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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2012-002432-93
    Trial protocol
    CZ   HU   ES   PL   BG   SK  
    Global end of trial date
    19 Dec 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Jul 2016
    First version publication date
    27 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN8828-4004
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01751152
    WHO universal trial number (UTN)
    U1111-1130-8441
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    26 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the effect on disease activity of a single intravenous (i.v.) dose of NNC0114-0006 with placebo in subjects with moderately to severely active Crohn’s disease.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice and FDA 21 CFR 312.50 and 56.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    14 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Czech Republic: 13
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    Serbia: 10
    Country: Number of subjects enrolled
    United States: 4
    Country: Number of subjects enrolled
    Poland: 9
    Worldwide total number of subjects
    53
    EEA total number of subjects
    27
    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)
    52
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Of the 32 sites in 8 countries that screened subjects, 24 sites in 7 countries randomised subjects to treatment as follows: Bulgaria: 2 sites; Czech Republic: 4 sites; Poland: 5 sites; Serbia: 4 sites; Russia: 4 sites; Slovakia: 2 sites; United States: 3 sites.

    Pre-assignment
    Screening details
    Not applicable

    Period 1
    Period 1 title
    Double-Blind Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    A qualified unblinded person, not involved in the conduct of the trial, was appointed to take care of all steps in trial drug handling from receipt to destruction, and only administration of the infusion was performed by blinded site staff otherwise involved in the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Double-Blind: Placebo
    Arm description
    Subjects received a single dose of placebo (for NNC0114-0006) and followed up for 24 weeks. If considered relevant and safe by the investigator at week 12 and the subject accepted, an open-label dose of NNC0114-0006 (25 mg/kg) was administered. If subjects received an open-label administration of the NNC0114-0006 at week 12, these subjects were additionally followed at weeks 13 and 36.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo was administered as an i.v. infusion over a period of 30 minutes. The total dose was calculated based on the body weight.

    Arm title
    Double-Blind: NNC0114-0006 25 mg/kg
    Arm description
    Subjects received a single dose of NNC0114-0006 and followed up for 24 weeks. If considered relevant and safe by the investigator at week 12 and the subject accepted, one additional open-label dose of NNC0114-0006 was administered at the same dose level. If subjects received an open-label administration of the NNC0114-0006 at week 12, these subjects were additionally followed at weeks 13 and 36.
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0114-0006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    NNC0114-0006 was administered as an i.v. infusion over a period of 30 minutes. The total dose was calculated based on the body weight.

    Number of subjects in period 1
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg
    Started
    17
    36
    Completed Week 12
    15
    31
    Completed
    14
    29
    Not completed
    3
    7
         Sponsor closure of trial
    1
    5
         Adverse event, non-fatal
    1
    1
         Unclassified
    1
    1
    Period 2
    Period 2 title
    Open-Label Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Open-Label: Placebo-NNC0114-0006 25 mg/kg
    Arm description
    Subjects, who received a single dose of placebo (for NNC0114-0006) in double-blind period and accepted an open-label dose of NNC0114-0006, were administered a single dose of NNC0114-0006 at Week 12. Subjects were additionally followed at weeks 13 and 36.
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0114-0006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    NNC0114-0006 was administered as an i.v. infusion over a period of 30 minutes. The total dose was calculated based on the body weight.

    Arm title
    Open-Label: NNC0114-0006 25 mg/kg-NNC0114-0006 25 mg/kg
    Arm description
    Subjects, who received a single dose of NNC0114-0006 in double-blind period and accepted for an additional open-label dose of NNC0114-0006, were administered a single dose of NNC0114-0006 at Week 12. Subjects were additionally followed at weeks 13 and 36.
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0114-0006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    NNC0114-0006 was administered as an i.v. infusion over a period of 30 minutes. The total dose was calculated based on the body weight.

    Number of subjects in period 2
    Open-Label: Placebo-NNC0114-0006 25 mg/kg Open-Label: NNC0114-0006 25 mg/kg-NNC0114-0006 25 mg/kg
    Started
    15
    28
    Completed
    11
    22
    Not completed
    4
    6
         Protocol deviation
    1
    1
         Sponsor closure of trial
    3
    4
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-Blind: Placebo
    Reporting group description
    Subjects received a single dose of placebo (for NNC0114-0006) and followed up for 24 weeks. If considered relevant and safe by the investigator at week 12 and the subject accepted, an open-label dose of NNC0114-0006 (25 mg/kg) was administered. If subjects received an open-label administration of the NNC0114-0006 at week 12, these subjects were additionally followed at weeks 13 and 36.

    Reporting group title
    Double-Blind: NNC0114-0006 25 mg/kg
    Reporting group description
    Subjects received a single dose of NNC0114-0006 and followed up for 24 weeks. If considered relevant and safe by the investigator at week 12 and the subject accepted, one additional open-label dose of NNC0114-0006 was administered at the same dose level. If subjects received an open-label administration of the NNC0114-0006 at week 12, these subjects were additionally followed at weeks 13 and 36.

    Reporting group values
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg Total
    Number of subjects
    17 36 53
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.4 ± 10.9 32 ± 13.2 -
    Gender categorical
    Units: Subjects
        Female
    5 17 22
        Male
    12 19 31
    Crohn’s Disease Activity Index
    Number of subjects analysed in NNC0114-0006 25 mg/kg group = 35.
    Units: score on a scale
        arithmetic mean (standard deviation)
    316.4 ± 45.8 309.5 ± 58.1 -
    Inflammatory bowel disease questionnaire (IBDQ) score
    Units: score on a scale
        arithmetic mean (standard deviation)
    123.8 ± 29.3 124.9 ± 31.9 -
    Short Form Health Survey (SF-36v2) physical component scores
    Units: score on a scale
        arithmetic mean (standard deviation)
    38.7 ± 4.7 38.2 ± 7.3 -
    SF-36v2 mental component scores
    Units: score on a scale
        arithmetic mean (standard deviation)
    35.6 ± 11.1 36.1 ± 10.4 -

    End points

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    End points reporting groups
    Reporting group title
    Double-Blind: Placebo
    Reporting group description
    Subjects received a single dose of placebo (for NNC0114-0006) and followed up for 24 weeks. If considered relevant and safe by the investigator at week 12 and the subject accepted, an open-label dose of NNC0114-0006 (25 mg/kg) was administered. If subjects received an open-label administration of the NNC0114-0006 at week 12, these subjects were additionally followed at weeks 13 and 36.

    Reporting group title
    Double-Blind: NNC0114-0006 25 mg/kg
    Reporting group description
    Subjects received a single dose of NNC0114-0006 and followed up for 24 weeks. If considered relevant and safe by the investigator at week 12 and the subject accepted, one additional open-label dose of NNC0114-0006 was administered at the same dose level. If subjects received an open-label administration of the NNC0114-0006 at week 12, these subjects were additionally followed at weeks 13 and 36.
    Reporting group title
    Open-Label: Placebo-NNC0114-0006 25 mg/kg
    Reporting group description
    Subjects, who received a single dose of placebo (for NNC0114-0006) in double-blind period and accepted an open-label dose of NNC0114-0006, were administered a single dose of NNC0114-0006 at Week 12. Subjects were additionally followed at weeks 13 and 36.

    Reporting group title
    Open-Label: NNC0114-0006 25 mg/kg-NNC0114-0006 25 mg/kg
    Reporting group description
    Subjects, who received a single dose of NNC0114-0006 in double-blind period and accepted for an additional open-label dose of NNC0114-0006, were administered a single dose of NNC0114-0006 at Week 12. Subjects were additionally followed at weeks 13 and 36.

    Subject analysis set title
    Open-label: Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received a single dose of placebo in double-blind period and did not accept an additional dose of NNC0114-0006. Subjects were followed up for 24 weeks.

    Subject analysis set title
    Open-label: NNC0114-0006 25 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received a single dose of NNC0114-0006 in double-blind period and did not accept an additional dose of NNC0114-0006. Subjects were followed up for 24 weeks.

    Primary: Change in Crohn’s Disease Activity Index (CDAI)

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    End point title
    Change in Crohn’s Disease Activity Index (CDAI)
    End point description
    Change from baseline in CDAI at week 4. The CDAI is a composite disease specific score consisting of 8 factors: number of liquid or very soft stool, abdominal pain, general wellbeing, complications of Crohn's disease, use of antidiarrheals, abdominal mass, hematocrit and body weight. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
    End point type
    Primary
    End point timeframe
    From baseline to Week 4
    End point values
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg
    Number of subjects analysed
    15 [1]
    33 [2]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -112 ± 83
    -125 ± 70
    Notes
    [1] - Subjects with available data for CDAI at Week 0 and Week 4.
    [2] - Subjects with available data for CDAI at Week 0 and Week 4.
    Statistical analysis title
    NNC0114-0006 25 mg/kg vs Placebo
    Statistical analysis description
    Analysis was performed using an analysis of variance (ANOVA) model on the last value before rescue/week 4. The model included treatment, prior failure to biological therapy (Yes/No), CDAI (below 330, 330 or more) and the interaction between the two strata as fixed factors and baseline CDAI as continuous covariate. Number of subjects in this analysis was 52 (35 subjects in NNC0114-0006 25 mg/kg group and 17 in placebo group). Due to EUDRACT error, on adding the 2 groups, N is shown 48.
    Comparison groups
    Double-Blind: Placebo v Double-Blind: NNC0114-0006 25 mg/kg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3812
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -20
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -67
         upper limit
    26

    Secondary: Change in CDAI

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    End point title
    Change in CDAI
    End point description
    Change from baseline in CDAI at week 12. The CDAI is a composite disease specific score consisting of 8 factors: number of liquid or very soft stool, abdominal pain, general wellbeing, complications of Crohn's disease, use of antidiarrheals, abdominal mass, hematocrit and body weight. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12
    End point values
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg
    Number of subjects analysed
    14 [3]
    27 [4]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -111 ± 104
    -156 ± 83
    Notes
    [3] - Subjects with available data for CDAI at Week 0 and Week 12.
    [4] - Subjects with available data for CDAI at Week 0 and Week 12.
    No statistical analyses for this end point

    Secondary: Clinical Remission, Defined as CDAI of Less Than 150

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    End point title
    Clinical Remission, Defined as CDAI of Less Than 150
    End point description
    The CDAI is a composite disease specific score consisting of 8 factors: number of liquid or very soft stool, abdominal pain, general wellbeing, complications of Crohn's disease, use of antidiarrheals, abdominal mass, hematocrit and body weight. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Percentage of subjects with clinical remission at week 8 are reported.
    End point type
    Secondary
    End point timeframe
    At week 8
    End point values
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg
    Number of subjects analysed
    14 [5]
    32 [6]
    Units: percentage of subjects
        number (not applicable)
    28.6
    37.5
    Notes
    [5] - Subjects with available data for CDAI at week 0 and week 8.
    [6] - Subjects with available data for CDAI at week 0 and week 8.
    No statistical analyses for this end point

    Secondary: Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score

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    End point title
    Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
    End point description
    The IBDQ is a health related quality of life questionnaire specific to IBDs. IBDQ include 32 items covering four domains with a recall period of two weeks. The four domains covered are bowel symptoms, systemic systems, social function, and emotional health. Each item is scored from 1 to 7 and the overall score for the IBDQ is the sum of responses to each of the items. The overall score range from 32 to 224 with higher scores indicating better health related quality of life.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4
    End point values
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg
    Number of subjects analysed
    16 [7]
    35 [8]
    Units: score on scale
        arithmetic mean (standard deviation)
    22.5 ± 19.3
    33.7 ± 26.3
    Notes
    [7] - Subjects with available data for IBDQ at week 0 and week 4.
    [8] - Subjects with available data for IBDQ at week 0 and week 4.
    No statistical analyses for this end point

    Secondary: Changes in the Short Form Health Survey (SF-36v2) Physical and Mental Component Scores

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    End point title
    Changes in the Short Form Health Survey (SF-36v2) Physical and Mental Component Scores
    End point description
    Change from baseline in SF-36v2 physical and mental component scores at week 4. The SF-36v2 is a health survey which assesses the functional status and well-being of the patient utilising 36 questions designed to measure 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Physical and mental health scores represent overall physical and mental health. Each domain is scored on 100-point scale with higher scores indicating a better health state.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4
    End point values
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg
    Number of subjects analysed
    16 [9]
    35 [10]
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Change in Physical Component Score
    3.2 ± 5.5
    6 ± 5.5
        Change in Mental Component Score
    5.5 ± 10.1
    7 ± 8.4
    Notes
    [9] - Subjects with available data for SF-36v2 at week 0 and week 4.
    [10] - Subjects with available data for SF-36v2 at week 0 and week 4.
    No statistical analyses for this end point

    Secondary: Incidence of Adverse Events (AEs)

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    End point title
    Incidence of Adverse Events (AEs)
    End point description
    An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). A serious AE (SAE) is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or occurrence of congenital anomaly.
    End point type
    Secondary
    End point timeframe
    Up to weeks 24 or 36
    End point values
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg Open-Label: Placebo-NNC0114-0006 25 mg/kg Open-Label: NNC0114-0006 25 mg/kg-NNC0114-0006 25 mg/kg Open-label: Placebo Open-label: NNC0114-0006 25 mg/kg
    Number of subjects analysed
    17 [11]
    36 [12]
    15 [13]
    28 [14]
    2 [15]
    8 [16]
    Units: events
        All AEs
    15
    45
    5
    37
    0
    1
        SAEs
    0
    1
    1
    7
    0
    0
    Notes
    [11] - Safety analysis set: All randomized and exposed subjects.
    [12] - Safety analysis set: All randomized and exposed subjects.
    [13] - Safety analysis set: All randomized and exposed subjects.
    [14] - Safety analysis set: All randomized and exposed subjects.
    [15] - Safety analysis set: All randomized and exposed subjects.
    [16] - Safety analysis set: All randomized and exposed subjects.
    No statistical analyses for this end point

    Secondary: Incidence of Anti-NNC0114-0006 Antibodies

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    End point title
    Incidence of Anti-NNC0114-0006 Antibodies
    End point description
    Percentage of subjects with antibodies against NNC01140006.
    End point type
    Secondary
    End point timeframe
    Up to weeks 24 or 36
    End point values
    Double-Blind: Placebo Double-Blind: NNC0114-0006 25 mg/kg
    Number of subjects analysed
    17 [17]
    36 [18]
    Units: percentage of patients
        number (not applicable)
    0
    0
    Notes
    [17] - Safety analysis set: All randomized and exposed subjects.
    [18] - Safety analysis set: All randomized and exposed subjects.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 or 36 weeks
    Adverse event reporting additional description
    Analysis was performed on the safety analysis set.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Double-blind: Placebo
    Reporting group description
    Subjects received a single dose of placebo (for NNC0114-0006) and followed up for 24 weeks. If considered relevant and safe by the investigator at week 12 and the subject accepted, an open-label dose of NNC0114-0006 was administered. If subjects received an open-label administration of the NNC0114-0006 at week 12, these subjects were additionally followed at weeks 13 and 36.

    Reporting group title
    Double-blind: NNC0114-0006 25 mg/kg
    Reporting group description
    Subjects received a single dose of NNC0114-0006 and followed up for 24 weeks. If considered relevant and safe by the investigator at week 12 and the subject accepted, one additional open-label dose of NNC0114-0006 was administered at the same dose level. If subjects received an open-label administration of the NNC0114-0006 at week 12, these subjects were additionally followed at weeks 13 and 36.

    Reporting group title
    Open-label: Placebo
    Reporting group description
    Subjects received a single dose of placebo in double-blind period and did not accept an additional dose of NNC0114-0006. Subjects were followed up for 24 weeks.

    Reporting group title
    Open-label: Placebo-NNC0114-0006 25 mg/kg
    Reporting group description
    Subjects, who received a single dose of placebo (for NNC0114-0006) in double-blind period and accepted an open-label dose of NNC0114-0006, were administered a single dose of NNC0114-0006 at week 12. Subjects were additionally followed at weeks 13 and 36.

    Reporting group title
    Open-label: NNC0114-0006 25 mg/kg
    Reporting group description
    Subjects received a single dose of NNC0114-0006 in double-blind period and did not accept an additional dose of NNC0114-0006. Subjects were followed up for 24 weeks.

    Reporting group title
    Open-label: NNC0114-0006 25 mg/kg-NNC0114-0006 25 mg/kg
    Reporting group description
    Subjects, who received a single dose of NNC0114-0006 in double-blind period and accepted for an additional open-label dose of NNC0114-0006, were administered a single dose of NNC0114-0006 at week 12. Subjects were additionally followed at weeks 13 and 36.

    Serious adverse events
    Double-blind: Placebo Double-blind: NNC0114-0006 25 mg/kg Open-label: Placebo Open-label: Placebo-NNC0114-0006 25 mg/kg Open-label: NNC0114-0006 25 mg/kg Open-label: NNC0114-0006 25 mg/kg-NNC0114-0006 25 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 36 (2.78%)
    0 / 2 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    4 / 28 (14.29%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal neoplasm
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 36 (2.78%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    3 / 28 (10.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine inflammation
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Double-blind: Placebo Double-blind: NNC0114-0006 25 mg/kg Open-label: Placebo Open-label: Placebo-NNC0114-0006 25 mg/kg Open-label: NNC0114-0006 25 mg/kg Open-label: NNC0114-0006 25 mg/kg-NNC0114-0006 25 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 17 (35.29%)
    10 / 36 (27.78%)
    0 / 2 (0.00%)
    4 / 15 (26.67%)
    1 / 8 (12.50%)
    9 / 28 (32.14%)
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 36 (2.78%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Aspartate aminotransferase abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood lactate dehydrogenase abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood uric acid abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gamma-glutamyltransferase abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Lipase abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 36 (5.56%)
    0 / 2 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    5
    0
    1
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 36 (5.56%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    2
    0
    0
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 36 (8.33%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    4
    0
    0
    0
    3
    Anal fistula
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Crohn's disease
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 36 (5.56%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 36 (2.78%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    1
    0
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Seborrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 36 (2.78%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    Fistula discharge
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 36 (0.00%)
    0 / 2 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 36 (8.33%)
    0 / 2 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 36 (2.78%)
    0 / 2 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Sep 2013
    1) Exclusion criterion amended as recombinant immunoblot assay agent no longer available for the anti-HCV antibody confirmatory test. 2) Text regarding re-screening was modified to include repeat of endoscopy within 8 weeks of the initial screening.
    10 Oct 2014
    1) Extension of timelines. 2) Change of two inclusion criteria.

    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.
    Because of the small trial population, the planned statistical analyses did not have the intended power and the results should be interpreted with caution.
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