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    Clinical Trial Results:
    KAND567 Versus Placebo in Subjects Hospitalized with COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics.

    Summary
    EudraCT number
    2020-002322-85
    Trial protocol
    SE   DK  
    Global end of trial date
    07 Aug 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Jul 2022
    First version publication date
    02 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KAN0006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Kancera AB
    Sponsor organisation address
    Karolinska Institutet Science Park, Nanna Svartz Väg 4, Solna, Sweden, SE-171 65
    Public contact
    Niclas Brynne, PhD, Kancera AB, +46 (0)8 50 12 60 80, niclas.brynne@kancera.com
    Scientific contact
    Niclas Brynne, PhD, Kancera AB, +46 (0)8 50 12 60 80, niclas.brynne@kancera.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the impact of oral administration of KAND567 versus placebo, in COVID-19 subjects admitted to the hospital for care of COVID-19 infection with respect to rates of adverse events (AEs) and serious adverse events (SAEs).
    Protection of trial subjects
    The external Safety Review Committee (SRC) consisted of 3 members representing appropriate clinical expertise and having extensive experience in clinical study design and conduct. No formal statistical interim analysis was to be performed, but the SRC was to evaluate all available efficacy and safety data after 10 and 20 patients had completed the 7 day treatment period. Based on this evaluation, the SRC was to give a recommendation either to continue as planned, modify the study design, or stop the study prematurely. Their recommendation was to be discussed and agreed with the Sponsor’s CMO, who was responsible for making the ultimate decision. SRC meetings consisted of an open session, based on the fully blinded dataset, to discuss general study issues. This was followed by the closed portion of the meeting, for SRC members only, to discuss the unblinded dataset (produced by an independent external programmer).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Oct 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
    Sweden: 34
    Country: Number of subjects enrolled
    Denmark: 1
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    32
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    COVID-19 patients admitted to the hospital received Best Supportive Care and could be screened for inclusion in the study. If all the criteria for study participation were fulfilled and informed consent was signed, the subject was enrolled and randomized to one of the two treatment arms.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer
    Blinding implementation details
    The placebo was identical in appearance to KAND567, and the site staff, sponsor and CRO were blinded throughout the study. The staff at Tamro (responsible for labeling) and the staff at Q&Q Labs AB (responsible for bioanalysis) were unblinded. The independent Safety Review Committee (SRC) was also unblinded during the closed portion of their meetings, which was supported by the external, unblinded programmer who produced the dataset.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    KAND567 (250 mg BID)
    Arm description
    KAND567 (250 mg) was orally administered every 12 hours (at 8am and 8pm ± 1 hour) with an initial loading dose of either 250 mg or 500 mg KAND567, depending on the time of inclusion (see below). The initial loading dose of KAND567 was given as follows: - 500 mg was given to patients when included in the study 12 to 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour) - 250 mg was given to patients when included in the study less than 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour)
    Arm type
    Experimental

    Investigational medicinal product name
    KAND567
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    KAND567 (250 mg) was orally administered every 12 hours (at 8am and 8pm ± 1 hour) with an initial loading dose of either 250 mg or 500 mg KAND567, depending on the time of inclusion (see below). The initial loading dose of KAND567 was given as follows: - 500 mg was given to patients when included in the study 12 to 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour) - 250 mg was given to patients when included in the study less than 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour)

    Arm title
    Placebo
    Arm description
    Placebo was orally administered every 12 hours (at 8am and 8pm ± 1 hour)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was orally administered every 12 hours (at 8am and 8pm ± 1 hour)

    Number of subjects in period 1
    KAND567 (250 mg BID) Placebo
    Started
    16
    19
    Completed
    12
    16
    Not completed
    4
    3
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    KAND567 (250 mg BID)
    Reporting group description
    KAND567 (250 mg) was orally administered every 12 hours (at 8am and 8pm ± 1 hour) with an initial loading dose of either 250 mg or 500 mg KAND567, depending on the time of inclusion (see below). The initial loading dose of KAND567 was given as follows: - 500 mg was given to patients when included in the study 12 to 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour) - 250 mg was given to patients when included in the study less than 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour)

    Reporting group title
    Placebo
    Reporting group description
    Placebo was orally administered every 12 hours (at 8am and 8pm ± 1 hour)

    Reporting group values
    KAND567 (250 mg BID) Placebo Total
    Number of subjects
    16 19 35
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    14 18 32
        From 65-84 years
    2 1 3
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    5 7 12
        Male
    11 12 23
    Subject analysis sets

    Subject analysis set title
    KAND567 (Safety Analysis Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Randomized subjects who received any dose of KAND567 and for whom any post-dose data were available. Subjects were to be analyzed according to the treatment they actually received.

    Subject analysis set title
    Placebo (Safety Analysis Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Randomized subjects who received any dose of placebo and for whom any post-dose data were available. Subjects were to be analyzed according to the treatment they actually received.

    Subject analysis sets values
    KAND567 (Safety Analysis Set) Placebo (Safety Analysis Set)
    Number of subjects
    15
    18
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    13
    18
        From 65-84 years
    2
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    5
    7
        Male
    10
    11

    End points

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    End points reporting groups
    Reporting group title
    KAND567 (250 mg BID)
    Reporting group description
    KAND567 (250 mg) was orally administered every 12 hours (at 8am and 8pm ± 1 hour) with an initial loading dose of either 250 mg or 500 mg KAND567, depending on the time of inclusion (see below). The initial loading dose of KAND567 was given as follows: - 500 mg was given to patients when included in the study 12 to 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour) - 250 mg was given to patients when included in the study less than 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour)

    Reporting group title
    Placebo
    Reporting group description
    Placebo was orally administered every 12 hours (at 8am and 8pm ± 1 hour)

    Subject analysis set title
    KAND567 (Safety Analysis Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Randomized subjects who received any dose of KAND567 and for whom any post-dose data were available. Subjects were to be analyzed according to the treatment they actually received.

    Subject analysis set title
    Placebo (Safety Analysis Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Randomized subjects who received any dose of placebo and for whom any post-dose data were available. Subjects were to be analyzed according to the treatment they actually received.

    Primary: Number of Adverse Events

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    End point title
    Number of Adverse Events [1]
    End point description
    End point type
    Primary
    End point timeframe
    The AE reporting period started at the first administration of IMP and ended at the last FU visit.
    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 analyses were performed for this endpoint.
    End point values
    KAND567 (Safety Analysis Set) Placebo (Safety Analysis Set)
    Number of subjects analysed
    15
    18
    Units: occurrences
    71
    70
    No statistical analyses for this end point

    Primary: Number of Serious Adverse Events

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    End point title
    Number of Serious Adverse Events [2]
    End point description
    End point type
    Primary
    End point timeframe
    The AE reporting period started at the first administration of IMP and ended at the last follow-up visit.
    Notes
    [2] - 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 analyses were performed for this endpoint.
    End point values
    KAND567 (Safety Analysis Set) Placebo (Safety Analysis Set)
    Number of subjects analysed
    15
    18
    Units: occurrences
    5
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The AE reporting period started at the first administration of IMP and ended at the last follow-up visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    KAND567
    Reporting group description
    KAND567 (250 mg) was orally administered every 12 hours (at 8am and 8pm ± 1 hour) with an initial loading dose of either 250 mg or 500 mg KAND567, depending on the time of inclusion (see below). The initial loading dose of KAND567 was given as follows: - 500 mg was given to patients when included in the study 12 to 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour) - 250 mg was given to patients when included in the study less than 6 hours prior to a scheduled dose (at 8 am or 8 pm ± 1 hour)

    Reporting group title
    Placebo
    Reporting group description
    Placebo was orally administered every 12 hours (at 8am and 8pm ± 1 hour)

    Serious adverse events
    KAND567 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 15 (33.33%)
    2 / 18 (11.11%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Investigations
    Myocardial strain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    KAND567 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    17 / 18 (94.44%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Laryngeal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Confusional state
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Mental fatigue
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Investigations
    Fibrin D dimer increased
         subjects affected / exposed
    4 / 15 (26.67%)
    5 / 18 (27.78%)
         occurrences all number
    4
    5
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    4 / 15 (26.67%)
    3 / 18 (16.67%)
         occurrences all number
    4
    3
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    3 / 18 (16.67%)
         occurrences all number
    1
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Blood alkaline phosphate increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Blood lactate dehydrogenase abnormal
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Blood pressure diastolic increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    3 / 15 (20.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    1
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Liver function test increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    PO2 decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Pulmonary arterial pressure increased
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    Serum ferritin increased
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 18 (11.11%)
         occurrences all number
    1
    2
    Transaminases increased
         subjects affected / exposed
    2 / 15 (13.33%)
    3 / 18 (16.67%)
         occurrences all number
    2
    3
    Troponin increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 18 (5.56%)
         occurrences all number
    2
    1
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    2
    Paraesthesia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Thrombocytosis
         subjects affected / exposed
    2 / 15 (13.33%)
    4 / 18 (22.22%)
         occurrences all number
    2
    4
    Anaemia
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 18 (11.11%)
         occurrences all number
    2
    2
    Leukocytosis
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 18 (11.11%)
         occurrences all number
    2
    2
    Neutrophilia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Gastroesophageal reflux disease
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Glossodynia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 18 (11.11%)
         occurrences all number
    3
    2
    Stomatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Alopecia
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 18 (11.11%)
         occurrences all number
    1
    2
    Rash
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    3 / 15 (20.00%)
    4 / 18 (22.22%)
         occurrences all number
    3
    4
    Glycosuria
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Muscle twitching
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Erythema migrans
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2020
    Sweden: Changes to inclusion/exclusion criteria, clarifications made regarding restricted medications, secondary endpoints, sampling, and treatment discontinuation, and dosing diary implemented.
    04 Mar 2021
    Denmark: Change to inclusion/exclusion criteria and the sponsor’s medical representative, clarifications made regarding timing of assessments, and dosing diary implemented.
    31 May 2021
    Sweden: Changes to inclusion/exclusion criteria and sponsor's medical representative, and clarifications made regarding timing of assessments.
    29 Jun 2021
    Sweden: Change in the primary objective and endpoint.
    19 Jul 2021
    Denmark: Change in the primary objective and endpoint.

    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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