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    Clinical Trial Results:
    Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

    Summary
    EudraCT number
    		 2012-004098-26
    Trial protocol
    		 DE   CZ   HU   IT   ES   FR  
    Global end of trial date
    14 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2018
    First version publication date
    07 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5170C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune
    Sponsor organisation address
    Milstein Building, Granta Park, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Robert A Gasser, MedImmune, 1 3013982450, gasserr@medimmune.com
    Scientific contact
    Robert A Gasser, MedImmune, 1 3013982450, gasserr@medimmune.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
    14 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of MEDI2070 versus placebo to induce a clinical effect (defined as at least a 100-point reduction in Crohn's Disease Activity Index [CDAI] from baseline) or remission at Week 8 in subjects with moderate to severe Crohn’s Disease.
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and was consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements, and any conditions required by a regulatory authority and/or Institutional Review Board/ Independent Ethics Committee that approved this study. Subjects signed an informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2013
    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
    United States: 31
    Country: Number of subjects enrolled
    Canada: 24
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Poland: 6
    Worldwide total number of subjects
    121
    EEA total number of subjects
    66
    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)
    121
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 174 subjects were screened between 01Feb2013 and 26Feb2014 across 9 countries (USA, Canada, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain).

    Pre-assignment
    Screening details
    		 Out of 174 screened subjects, 53 were considered screen failures. A total of 121 subjects were randomized, of which 2 did not receive study drugs and 119 were treated in the study.

    Period 1
    Period 1 title
    Double-Blind Induction Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received IV Placebo at Week 0 and Week 4.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo (matching to MEDI2070 700 mg) was administered by intravenous (IV) infusion at Week 0 (Day 1) and Week 4 in double-blind period. Placebo was delivered in 5.0% weight/volume (w/v) dextrose in a volume of 100 mL over a minimum of 60 minutes using an infusion pump.

    Arm title
    		 MEDI2070 700mg
    Arm description
    		 Subject received IV MEDI2070 700mg at Week 0 and Week 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI2070
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    MEDI2070 700mg was administered by IV infusion at Week 0 (Day 1) and Week 4 in double-blind period. MEDI2070 was delivered in 5.0% w/v dextrose in a volume of 100 mL over a minimum of 60 minutes using an infusion pump.

    Number of subjects in period 1 [1]
    		Placebo MEDI2070 700mg
    Started
    60
    59
    Completed
    52
    52
    Not completed
    8
    7
         Consent withdrawn by subject
    5
    3
         Adverse event, non-fatal
    -
    1
         Subject not entered in open label period
    3
    1
         Lost to follow-up
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Total subjects enrolled worldwide were 121; of which 2 subjects were randomized but not treated. Those 2 subject were not included in mITT population and data for those 2 subjects were not captured for baseline characteristics.
    Period 2
    Period 2 title
    Open-Label Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/MEDI2070 210mg
    Arm description
    		 Subjects randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 every 4 weeks (Q4W) during the 100-week, open-label treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI2070
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MEDI2070 210 mg was administered by subcutaneous (SC) injection every 4 weeks (Q4W) between Week 12 and Week 112 in open-label period.

    Arm title
    		 MEDI2070 700mg/MEDI2070 210mg
    Arm description
    		 Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 Q4W during the 100-week, open-label treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI2070
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MEDI2070 210 mg was administered by SC injection every 4 weeks (Q4W) between Week 12 and Week 112 in open-label period.

    Number of subjects in period 2
    		Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
    Started
    52
    52
    Completed
    33
    24
    Not completed
    19
    28
         Consent withdrawn by subject
    9
    19
         Adverse event, non-fatal
    1
    -
         Not specified
    1
    3
         Lost to follow-up
    3
    4
         Development of study-specific withdrawal criteria
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received IV Placebo at Week 0 and Week 4.

    Reporting group title
    MEDI2070 700mg
    Reporting group description
    		 Subject received IV MEDI2070 700mg at Week 0 and Week 4.

    Reporting group values
    		 Placebo MEDI2070 700mg Total
    Number of subjects
    		 60 59 119
    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)
    		 60 59 119
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.1 ± 10.7 34.8 ± 11.1 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 37 37 74
        Male
    		 23 22 45
    CDAI score
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    		 312.4 ± 56.3 325.0 ± 59.2 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received IV Placebo at Week 0 and Week 4.

    Reporting group title
    MEDI2070 700mg
    Reporting group description
    		 Subject received IV MEDI2070 700mg at Week 0 and Week 4.
    Reporting group title
    Placebo/MEDI2070 210mg
    Reporting group description
    		 Subjects randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 every 4 weeks (Q4W) during the 100-week, open-label treatment period.

    Reporting group title
    MEDI2070 700mg/MEDI2070 210mg
    Reporting group description
    		 Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 Q4W during the 100-week, open-label treatment period.

    Primary: Percentage of Subjects With Crohn's Disease Activity Index (CDAI) Response at Week 8

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    End point title
    		 Percentage of Subjects With Crohn's Disease Activity Index (CDAI) Response at Week 8
    End point description
    A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (<) 150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT) population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Percentage of subjects
        number (not applicable)
    26.7
    49.2
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v MEDI2070 700mg
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk Difference
    Point estimate
    22.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 8.3
         upper limit
    		 36.8

    Secondary: Percentage of Subjects With CDAI Remission at Week 8

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    End point title
    		 Percentage of Subjects With CDAI Remission at Week 8
    End point description
    The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of < 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Percentage of subjects
        number (not applicable)
    15
    27.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With CDAI-100 Point Improvement at Week 8

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    End point title
    		 Percentage of Subjects With CDAI-100 Point Improvement at Week 8
    End point description
    The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Percentage of subjects
        number (not applicable)
    25
    45.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With CDAI-70 Point Improvement at Week 8

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    End point title
    		 Percentage of Subjects With CDAI-70 Point Improvement at Week 8
    End point description
    The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Percentage of subjects
        number (not applicable)
    46.7
    52.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With CDAI Response at Week 12

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    End point title
    		 Percentage of Subjects With CDAI Response at Week 12
    End point description
    The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Percentage of subjects
        number (not applicable)
    28.3
    37.3
    No statistical analyses for this end point

    Secondary: Change from Baseline in CDAI Total Score at Week 8

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    End point title
    		 Change from Baseline in CDAI Total Score at Week 8
    End point description
    The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    57
    52
    Units: Scores on a scale
        least squares mean (standard error)
    -62.7 ± 13.5
    -99.0 ± 15.0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period
    End point description
    An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.
    End point type
    Secondary
    End point timeframe
    From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Subjects
        Any TEAEs
    41
    40
        Any TESAEs
    5
    5
    No statistical analyses for this end point

    Secondary: Number of Subjects With TEAEs and TESAEs in Open-label Period

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    End point title
    		 Number of Subjects With TEAEs and TESAEs in Open-label Period
    End point description
    An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.
    End point type
    Secondary
    End point timeframe
    From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
    End point values
    		 Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
    Number of subjects analysed
    52
    52
    Units: Subjects
        Any TEAEs
    44
    43
        Any TESAEs
    8
    12
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinical Laboratory Abnormalities Reported as TEAEs in Double-blind Period

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    End point title
    		 Number of Subjects with Clinical Laboratory Abnormalities Reported as TEAEs in Double-blind Period
    End point description
    The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Subjects
        Anaemia
    2
    1
        Leukopenia
    0
    1
        Neutropenia
    0
    1
        Urine analysis abnormal
    1
    0
        Urine abnormality
    0
    1
        Urine bilirubin increased
    0
    1
        Proteinuria
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period

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    End point title
    		 Number of Subjects with Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period
    End point description
    The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.
    End point type
    Secondary
    End point timeframe
    From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
    End point values
    		 Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
    Number of subjects analysed
    52
    52
    Units: Subjects
        Anaemia
    5
    5
        Lymphocyte count decreased
    0
    1
        Lymphopenia
    0
    1
        Neutrophil count increased
    0
    1
        Platelet count increased
    0
    1
        Red cell distribution width increased
    0
    1
        White blood cell count decreased
    0
    1
        Chromaturia
    0
    1
        Blood uric acid increased
    1
    0
        Hypokalaemia
    1
    1
        Hepatic enzyme increased
    0
    1
        Hyperlipidemia
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period

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    End point title
    		 Number of Subjects With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period
    End point description
    The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). Subjects in the safety population were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vital Signs Abnormalities Reported as TEAEs in Open-label Period

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    End point title
    		 Number of Subjects With Vital Signs Abnormalities Reported as TEAEs in Open-label Period
    End point description
    The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.
    End point type
    Secondary
    End point timeframe
    From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
    End point values
    		 Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
    Number of subjects analysed
    52
    52
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Maximum Mean Serum Concentration of MEDI2070 in Double-blind Period

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    End point title
    		 Maximum Mean Serum Concentration of MEDI2070 in Double-blind Period
    End point description
    Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (99999). Here, 'n' denotes number of subjects analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: mcg/mL
    arithmetic mean (standard deviation)
        Week 0 Post-dose (n= 60, 58)
    99999 ± 99999
    186 ± 83.8
        Week 4 Pre-dose (n= 54, 53)
    99999 ± 99999
    37.4 ± 52.3
        Week 4 Post-dose (n= 52, 51)
    99999 ± 99999
    209 ± 68.9
        Week 8 Post-dose (n= 55, 51)
    99999 ± 99999
    39.2 ± 18.4
    No statistical analyses for this end point

    Secondary: Maximum Mean Serum Concentration of MEDI2070 in Open-label Period

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    End point title
    		 Maximum Mean Serum Concentration of MEDI2070 in Open-label Period
    End point description
    The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (99999). Here, 'n' denotes number of subjects analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Weeks 12, 24, and 112
    End point values
    		 Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
    Number of subjects analysed
    52
    52
    Units: mcg/mL
    arithmetic mean (standard deviation)
        Week 12 Pre-dose (51, 52)
    99999 ± 99999
    16.7 ± 11.8
        Week 24 Pre-dose (n= 48, 43)
    14.5 ± 7.0
    15.1 ± 6.38
        Week 112 Pre-dose (n= 24, 20)
    18.3 ± 7.73
    22.4 ± 7.97
    No statistical analyses for this end point

    Secondary: Number of Subjects With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period

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    End point title
    		 Number of Subjects With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period
    End point description
    The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week0/Day 1) up to 28 week post last dose (approximately 36 weeks)
    End point values
    		 Placebo MEDI2070 700mg
    Number of subjects analysed
    60
    59
    Units: Subjects
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With ADA Positive to MEDI2070 in Open-label Period

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    End point title
    		 Number of Subjects With ADA Positive to MEDI2070 in Open-label Period
    End point description
    The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 28 week post last dose (approximately 140 weeks)
    End point values
    		 Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
    Number of subjects analysed
    52
    52
    Units: Subjects
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study drug administration (Day 1) to 36 weeks post last dose (approximately 148 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received IV Placebo at Week 0 and Week 4.

    Reporting group title
    MEDI2070 700mg
    Reporting group description
    		 Subjects received IV MEDI2070 700mg at Week 0 and Week 4.

    Reporting group title
    Placebo/MEDI2070 210mg
    Reporting group description
    		 Subjects who completed the placebo treatment in double-blind period were entered in open-label period to receive SC MEDI2070 210mg Q4W starting from Week 12 to Week 112.‌

    Reporting group title
    MEDI2070 700mg/MEDI2070 210mg
    Reporting group description
    		 Subjects who completed IV MEDI2070 700 mg treatment in double-blind period were entered in open-label period to receive SC MEDI2070 210mg Q4W starting from Week 12 to Week 112.

    Serious adverse events
    		 Placebo MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 60 (8.33%)
    5 / 59 (8.47%)
    8 / 52 (15.38%)
    12 / 52 (23.08%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Intestinal anastomosis complication
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental exposure to product
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Shock
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 59 (3.39%)
    1 / 52 (1.92%)
    6 / 52 (11.54%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 60 (63.33%)
    38 / 59 (64.41%)
    43 / 52 (82.69%)
    42 / 52 (80.77%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 59 (5.08%)
    1 / 52 (1.92%)
    3 / 52 (5.77%)
         occurrences all number
    0
    4
    1
    3
    Headache
         subjects affected / exposed
    4 / 60 (6.67%)
    10 / 59 (16.95%)
    12 / 52 (23.08%)
    11 / 52 (21.15%)
         occurrences all number
    5
    11
    62
    28
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 59 (1.69%)
    5 / 52 (9.62%)
    3 / 52 (5.77%)
         occurrences all number
    4
    2
    7
    3
    Asthenia
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 59 (3.39%)
    1 / 52 (1.92%)
    5 / 52 (9.62%)
         occurrences all number
    1
    2
    1
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 59 (1.69%)
    5 / 52 (9.62%)
    4 / 52 (7.69%)
         occurrences all number
    1
    1
    6
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 60 (10.00%)
    6 / 59 (10.17%)
    9 / 52 (17.31%)
    10 / 52 (19.23%)
         occurrences all number
    10
    7
    15
    14
    Crohn's disease
         subjects affected / exposed
    3 / 60 (5.00%)
    3 / 59 (5.08%)
    6 / 52 (11.54%)
    7 / 52 (13.46%)
         occurrences all number
    3
    3
    6
    9
    Diarrhoea
         subjects affected / exposed
    4 / 60 (6.67%)
    0 / 59 (0.00%)
    7 / 52 (13.46%)
    7 / 52 (13.46%)
         occurrences all number
    4
    0
    7
    9
    Nausea
         subjects affected / exposed
    3 / 60 (5.00%)
    3 / 59 (5.08%)
    5 / 52 (9.62%)
    6 / 52 (11.54%)
         occurrences all number
    3
    5
    5
    9
    Vomiting
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 59 (5.08%)
    8 / 52 (15.38%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    55
    3
    Constipation
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 59 (3.39%)
    0 / 52 (0.00%)
    5 / 52 (9.62%)
         occurrences all number
    2
    2
    0
    7
    Toothache
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 59 (3.39%)
    4 / 52 (7.69%)
    1 / 52 (1.92%)
         occurrences all number
    1
    2
    4
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 59 (5.08%)
    5 / 52 (9.62%)
    5 / 52 (9.62%)
         occurrences all number
    2
    3
    7
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 60 (10.00%)
    9 / 59 (15.25%)
    8 / 52 (15.38%)
    15 / 52 (28.85%)
         occurrences all number
    6
    9
    12
    31
    Sinusitis
         subjects affected / exposed
    4 / 60 (6.67%)
    0 / 59 (0.00%)
    3 / 52 (5.77%)
    1 / 52 (1.92%)
         occurrences all number
    5
    0
    6
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 59 (3.39%)
    5 / 52 (9.62%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    5
    2
    Gastroenteritis viral
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 59 (1.69%)
    2 / 52 (3.85%)
    2 / 52 (3.85%)
         occurrences all number
    2
    1
    2
    2
    Influenza
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    8 / 52 (15.38%)
    5 / 52 (9.62%)
         occurrences all number
    1
    0
    10
    5
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 59 (1.69%)
    8 / 52 (15.38%)
    1 / 52 (1.92%)
         occurrences all number
    1
    1
    8
    2
    Bronchitis
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 59 (1.69%)
    5 / 52 (9.62%)
    2 / 52 (3.85%)
         occurrences all number
    1
    1
    5
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    4 / 52 (7.69%)
    4 / 52 (7.69%)
         occurrences all number
    1
    0
    5
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2012
    • Exclusion Criterion revised to include eye disorders (not including refraction errors), neurological disorders, myocardial infarction or acute coronary syndrome within 12 months prior to screening • Three items added to the list of reasons for discontinuation of study drug: recurrence of significant Crohn’s disease symptoms, according to investigator judgment, subject develops a malignant neoplasm, and mycobacterial infections, systemic fungal infections, or viral infections requiring hospitalization or parenteral antiviral therapy . • For subjects permanently discontinued from study drug, instruction was added that investigators were to refer subjects for appropriate medical care in coordination with subject’s personal physician • Requirement added that subjects be followed for at least 6 hours after IV administration of first dose of study drug and, if no adverse reaction, 2 hours after administration of second dose

    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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