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    Clinical Trial Results:
    An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

    Summary
    EudraCT number
    2015-001834-15
    Trial protocol
    ES   BE   NL   DE  
    Global end of trial date
    19 Jun 2019

    Results information
    Results version number
    v1
    This version publication date
    28 May 2020
    First version publication date
    28 May 2020
    Other versions
    v2

    Trial information

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    Trial identification
    Sponsor protocol code
    1311.20
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, Binger Strasse 173
    Public contact
    Boehringer Ingelheim, Boehringer Ingelheim, Call Center, 001 18002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.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 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to investigate long-term safety of risankizumab (BI 655066/ABBV-066) in participants with moderately to severely active Crohn's disease who showed a clinical response or remission on previous treatment with risankizumab in Study NCT02031276 (BI trial 1311.6/ AbbVie M15-993) and were now receiving long-term treatment. Additional objectives of this study were to further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of risankizumab.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all subjects as required.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Sep 2015
    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
    Canada: 1
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    65
    EEA total number of subjects
    52
    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)
    63
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This trial was an open label, single group, long term safety extension trial of Risankizumab, in patients with moderately to severely active Crohn's Disease.

    Pre-assignment
    Screening details
    All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were no to be entered in the trial if any of the entry criteria were violated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This trial was an open label trial.

    Arms
    Arm title
    All Risankizumab
    Arm description
    Participants who received at least one dose of risankizumab in the current study
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab 600 mg IV
    Investigational medicinal product code
    Other name
    BI 655066 / ABBV-066
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants with clinical response or remission at the end of Study NCT02031276 (Boehringer Ingelheim trial 1311.6/ AbbVie M15-993) or at screening for this study were rolled over directly into this study and received maintenance therapy of risankizumab 180 mg administered subcutaneously (SC) every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who lost response or remission between the completion of Study NCT02031276 and enrollment in this study received open-label intravenous (IV) re-induction treatment with risankizumab consisting of 3 infusions of 600 mg (10 mg/ml) IV every 4 weeks (q4w), after which eligibility was assessed if clinical response was re-gained. If clinical response or remission was achieved, participants continued with maintenance treatment of risankizumab 180 mg SC q8w beginning at Visit 5.

    Investigational medicinal product name
    Risankizumab 180 mg SC
    Investigational medicinal product code
    Other name
    BI 655066 / ABBV-066
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants with clinical response or remission at the end of Study NCT02031276 (Boehringer Ingelheim trial 1311.6/ AbbVie M15-993) or at screening for this study were rolled over directly into this study and received maintenance therapy of risankizumab 180 mg (90 mg/ml) administered subcutaneously (SC) every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who lost response or remission between the completion of Study NCT02031276 and enrollment in this study received open-label intravenous (IV) re-induction treatment with risankizumab consisting of 3 infusions of 600 mg (10 mg/ml) IV every 4 weeks (q4w), after which eligibility was assessed if clinical response was re-gained. If clinical response or remission was achieved, participants continued with maintenance treatment of risankizumab 180 mg SC q8w beginning at Visit 5.

    Number of subjects in period 1
    All Risankizumab
    Started
    65
    Completed
    44
    Not completed
    21
         Lack of response
    1
         Adverse event, non-fatal
    7
         Subject decision
    2
         Surgery planned-- not done
    1
         Loss of efficacy
    2
         Pregnancy
    2
         Reproductive plans
    1
         Withdrew consent
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Risankizumab
    Reporting group description
    Participants who received at least one dose of risankizumab in the current study

    Reporting group values
    All Risankizumab Total
    Number of subjects
    65 65
    Age categorical
    Analysis Population: All participants who received at least one dose of risankizumab in the current study
    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)
    63 63
        From 65-84 years
    2 2
        85 years and over
    0 0
    Age Continuous
    Analysis Population: All participants who received at least one dose of risankizumab in the current study
    Units: years
        arithmetic mean (standard deviation)
    37.1 ( 12.97 ) -
    Sex: Female, Male
    Analysis Population: All participants who received at least one dose of risankizumab in the current study
    Units:
        Female
    36 36
        Male
    29 29
    Race (NIH/OMB)
    Analysis Population: All participants who received at least one dose of risankizumab in the current study
    Units: Subjects
        American Indian or Alaska Native
    0 0
        Asian
    10 10
        Native Hawaiian or Other Pacific Islander
    0 0
        Black or African American
    0 0
        White
    55 55
        More than one race
    0 0
        Unknown or Not Reported
    0 0
    Baseline Corticosteroid Use
    Analysis Population: All participants who received at least one dose of risankizumab in the current study
    Units: Subjects
        Yes
    21 21
        No.
    44 44
        Missing
    0 0
    Tumor Necrosis Factor (TNF) Antagonist Exposure
    Analysis Population: All participants who received at least one dose of risankizumab in the current study
    Units: Subjects
        Anti-TNF Experienced
    60 60
        Anti-TNF Naive
    5 5
        Missing
    0 0
    Crohn’s Disease Activity Index (CDAI)
    The Crohn's Disease Activity Index (CDAI) is a composite score that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. Items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Analysis Population: All participants who received at least one dose of risankizumab in the current study
    Units: units on a scale
        arithmetic mean (standard deviation)
    304.771 ( 77.9832 ) -
    High-sensitivity C-Reactive Protein (hs-CRP)
    Analysis Population: All participants who received at least one dose of risankizumab in the current study
    Units: mg/L
        arithmetic mean (standard deviation)
    20.315 ( 23.1676 ) -

    End points

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    End points reporting groups
    Reporting group title
    All Risankizumab
    Reporting group description
    Participants who received at least one dose of risankizumab in the current study

    Subject analysis set title
    Risankizumab 600 mg IV
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained

    Subject analysis set title
    Risankizumab 180 mg SC
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.

    Primary: Number of Participants with Adverse Events

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    End point title
    Number of Participants with Adverse Events [1]
    End point description
    A treatment emergent adverse event was defined as an event that occurred or worsened on or after the first dose of study drug through 140 days after the last dose in the current study for participants not rolling over into M16-000 Sub-study 3 or until the first dose of study drug in NCT03105102. All treatment-emergent serious and nonserious adverse events were collected, whether elicited or spontaneously reported by the participant. Analysis Population: All participants who received at least one dose of risankizumab in the current study
    End point type
    Primary
    End point timeframe
    From the time of study drug administration until 140 days after the last dose of study drug in the current study or until the first dose of study drug in NCT03105102 (AbbVie M16-000 Sub-study 3), up to 4 years for participants who rolled-over
    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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.
    End point values
    All Risankizumab Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    65
    4
    65
    Units: Participants
    60
    2
    60
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit

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    End point title
    Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit
    End point description
    The Crohn's Disease Activity Index (CDAI) is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score < 150. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study. 9999 stands for 'not available'.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
    End point values
    Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    4
    65
    Units: percentage of participants
    number (not applicable)
        Week 0
    25.00
    72.31
        Week 4
    25.00
    9999
        Week 8
    25.00
    73.85
        Week 16
    9999
    71.88
        Week 24
    9999
    74.60
        Week 32
    9999
    78.69
        Week 40
    9999
    81.67
        Week 48
    9999
    79.31
        Week 56
    9999
    80.70
        Week 64
    9999
    87.27
        Week 72
    9999
    83.33
        Week 80
    9999
    79.25
        Week 88
    9999
    78.43
        Week 96
    9999
    84.62
        Week 104
    9999
    85.71
        Week 112
    9999
    87.50
        Week 120
    9999
    83.33
        Week 128
    9999
    86.96
        Week 136
    9999
    76.92
        Week 144
    9999
    78.38
        Week 152
    9999
    76.67
        Week 160
    9999
    78.26
        Week 168
    9999
    70.59
        Week 176
    9999
    60.00
        Week 184
    9999
    40.00
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit

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    End point title
    Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit
    End point description
    CDAI is a composite instrument that includes participant symptoms evaluated over 7 days, as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical response is defined as CDAI score < 150 or a reduction from baseline of at least 100 points. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276. OC analysis was performed on the ITT analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study. 9999 stands for 'not available'.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
    End point values
    Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    4
    65
    Units: percentage of participants
    number (not applicable)
        Week 0
    50.00
    90.77
        Week 4
    75.00
    9999
        Week 8
    100.00
    98.46
        Week 16
    9999
    92.19
        Week 24
    9999
    95.24
        Week 32
    9999
    95.08
        Week 40
    9999
    96.67
        Week 48
    9999
    94.83
        Week 56
    9999
    92.98
        Week 64
    9999
    96.36
        Week 72
    9999
    94.44
        Week 80
    9999
    92.45
        Week 88
    9999
    92.16
        Week 96
    9999
    92.31
        Week 104
    9999
    93.88
        Week 112
    9999
    93.75
        Week 120
    9999
    93.75
        Week 128
    9999
    93.48
        Week 136
    9999
    92.31
        Week 144
    9999
    91.89
        Week 152
    9999
    93.33
        Week 160
    9999
    91.30
        Week 168
    9999
    82.35
        Week 176
    9999
    80.00
        Week 184
    9999
    80.00
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit

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    End point title
    Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit
    End point description
    The PRO-2 is calculated based on the sum of the weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in the 7 days prior to the study visit. The PRO-2 score is calculated by adding the values of the summed stool frequency scores multiplied by 2 plus the summed abdominal pain scores multiplied by 5. The SF and AP score at an assessment visit was the average of the daily values reported during the 7 days preceding the scheduled assessment visit. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. Remission is defined as PRO-2 score < 75. OC analysis was performed on the ITT analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study. 9999 stands for 'not available'.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
    End point values
    Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    4
    65
    Units: percentage of participants
    number (not applicable)
        Week 0
    25.00
    73.85
        Week 4
    25.00
    9999
        Week 8
    50.00
    80.00
        Week 16
    9999
    78.13
        Week 24
    9999
    77.78
        Week 32
    9999
    85.25
        Week 40
    9999
    83.33
        Week 48
    9999
    82.76
        Week 56
    9999
    87.72
        Week 64
    9999
    81.82
        Week 72
    9999
    81.48
        Week 80
    9999
    81.13
        Week 88
    9999
    82.35
        Week 96
    9999
    84.62
        Week 104
    9999
    85.71
        Week 112
    9999
    91.67
        Week 120
    9999
    85.42
        Week 128
    9999
    89.13
        Week 136
    9999
    87.50
        Week 144
    9999
    86.49
        Week 152
    9999
    86.67
        Week 160
    9999
    73.91
        Week 168
    9999
    77.78
        Week 176
    9999
    60.00
        Week 184
    9999
    40.00
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit

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    End point title
    Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit
    End point description
    PRO-2 is calculated based on the sum of the weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in last 7 days. PRO-2 score is calculated by adding values of summed stool frequency scores multiplied by 2 plus summed abdominal pain scores multiplied by 5. SF and AP score was the average of the daily values reported during last 7 days. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. PRO-2 response is defined as a decrease from baseline of 50 points or more. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276. analysis performed ITT analysis sets. ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study. 9999 stands for 'not available'.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
    End point values
    Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    4
    65
    Units: percentage of participants
    number (not applicable)
        Week 0
    50.00
    83.08
        Week 4
    50.00
    9999
        Week 8
    50.00
    86.15
        Week 16
    9999
    90.63
        Week 24
    9999
    92.06
        Week 32
    9999
    86.89
        Week 40
    9999
    98.33
        Week 48
    9999
    93.10
        Week 56
    9999
    91.23
        Week 64
    9999
    90.91
        Week 72
    9999
    88.89
        Week 80
    9999
    88.68
        Week 88
    9999
    86.27
        Week 96
    9999
    88.46
        Week 104
    9999
    87.76
        Week 112
    9999
    87.50
        Week 120
    9999
    91.67
        Week 128
    9999
    91.30
        Week 136
    9999
    92.50
        Week 144
    9999
    89.19
        Week 152
    9999
    93.33
        Week 160
    9999
    86.96
        Week 168
    9999
    83.33
        Week 176
    9999
    100.00
        Week 184
    9999
    100.00
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit

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    End point title
    Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit
    End point description
    CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Remission is defined as a score of 4 or less, by visit (or for participants with initial isolated ileitis a score of 2 or less). Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 48, 104, 152, and 200
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    63
    Units: percentage of participants
    number (not applicable)
        Week 0
    42.86
        Week 48
    56.45
        Week 104
    62.79
        Week 152
    58.97
        Week 200
    85.71
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit

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    End point title
    Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit
    End point description
    CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Response is defined as a score of 7 or less (or for participants with initial isolated ileitis > 50% reduction from baseline). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 48, 104, 152, and 200
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    63
    Units: percentage of participants
    number (not applicable)
        Week 0
    58.73
        Week 48
    72.58
        Week 104
    81.40
        Week 152
    82.05
        Week 200
    100.00
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Mucosal Healing by Visit

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    End point title
    Percentage of Participants with Mucosal Healing by Visit
    End point description
    Mucosal healing is defined as Crohn's Disease Endoscopy Index of Severity (CDEIS) ulcerations sub-score (deep ulceration, superficial ulceration, ulcerated stenosis) of 0 as evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The overall CDEIS score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 48, 104, 152, and 200
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    64
    Units: percentage of participants
    number (not applicable)
        Week 0
    29.69
        Week 48
    35.48
        Week 104
    39.53
        Week 152
    43.59
        Week 200
    42.86
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Deep Remission by Visit

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    End point title
    Percentage of Participants Achieving Deep Remission by Visit
    End point description
    Deep remission is defined as clinical remission (CDAI < 150) and CDEIS remission (CDEIS score of 4 or less, by visit or for participants with initial isolated ileitis a score of 2 or less). Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 48, 104, 152, and 200
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    63
    Units: percentage of participants
    number (not applicable)
        Week 0
    34.92
        Week 48
    47.54
        Week 104
    53.49
        Week 152
    42.86
        Week 200
    0.00
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit

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    End point title
    Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit
    End point description
    The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). IBDQ remission is defined as IBDQ total score > 170 points. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: percentage of participants
    number (not applicable)
        Week 0
    62.50
        Week 24
    58.46
        Week 48
    70.00
        Week 72
    69.23
        Week 96
    72.55
        Week 120
    70.83
        Week 144
    65.00
        Week 168
    69.57
        Week 192
    66.67
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit

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    End point title
    Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit
    End point description
    IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). IBDQ response is defined as increase in IBDQ total score >16 points from baseline. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). OC analysis was performed on the ITT SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: percentage of participants
    number (not applicable)
        Week 0
    92.19
        Week 24
    89.23
        Week 48
    95.00
        Week 72
    88.46
        Week 96
    90.20
        Week 120
    95.83
        Week 144
    92.50
        Week 168
    86.96
        Week 192
    100.00
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit

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    End point title
    Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit
    End point description
    CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276. A negative change from baseline indicates improvement. OC analysis was performed on the ITT analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study. 9999 stands for 'not available'.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
    End point values
    Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    4
    65
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    -50.70 ( 84.565 )
    -198.47 ( 101.762 )
        Week 4
    -92.68 ( 40.688 )
    9999 ( 9999 )
        Week 8
    -119.40 ( 32.967 )
    -206.75 ( 83.580 )
        Week 16
    9999 ( 9999 )
    -205.93 ( 92.837 )
        Week 24
    9999 ( 9999 )
    -194.34 ( 82.840 )
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit

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    End point title
    Mean Change from Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit
    End point description
    PRO-2 is calculated based on the sum of weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in last 7 days. The PRO-2 score is calculated by adding values of summed stool frequency scores multiplied by 2 plus summed abdominal pain scores multiplied by 5. The SF and AP score at a visit was the average of the daily values reported during the last 7 days. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. Baseline is the last measurement prior to first dose of the study drug in the feeder study NCT02031276. A negative change from baseline indicates improvement. OC analysis was performed on ITT analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study. 9999 stands for 'not available'.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
    End point values
    Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    4
    65
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    -27.75 ( 48.979 )
    -105.46 ( 58.807 )
        Week 4
    -35.25 ( 27.011 )
    9999 ( 9999 )
        Week 8
    -53.75 ( 24.405 )
    -109.53 ( 49.419 )
        Week 16
    9999 ( 9999 )
    -108.32 ( 52.848 )
        Week 24
    9999 ( 9999 )
    -105.40 ( 50.167 )
        Week 32
    9999 ( 9999 )
    -109.41 ( 56.459 )
        Week 40
    9999 ( 9999 )
    -116.33 ( 43.511 )
        Week 48
    9999 ( 9999 )
    -111.29 ( 48.048 )
        Week 56
    9999 ( 9999 )
    -115.54 ( 51.279 )
        Week 64
    9999 ( 9999 )
    -113.02 ( 57.338 )
        Week 72
    9999 ( 9999 )
    -112.11 ( 56.819 )
        Week 80
    9999 ( 9999 )
    -106.42 ( 58.710 )
        Week 88
    9999 ( 9999 )
    -108.67 ( 51.214 )
        Week 96
    9999 ( 9999 )
    -109.81 ( 50.927 )
        Week 104
    9999 ( 9999 )
    -109.10 ( 49.562 )
        Week 112
    9999 ( 9999 )
    -109.75 ( 52.951 )
        Week 120
    9999 ( 9999 )
    -111.10 ( 47.360 )
        Week 128
    9999 ( 9999 )
    -113.02 ( 50.738 )
        Week 136
    9999 ( 9999 )
    -113.00 ( 51.575 )
        Week 144
    9999 ( 9999 )
    -115.35 ( 53.460 )
        Week 152
    9999 ( 9999 )
    -109.17 ( 56.659 )
        Week 160
    9999 ( 9999 )
    -96.70 ( 54.018 )
        Week 168
    9999 ( 9999 )
    -111.09 ( 55.287 )
        Week 176
    9999 ( 9999 )
    -103.06 ( 42.717 )
        Week 184
    9999 ( 9999 )
    -129.13 ( 70.484 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit

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    End point title
    Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit
    End point description
    CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 48, 104, 152, and 200
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    63
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    -8.08 ( 5.973 )
        Week 48
    -9.32 ( 6.014 )
        Week 104
    -9.24 ( 6.035 )
        Week 152
    -9.75 ( 7.254 )
        Week 200
    -10.76 ( 5.209 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit

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    End point title
    Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit
    End point description
    SES-CD is calculated based the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 48, 104, 152, and 200
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    63
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    -9.63 ( 8.001 )
        Week 48
    -12.35 ( 7.753 )
        Week 104
    -11.56 ( 8.060 )
        Week 152
    -12.63 ( 9.139 )
        Week 200
    -13.36 ( 7.521 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Stool Frequency (SF) By Visit

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    End point title
    Mean Change From Baseline in Stool Frequency (SF) By Visit
    End point description
    Participants were asked to record the frequency of liquid stools on a daily basis. The number of liquid stools in the prior 7 days was summed. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study. 9999 stands for 'not available'.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
    End point values
    Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    4
    65
    Units: number of liquid stools in prior 7 days
    arithmetic mean (standard deviation)
        Week 0
    -0.46 ( 2.319 )
    -4.13 ( 3.273 )
        Week 4
    -0.46 ( 1.584 )
    9999 ( 9999 )
        Week 8
    -1.07 ( 1.421 )
    -4.22 ( 3.160 )
        Week 16
    9999 ( 9999 )
    -4.10 ( 3.223 )
        Week 24
    9999 ( 9999 )
    -4.19 ( 3.209 )
        Week 32
    9999 ( 9999 )
    -4.08 ( 3.536 )
        Week 40
    9999 ( 9999 )
    -4.58 ( 3.037 )
        Week 48
    9999 ( 9999 )
    -4.31 ( 3.278 )
        Week 56
    9999 ( 9999 )
    -4.48 ( 3.282 )
        Week 64
    9999 ( 9999 )
    -4.41 ( 3.514 )
        Week 72
    9999 ( 9999 )
    -4.25 ( 3.513 )
        Week 80
    9999 ( 9999 )
    -4.00 ( 3.469 )
        Week 88
    9999 ( 9999 )
    -4.04 ( 3.331 )
        Week 96
    9999 ( 9999 )
    -4.27 ( 3.037 )
        Week 104
    9999 ( 9999 )
    -4.00 ( 2.943 )
        Week 112
    9999 ( 9999 )
    -3.91 ( 2.951 )
        Week 120
    9999 ( 9999 )
    -3.99 ( 2.840 )
        Week 128
    9999 ( 9999 )
    -4.05 ( 3.060 )
        Week 136
    9999 ( 9999 )
    -3.95 ( 3.137 )
        Week 144
    9999 ( 9999 )
    -4.13 ( 3.308 )
        Week 152
    9999 ( 9999 )
    -4.00 ( 3.150 )
        Week 160
    9999 ( 9999 )
    -3.71 ( 3.044 )
        Week 168
    9999 ( 9999 )
    -4.08 ( 3.353 )
        Week 176
    9999 ( 9999 )
    -3.61 ( 2.583 )
        Week 184
    9999 ( 9999 )
    -4.50 ( 3.881 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Abdominal Pain (AP) Score By Visit

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    End point title
    Mean Change From Baseline in Abdominal Pain (AP) Score By Visit
    End point description
    Participants were asked to rate and record daily abdominal pain on a scale of 0 to 3 [none (0), mild (1), moderate (2) and severe (3)]. The ratings in the prior 7 days were summed. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study. 9999 stands for 'not applicable'.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
    End point values
    Risankizumab 600 mg IV Risankizumab 180 mg SC
    Number of subjects analysed
    4
    65
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    -0.61 ( 1.006 )
    -1.36 ( 0.885 )
        Week 4
    -0.82 ( 0.768 )
    9999 ( 9999 )
        Week 8
    -1.11 ( 0.357 )
    -1.44 ( 0.746 )
        Week 16
    9999 ( 9999 )
    -1.45 ( 0.773 )
        Week 24
    9999 ( 9999 )
    -1.33 ( 0.804 )
        Week 32
    9999 ( 9999 )
    -1.49 ( 0.760 )
        Week 40
    9999 ( 9999 )
    -1.49 ( 0.766 )
        Week 48
    9999 ( 9999 )
    -1.46 ( 0.720 )
        Week 56
    9999 ( 9999 )
    -1.51 ( 0.815 )
        Week 64
    9999 ( 9999 )
    -1.47 ( 0.825 )
        Week 72
    9999 ( 9999 )
    -1.50 ( 0.839 )
        Week 80
    9999 ( 9999 )
    -1.44 ( 0.816 )
        Week 88
    9999 ( 9999 )
    -1.49 ( 0.787 )
        Week 96
    9999 ( 9999 )
    -1.43 ( 0.881 )
        Week 104
    9999 ( 9999 )
    -1.52 ( 0.861 )
        Week 112
    9999 ( 9999 )
    -1.57 ( 0.890 )
        Week 120
    9999 ( 9999 )
    -1.58 ( 0.735 )
        Week 128
    9999 ( 9999 )
    -1.61 ( 0.776 )
        Week 136
    9999 ( 9999 )
    -1.65 ( 0.792 )
        Week 144
    9999 ( 9999 )
    -1.64 ( 0.836 )
        Week 152
    9999 ( 9999 )
    -1.52 ( 0.833 )
        Week 160
    9999 ( 9999 )
    -1.28 ( 0.788 )
        Week 168
    9999 ( 9999 )
    -1.54 ( 0.657 )
        Week 176
    9999 ( 9999 )
    -1.50 ( 0.670 )
        Week 184
    9999 ( 9999 )
    -1.89 ( 0.921 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit

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    End point title
    Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit
    End point description
    IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline. OC analysis was performed on the intent-to-treat ITT SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    62.48 ( 38.791 )
        Week 24
    58.72 ( 35.626 )
        Week 48
    64.03 ( 33.039 )
        Week 72
    64.14 ( 42.229 )
        Week 96
    62.38 ( 39.220 )
        Week 120
    67.28 ( 34.390 )
        Week 144
    61.34 ( 34.894 )
        Week 168
    56.36 ( 33.035 )
        Week 192
    71.17 ( 41.911 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit

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    End point title
    Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit
    End point description
    IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline. OC analysis was performed on the ITT SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    20.44 ( 11.680 )
        Week 24
    18.26 ( 11.587 )
        Week 48
    20.29 ( 10.861 )
        Week 72
    20.64 ( 12.547 )
        Week 96
    19.12 ( 13.064 )
        Week 120
    22.25 ( 10.473 )
        Week 144
    20.46 ( 10.639 )
        Week 168
    18.44 ( 10.658 )
        Week 192
    22.67 ( 14.962 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit

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    End point title
    Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit
    End point description
    IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline. OC analysis was performed on the ITT SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    9.9 ( 6.66 )
        Week 24
    9.1 ( 6.44 )
        Week 48
    9.6 ( 6.08 )
        Week 72
    10.1 ( 7.36 )
        Week 96
    10.3 ( 5.80 )
        Week 120
    9.8 ( 6.16 )
        Week 144
    8.9 ( 6.02 )
        Week 168
    8.2 ( 5.10 )
        Week 192
    11.8 ( 4.62 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit

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    End point title
    Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit
    End point description
    IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline. OC analysis was performed on the ITT SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    11.04 ( 8.230 )
        Week 24
    10.57 ( 7.652 )
        Week 48
    11.64 ( 7.487 )
        Week 72
    11.20 ( 8.731 )
        Week 96
    10.59 ( 8.556 )
        Week 120
    11.92 ( 7.347 )
        Week 144
    10.93 ( 8.309 )
        Week 168
    10.87 ( 9.503 )
        Week 192
    11.67 ( 9.266 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit

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    End point title
    Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit
    End point description
    IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline. OC analysis was performed on the ITT SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 0
    21.09 ( 16.820 )
        Week 24
    20.79 ( 15.632 )
        Week 48
    22.55 ( 14.965 )
        Week 72
    22.23 ( 17.912 )
        Week 96
    22.41 ( 17.075 )
        Week 120
    23.35 ( 15.391 )
        Week 144
    21.03 ( 15.044 )
        Week 168
    18.87 ( 14.552 )
        Week 192
    25.00 ( 21.373 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in High-Sensitivity C-reactive Protein (hs-CRP) by Visit

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    End point title
    Mean Change From Baseline in High-Sensitivity C-reactive Protein (hs-CRP) by Visit
    End point description
    Concentration of serum high-sensitivity C-reactive Protein (hs-CRP) was analyzed by a central laboratory. It is a general marker of inflammation that is sensitive to acute changes in inflammatory response, and higher levels indicate more inflammation. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: milligrams per liter (mg/L)
    arithmetic mean (standard deviation)
        Week 0
    -14.64 ( 22.842 )
        Week 8
    -15.84 ( 22.548 )
        Week 24
    -12.76 ( 24.457 )
        Week 40
    -14.32 ( 24.080 )
        Week 56
    -16.11 ( 24.194 )
        Week 72
    -14.40 ( 21.878 )
        Week 88
    -17.07 ( 23.312 )
        Week 104
    -14.44 ( 20.057 )
        Week 120
    -13.81 ( 22.667 )
        Week 128
    -14.87 ( 20.133 )
        Week 136
    -15.78 ( 20.864 )
        Week 152
    -17.03 ( 20.998 )
        Week 160
    -18.43 ( 22.147 )
        Week 176
    -20.49 ( 25.062 )
        Week 184
    -25.01 ( 32.459 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit

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    End point title
    Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit
    End point description
    Fecal calprotectin (FCP) is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Stool samples were analyzed by a central laboratory for fecal calprotectin levels. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline. Analysis Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 24, 56, 88, 120, 152, and 184
    End point values
    Risankizumab 180 mg SC
    Number of subjects analysed
    65
    Units: microgram per gram (μg/g)
    arithmetic mean (standard deviation)
        Week 0
    -1983.9 ( 3402.12 )
        Week 24
    -2166.4 ( 4035.66 )
        Week 56
    -2277.8 ( 4104.19 )
        Week 88
    -2485.9 ( 4157.37 )
        Week 120
    -2031.9 ( 5187.92 )
        Week 152
    -2631.5 ( 4589.62 )
        Week 184
    -4436.1 ( 7455.55 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    TEAEs and TESAEs were collected from the first dose of study drug until 140 days after the last dose of study drug in the current study or until the first dose of study drug in NCT03105102, up to 4 years for participants who rolled-over.
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 140 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Risankizumab 600 mg IV
    Reporting group description
    Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained.

    Reporting group title
    Risankizumab 180 mg SC
    Reporting group description
    Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.

    Reporting group title
    All Risankizumab
    Reporting group description
    Participants who received at least one dose of risankizumab in the current study.

    Serious adverse events
    Risankizumab 600 mg IV Risankizumab 180 mg SC All Risankizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    23 / 65 (35.38%)
    23 / 65 (35.38%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Anastomotic leak
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 65 (3.08%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Selective abortion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid sinus syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cluster headache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 65 (3.08%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dumping syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileal stenosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal stenosis
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 65 (3.08%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 65 (3.08%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 65 (3.08%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 65 (1.54%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Risankizumab 600 mg IV Risankizumab 180 mg SC All Risankizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    52 / 65 (80.00%)
    52 / 65 (80.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    4
    4
    Weight increased
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 65 (3.08%)
    2 / 65 (3.08%)
         occurrences all number
    1
    2
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    0
    5
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    9 / 65 (13.85%)
    9 / 65 (13.85%)
         occurrences all number
    0
    15
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 4 (0.00%)
    13 / 65 (20.00%)
    13 / 65 (20.00%)
         occurrences all number
    0
    14
    14
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 65 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    1
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    5
    5
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    12 / 65 (18.46%)
    12 / 65 (18.46%)
         occurrences all number
    0
    13
    13
    Abdominal pain upper
         subjects affected / exposed
    1 / 4 (25.00%)
    4 / 65 (6.15%)
    5 / 65 (7.69%)
         occurrences all number
    1
    6
    7
    Constipation
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    4
    4
    Crohn's disease
         subjects affected / exposed
    0 / 4 (0.00%)
    10 / 65 (15.38%)
    10 / 65 (15.38%)
         occurrences all number
    0
    11
    11
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    8 / 65 (12.31%)
    8 / 65 (12.31%)
         occurrences all number
    0
    9
    9
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    4
    4
    Haematochezia
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 65 (3.08%)
    2 / 65 (3.08%)
         occurrences all number
    1
    5
    6
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    10 / 65 (15.38%)
    10 / 65 (15.38%)
         occurrences all number
    0
    10
    10
    Odynophagia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 65 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    1
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 4 (25.00%)
    4 / 65 (6.15%)
    5 / 65 (7.69%)
         occurrences all number
    1
    4
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 65 (9.23%)
    6 / 65 (9.23%)
         occurrences all number
    0
    10
    10
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    0
    5
    5
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    4
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    0
    5
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    11 / 65 (16.92%)
    11 / 65 (16.92%)
         occurrences all number
    0
    14
    14
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    8 / 65 (12.31%)
    8 / 65 (12.31%)
         occurrences all number
    0
    10
    10
    Myalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    0
    6
    6
    Pain in extremity
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    0
    8
    8
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    4
    4
    Gastroenteritis
         subjects affected / exposed
    0 / 4 (0.00%)
    15 / 65 (23.08%)
    15 / 65 (23.08%)
         occurrences all number
    0
    19
    19
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    8 / 65 (12.31%)
    8 / 65 (12.31%)
         occurrences all number
    0
    11
    11
    Nasopharyngitis
         subjects affected / exposed
    1 / 4 (25.00%)
    20 / 65 (30.77%)
    20 / 65 (30.77%)
         occurrences all number
    2
    38
    40
    Oral herpes
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    0
    6
    6
    Pharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    7
    7
    Rhinitis
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 65 (9.23%)
    6 / 65 (9.23%)
         occurrences all number
    0
    7
    7
    Sinusitis
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    0
    6
    6
    Tooth abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    0
    7
    7
    Tracheitis
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    5
    5
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    7 / 65 (10.77%)
    7 / 65 (10.77%)
         occurrences all number
    1
    8
    9
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    9 / 65 (13.85%)
    9 / 65 (13.85%)
         occurrences all number
    0
    10
    10
    Metabolism and nutrition disorders
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 65 (3.08%)
    3 / 65 (4.62%)
         occurrences all number
    1
    2
    3
    Vitamin D deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 65 (6.15%)
    4 / 65 (6.15%)
         occurrences all number
    0
    4
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2015
    Amendment 1: Substantive changes from the original protocol to Amendment 1 were to clarify entry criteria for subjects rolling over from Study M15-993 who have lost a previous response/remission, change pregnancy test at screening to be a blood test only if urine test was positive, remove CRP and fecal calprotectin as measured biomarkers, replace numeric rating scale for abdominal pain with categorical pain scale of none, mild, moderate and severe, clarify definitions of SAE and AE relatedness, add possibility of interim analyses as deemed necessary by the Sponsor, administrative changes, and other changes throughout the protocol to accommodate the major design changes.
    13 Oct 2016
    Amendment 2: Substantive changes from Amendment 1 to Amendment 2 were to change study sponsorship from Boehringer Ingelheim (BI) only to BI outside the United States and AbbVie in the United States.
    28 Apr 2017
    Amendment 3: Substantive changes from Amendment 2 to Amendment 3 were to change the study protocol format to the AbbVie template and add the AbbVie study number of Study M15-989, remove the checklist for drug-induced liver injury, modify description of study team structure, modify AE definition to align with AbbVie procedures, and modify description of statistical analyses.
    25 Jul 2018
    Amendment 4: Substantive changes from Amendment 3 to Amendment 4 were to terminate this study and add the option for subjects who complete the EOT visit to enroll into Study M16-000 Sub-study 3, make modifications throughout the protocol to accommodate this design change, change the follow-up period from 15 to 20 weeks after last dose of study drug, and update benefit/risk information.

    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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