.35	± 34.8

Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Uncorrected Adequate Clinical and Parasitological Response (ACPR) Secondary · 14, 28 and 42 days post first dose

PCR-uncorrected ACPR defined as the absence of parasitaemia was evaluated at days 15, 29 and 43 (i.e., 14, 28 and 42 days post first dose). A participant was considered as PCR-uncorrected ACPR at Days 15, 29 or 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Days 15, 29 or 43 irrespective of axillary temperature.

Day 14 post first dose

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	49
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	47
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	51
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	53
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	50
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	51
Part A - Cohort 7: Coartem	27
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	51
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	52
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	43
Part B - Cohort 4: Coartem	24

Day 28 post first dose

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	46
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	40
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	48
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	51
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	45
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	47
Part A - Cohort 7: Coartem	26
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	34
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	41
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	36
Part B - Cohort 4: Coartem	15

Day 42 post first dose

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	42
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	36
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	45
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	45
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	41
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	45
Part A - Cohort 7: Coartem	19
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	29
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	33
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	31
Part B - Cohort 4: Coartem	11

Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) Secondary · 14 and 42 days post first dose

PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at days 15 and 43 (i.e., 14 and 42 days post first dose). Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 15 or Day 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 15 or Day 43 irrespective of axillary temperature unless the presence of parasitaemia a

Day 14 post first dose

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	48
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	46
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	48
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	47
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	44
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	43
Part A - Cohort 7: Coartem	25
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	47
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	45
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	40
Part B - Cohort 4: Coartem	22

Day 42 post first dose

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	45
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	44
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	46
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	46
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	43
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	41
Part A - Cohort 7: Coartem	24
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	36
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	37
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	37
Part B - Cohort 4: Coartem	20

Part A and Part B: Number of Participants With Recrudescence Events Secondary · 42 days post first dose

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 must be confirmed by PCR analysis.

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	4
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	3
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	1
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	1
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	0
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	2
Part A - Cohort 7: Coartem	0
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	12
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	7
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	3
Part B - Cohort 4: Coartem	2

Part A and Part B: Number of Participants With Reinfection Events Secondary · 42 days post first dose

Reinfection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection must be confirmed by PCR analysis.

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	3
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	7
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	4
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	7
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	8
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	2
Part A - Cohort 7: Coartem	8
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	11
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	10
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	9
Part B - Cohort 4: Coartem	10

Part A and Part B: Fever Clearance Time (FCT) Secondary · 42 days post first dose

Fever Clearance Time (FCT) is defined as the 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. In case a participant received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	18.7	± 3.09
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	22.5	± 6.09
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	20.3	± 4.92
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	16.6	± 3.48
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	17.5	± 2.65
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	19.2	± 2.92
Part A - Cohort 7: Coartem	26.3	± 7.67
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	23.5	± 10.26
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	17.3	± 7.4
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	13.8	± 3.68
Part B - Cohort 4: Coartem	22.9	± 12.78

PK Run-in, Part A and Part B: Parasite Clearance Time (PCT) Secondary · 42 days post first dose

Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a participant received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.

Group	Value	95% CI
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day	49.9	± 4.35
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	48.4	± 3.5
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	46.6	± 3.93
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	39.9	± 2.46
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	51.4	± 3.97
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	49.7	± 3.72
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	48.1	± 4.24
Part A - Cohort 7: Coartem	50.0	± 12.82
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	42.6	± 2.62
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	47.0	± 2.79
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	41.9	± 2.58
Part B - Cohort 4: Coartem	35.6	± 2.82

PK Run-in, Part A and Part B: Number of Participants With Parasitaemia Secondary · 12, 24 and 48 hours post last dose

Parasitaemia is the quantitative content of parasites in the blood determined by microscopy examination validated methods. Only Plasmodium Falciparum asexual form is used for parasitaemia assessments.

12 hours post last dose

Group	Value	95% CI
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day	12
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	46
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	46
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	44
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	52
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	49
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	49
Part A - Cohort 7: Coartem	22
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	48
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	48
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	42
Part B - Cohort 4: Coartem	22

24 hours post last dose

Group	Value	95% CI
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day	11
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	39
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	41
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	38
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	46
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	42
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	34
Part A - Cohort 7: Coartem	14
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	41
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	42
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	36
Part B - Cohort 4: Coartem	17

48 hours post last dose

Group	Value	95% CI
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day	3
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	13
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	9
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	8
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	12
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	10
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	11
Part A - Cohort 7: Coartem	4
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	4
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	10
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	5
Part B - Cohort 4: Coartem	1

Part A and Part B: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Last Treatment Dose (AUC0-24h) of KAF156 Secondary · 3, 6, 18 and 24 hours post last dose

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	9.84	± 41.5
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	21.7	± 41.7
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	9.95	± 131.9
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	5.91	± 29.2
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	11	± 79.3
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	10.9	± 57.4
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	11	± 47.7

Part A and Part B: Maximum Peak Observed Concentration (Cmax) of KAF156 Secondary · 3, 6, 18, 24, 27, 30, 48, 51, 54, 68, 72 and 168 hours post last dose

Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods.

Group	Value	95% CI
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	653	± 43.9
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	1470	± 46.5
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	1060	± 83.9
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	665	± 30.3
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	1470	± 30.9
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	1320	± 32.7
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	714	± 49.4
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days	1060	± 48.4
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days	1380	± 29.7

PK Run-in and Part A: Elimination Half-life (T½) of KAF156 Secondary · 0, 1, 3, 6, 12, 18, 24, 27, 30, 36, 48, 72, 96 and 168 hours post last dose

Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. T½ was determined using non-compartmental methods.

Group	Value	95% CI
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day	25.0	± 8.81
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day	25.4	± 5.32
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day	29.9	± 9.95
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days	31.0	± 3.86
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days	35.8	± 19.4
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days	28.4	± 3.49
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days	26.6	± 4.15

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from Day 1 to Day 43, where Day 43 could be 42, 41 or 40 days after end of treatment depending on whether the participant received treatment during 1, 2 or 3 consecutive days respectively.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PK Run-in: KAF 200 mg and LUM 960 mg QD for 1 Day

Serious: 0/12 (0%)

Deaths: 0/12

Part A: KAF 800 mg and LUM 960 mg QD for 1 Day

Serious: 1/51 (2%)

Deaths: 0/51

Part A: KAF 200 mg and LUM 480 mg QD for 3 Days

Serious: 2/54 (4%)

Deaths: 0/54

Part A: KAF 400 mg and LUM 480 mg QD for 3 Days

Serious: 1/51 (2%)

Deaths: 0/51

Part A and Part B: KAF 400 mg and LUM 960 mg QD for 1 Day

Serious: 7/103 (7%)

Deaths: 0/103

Part A and Part B: KAF 400 mg and LUM 960 mg QD for 2 Days

Serious: 5/104 (5%)

Deaths: 0/104

Part A and Part B: KAF 400 mg and LUM 960 mg QD for 3 Days

Serious: 2/97 (2%)

Deaths: 0/97

Part A and Part B: Coartem

Serious: 3/51 (6%)

Deaths: 0/51

Serious adverse events (13 terms)

Reaction	System	PK Run-in: KAF 200 mg and …	Part A: KAF 800 mg and LUM…	Part A: KAF 200 mg and LUM…	Part A: KAF 400 mg and LUM…	Part A and Part B: KAF 400…	Part A and Part B: KAF 400…	Part A and Part B: KAF 400…	Part A and Part B: Coartem
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Hepatitis acute	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Jaundice	Hepatobiliary disorders	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—
Plasmodium falciparum infection	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Aspartate aminotransferase	Investigations	—	—	—	—	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	PK Run-in: KAF 200 mg and …	Part A: KAF 800 mg and LUM…	Part A: KAF 200 mg and LUM…	Part A: KAF 400 mg and LUM…	Part A and Part B: KAF 400…	Part A and Part B: KAF 400…	Part A and Part B: KAF 400…	Part A and Part B: Coartem
Malaria	Infections and infestations	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Electrocardiogram QT prolonged	Investigations	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Sinus bradycardia	Cardiac disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Blood phosphorus increased	Investigations	—	—	—	—	—	—	—	—
Eosinophilia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Treatment failure	General disorders	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—
Infection parasitic	Infections and infestations	—	—	—	—	—	—	—	—

Most-reported serious reactions: Blood alkaline phosphatase increased, Blood bilirubin increased, Anaemia, Hepatitis acute, Jaundice, COVID-19, Plasmodium falciparum infection, Pneumonia.

Data from ClinicalTrials.gov NCT03167242 adverse events section.

Sponsor's own description

This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated Plasmodium falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance, and for duration shorter than 3 days of treatment and/or reduced pill burden.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The past, present and future of anti-malarial medicines.
Tse EG, Korsik M, Todd MH. · · 2019 · cited 260× · PMID 30902052 · DOI 10.1186/s12936-019-2724-z
Drugs in Development for Malaria.
Ashley EA, Phyo AP. · · 2018 · cited 123× · PMID 29802605 · DOI 10.1007/s40265-018-0911-9
MalDA, Accelerating Malaria Drug Discovery.
Yang T, Ottilie S, Istvan ES, Godinez-Macias KP, et al · · 2021 · cited 79× · PMID 33648890 · DOI 10.1016/j.pt.2021.01.009
Pan-active imidazolopiperazine antimalarials target the Plasmodium falciparum intracellular secretory pathway.
LaMonte GM, Rocamora F, Marapana DS, Gnädig NF, et al · · 2020 · cited 42× · PMID 32286267 · DOI 10.1038/s41467-020-15440-4
Recent updates in the discovery and development of novel antimalarial drug candidates.
Okombo J, Chibale K, Chibale K. · · 2018 · cited 38× · PMID 30108934 · DOI 10.1039/c7md00637c
Ganaplacide (KAF156) plus lumefantrine solid dispersion formulation combination for uncomplicated Plasmodium falciparum malaria: an open-label, multicentre, parallel-group, randomised, controlled, phase 2 trial.
Ogutu B, Yeka A, Kusemererwa S, Thompson R, et al · · 2023 · cited 34× · PMID 37327809 · DOI 10.1016/s1473-3099(23)00209-8
Fixed-Dose Combination Formulations in Solid Oral Drug Therapy: Advantages, Limitations, and Design Features.
Wilkins CA, Hamman H, Hamman JH, Steenekamp JH. · · 2024 · cited 25× · PMID 38399239 · DOI 10.3390/pharmaceutics16020178
Genomic and Genetic Approaches to Studying Antimalarial Drug Resistance and Plasmodium Biology.
Okombo J, Kanai M, Deni I, Fidock DA. · · 2021 · cited 19× · PMID 33715941 · DOI 10.1016/j.pt.2021.02.007

Verify or expand the search:

Other trials of KAF156

Trials testing the same drug.

NCT04546633 — Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in P · Phase 2 · completed
NCT04072302 — Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model · Phase 1 · completed

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Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03167242 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 10 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03167242.

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NCT03167242

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Results — posted to ClinicalTrials.gov

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Other trials of KAF156

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