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    Clinical Trial Results:
    A multicenter, open-label, single-arm study to evaluate the PK, safety, tolerability and efficacy of a new artemether-lumefantrine (2.5 mg: 30 mg) dispersible tablet in the treatment of infants and neonates <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria

    Summary
    EudraCT number
    		 2023-000804-21
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Nov 2024
    First version publication date
    01 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCOA566B2307
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04300309
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland, CH-4056
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the key pharmacokinetics (PK) parameter of artemether in infants and neonates < 5 kg body weight dosed with the new formulation of artemether-lumefantrine dispersible tablet.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Burkina Faso: 7
    Country: Number of subjects enrolled
    Congo, The Democratic Republic of the: 21
    Worldwide total number of subjects
    28
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    6
    Infants and toddlers (28 days-23 months)
    22
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 3 investigative sites in 2 countries.

    Pre-assignment
    Screening details
    		 The Screening procedures began once the study informed consent had been obtained. Screening was performed within 12 hours before the first study drug administration.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 Infants >28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    artemether-lumefantrine
    Investigational medicinal product code
    COA566
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The investigational product was artemether-lumefantrine 2.5 mg:30 mg (COA566 2.5 mg:30 mg), supplied in the form of oral dispersible tablets. The study treatment was 2 oral dispersible tablets (i.e. artemether-lumefantrine 5 mg:60 mg), twice daily, for 3 days.

    Arm title
    		 Cohort 2
    Arm description
    		 Term neonates 1-28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    artemether-lumefantrine
    Investigational medicinal product code
    COA566
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The investigational product was artemether-lumefantrine 2.5 mg:30 mg (COA566 2.5 mg:30 mg), supplied in the form of oral dispersible tablets. The study treatment was 2 oral dispersible tablets (i.e. artemether-lumefantrine 5 mg:60 mg), twice daily, for 3 days.

    Number of subjects in period 1
    		Cohort 1 Cohort 2
    Started
    22
    6
    Full Analysis Set (FAS)
    22
    6
    Per-Protocol Set (PPS)
    17 [1]
    6
    PK Set
    22
    6
    Completed treatment phase
    22
    6
    Completed Core follow-up (43 days)
    22
    6
    Completed
    21
    6
    Not completed
    1
    0
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: FAS, PPS and PK Set are analysis sets

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Infants >28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days

    Reporting group title
    Cohort 2
    Reporting group description
    		 Term neonates 1-28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days

    Reporting group values
    		 Cohort 1 Cohort 2 Total
    Number of subjects
    		 22 6 28
    Age Categorical
    Units: participants
        1-7 days
    		 0 1 1
        8-14 days
    		 0 0 0
        15-28 days
    		 0 5 5
        >28 days
    		 22 0 22
    Age Continuous
    Units: days
        median (full range (min-max))
    		 96.0 (53.0 to 157.0) 22.5 (1.0 to 26.0) -
    Sex: Female, Male
    Units: participants
        Female
    		 15 3 18
        Male
    		 7 3 10
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 22 6 28
    Plasmodium species
    Parasitemia determinations were performed in peripheral blood. Microscopic species determination was confirmed with polymerase chain reaction (PCR)-based methods. The assessments were performed at a central reference laboratory.
    Units: Subjects
        P. falciparum asexual forms
    		 21 6 27
        P. vivax
    		 0 0 0
        P. ovale
    		 0 0 0
        P. malariae
    		 1 0 1
        P. knowlesi
    		 0 0 0
    Plasmodium falciparum density
    Parasitemia determinations were performed in peripheral blood. Giemsa stained thick fields were examined at a central reference laboratory. The parasite density was calculated according to the following formula: (number of Plasmodium falciparum parasites * actual leukocytes)/number of leucocytes counted (200 thick films fields examined)
    Units: parasites/µL
        median (full range (min-max))
    		 8400 (748 to 156400) 3660 (384 to 52700) -
    Weight
    Units: kilograms
        median (full range (min-max))
    		 4.82 (3.89 to 4.98) 3.50 (2.80 to 4.24) -

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Infants >28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days

    Reporting group title
    Cohort 2
    Reporting group description
    		 Term neonates 1-28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days

    Primary: Artemether Cmax after first dose

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    End point title
    		 Artemether Cmax after first dose [1]
    End point description
    Artemether Cmax represents the highest concentration between the concentrations at 1 hour and 2 hours after first dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on artemether plasma concentrations.
    End point type
    Primary
    End point timeframe
    1 and 2 hours after first dose (Day 1)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    20
    5
    Units: ng/mL
        geometric mean (confidence interval 90%)
    68.0 (45.1 to 103)
    62.2 (33.6 to 115)
    No statistical analyses for this end point

    Secondary: Lumefantrine Day 8 concentration (C168h)

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    End point title
    		 Lumefantrine Day 8 concentration (C168h)
    End point description
    Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on lumefantrine plasma concentrations. Dosing times were 0, 8, 24, 36, 48 and 60 hours.
    End point type
    Secondary
    End point timeframe
    168 hours after first dose (corresponding to 108 hours after last dose)
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: ng/mL
        geometric mean (confidence interval 90%)
    353 (250 to 498)
    480 (265 to 870)
    No statistical analyses for this end point

    Secondary: Lumefantrine Cmax after last dose

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    End point title
    		 Lumefantrine Cmax after last dose
    End point description
    Lumefantrine Cmax represents the highest concentration among four sampling time points after last dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on lumefantrine plasma concentrations. Dosing times were 0, 8, 24, 36, 48 and 60 hours.
    End point type
    Secondary
    End point timeframe
    62, 66, 68 and 84 hours after first dose (corresponding to 2, 6, 8 and 24 hours after last dose)
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: ng/mL
        geometric mean (confidence interval 90%)
    3180 (2530 to 4000)
    3510 (1880 to 6540)
    No statistical analyses for this end point

    Secondary: DHA Cmax after first dose

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    End point title
    		 DHA Cmax after first dose
    End point description
    Dihydroartemisinin (DHA) is an active metabolite of artemether. DHA Cmax represents the highest concentration between the concentrations at 1 hour and 2 hours after first dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on DHA plasma concentrations.
    End point type
    Secondary
    End point timeframe
    1 and 2 hours after first dose (Day 1)
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    20
    5
    Units: ng/mL
        geometric mean (confidence interval 90%)
    11.5 (7.58 to 17.4)
    15.7 (8.53 to 28.9)
    No statistical analyses for this end point

    Secondary: Parasite Clearance Time (PCT)

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    End point title
    		 Parasite Clearance Time (PCT)
    End point description
    PCT 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. PCT is based on uncorrected parasite counts. Patients who received rescue medication before parasite clearance were censored at the first use of rescue medication. Patients without parasite clearance were censored at the time of last parasite assessment. PCT was calculated using the Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    Up to 48 hours after first dose
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: hours
        median (inter-quartile range (Q1-Q3))
    35.0 (24.0 to 35.8)
    30.6 (23.8 to 47.6)
    No statistical analyses for this end point

    Secondary: PCR-corrected Adequate Clinical and Parasitological Response (ACPR) – PPS analysis

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    End point title
    		 PCR-corrected Adequate Clinical and Parasitological Response (ACPR) – PPS analysis
    End point description
    PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Days 15, 29 and 43. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR.
    End point type
    Secondary
    End point timeframe
    Days 15, 29 and 43
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    17
    6
    Units: percentage of participants
    number (confidence interval 95%)
        Day 15 (n=17, 6)
    100 (80.49 to 100)
    100 (54.07 to 100)
        Day 29 (n=17, 6)
    100 (80.49 to 100)
    100 (54.07 to 100)
        Day 43 (n=17, 6)
    94.1 (71.31 to 99.85)
    100 (54.07 to 100)
    No statistical analyses for this end point

    Secondary: Fever clearance Times (FCT)

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    End point title
    		 Fever clearance Times (FCT)
    End point description
    FCT 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. Patients who received rescue medication before fever clearance were censored at the first use of rescue medication. Patients without fever clearance were censored at the time of last parasite assessment. FCT was calculated using the Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    Up to 36 hours after first dose
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    4
    1
    Units: hours
        median (inter-quartile range (Q1-Q3))
    15.7 (3.9 to 29.7)
    7.6 (7.6 to 7.6)
    No statistical analyses for this end point

    Secondary: PCR-corrected Adequate Clinical and Parasitological Response (ACPR) – FAS analysis

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    End point title
    		 PCR-corrected Adequate Clinical and Parasitological Response (ACPR) – FAS analysis
    End point description
    PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Days 15, 29 and 43. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR.
    End point type
    Secondary
    End point timeframe
    Days 15, 29 and 43
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: percentage of participants
    number (confidence interval 95%)
        Day 15 (n=22, 6)
    100 (84.56 to 100)
    100 (54.07 to 100)
        Day 29 (n=22, 6)
    95.5 (77.16 to 99.88)
    100 (54.07 to 100)
        Day 43 (n=22, 6)
    90.9 (70.84 to 98.88)
    100 (54.07 to 100)
    No statistical analyses for this end point

    Secondary: PCR-uncorrected Adequate Clinical and Parasitological Response (ACPR)

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    End point title
    		 PCR-uncorrected Adequate Clinical and Parasitological Response (ACPR)
    End point description
    PCR-uncorrected ACPR, defined as the absence of parasitemia, was evaluated on Days 8, 15, 29 and 43. A participant was considered as PCR-uncorrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 8, 15, 29 or 43 irrespective of axillary temperature.
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29 and 43
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: percentage of participants
    number (confidence interval 95%)
        Day 8 (n=22, 6)
    100 (84.56 to 100)
    100 (54.07 to 100)
        Day 15 (n=22, 6)
    100 (84.56 to 100)
    100 (54.07 to 100)
        Day 29 (n=22, 6)
    77.3 (54.63 to 92.18)
    100 (54.07 to 100)
        Day 43 (n=22, 6)
    63.6 (40.66 to 82.80)
    100 (54.07 to 100)
    No statistical analyses for this end point

    Secondary: Number of participants with recrudescence events

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    End point title
    		 Number of participants with recrudescence events
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Days 15, 29 and 43
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: participants
        Day 15 (n=22, 6)
    0
    0
        Day 29 (n=22, 6)
    1
    0
        Day 43 (n=22, 6)
    1
    0
    No statistical analyses for this end point

    Secondary: Number of participants with Serious Adverse Events (SAEs)

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    End point title
    		 Number of participants with Serious Adverse Events (SAEs)
    End point description
    Number of participants with serious adverse events (SAEs), including changes in laboratory results qualifying and reported as serious adverse events.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment until 12 months of age (assessed up to maximum 1 year)
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with new infections events

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    End point title
    		 Number of participants with new infections events
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Days 15, 29 and 43
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: participants
        Day 15 (n=22, 6)
    0
    0
        Day 29 (n=22, 6)
    4
    0
        Day 43 (n=22, 6)
    2
    0
    No statistical analyses for this end point

    Secondary: Number of participants with Adverse Events (AEs)

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    End point title
    		 Number of participants with Adverse Events (AEs)
    End point description
    Number of participants with adverse events (any AEs regardless of seriousness), including changes in laboratory results qualifying and reported as adverse events.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment until Day 43
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    6
    Units: participants
    17
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events were collected from first dose of study treatment until Day 43. Deaths and serious adverse events were collected from first dose of study treatment until 1 year of age (assessed up to maximum 1 year).
    Adverse event reporting additional description
    Adverse events are assessed in the Safety Set, including all patients who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Infants >28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days

    Reporting group title
    Pooled Cohort
    Reporting group description
    		 All infants and neonates who received at least one dose of artemether-lumefantrine

    Reporting group title
    Cohort 2
    Reporting group description
    		 Term neonates 1-28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days

    Serious adverse events
    		 Cohort 1 Pooled Cohort Cohort 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 Pooled Cohort Cohort 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 22 (77.27%)
    21 / 28 (75.00%)
    4 / 6 (66.67%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 22 (31.82%)
    8 / 28 (28.57%)
    1 / 6 (16.67%)
         occurrences all number
    7
    8
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    8 / 22 (36.36%)
    10 / 28 (35.71%)
    2 / 6 (33.33%)
         occurrences all number
    13
    15
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Vomiting
         subjects affected / exposed
    6 / 22 (27.27%)
    7 / 28 (25.00%)
    1 / 6 (16.67%)
         occurrences all number
    7
    8
    1
    Infections and infestations
    Bacterial rhinitis
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    2
    2
    0
    Ear infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Gastrointestinal fungal infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Malaria
         subjects affected / exposed
    9 / 22 (40.91%)
    9 / 28 (32.14%)
    0 / 6 (0.00%)
         occurrences all number
    9
    9
    0
    Rhinitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2023
    To enable additional optional pharmacokinetics (PK) checks for artemether and lumefantrine and additional interim assessments by the data monitoring committee (DMC). In addition, text related to public health emergencies and safety reporting was updated.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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