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    Clinical Trial Results:
    A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

    Summary
    EudraCT number
    		 2017-000574-11
    Trial protocol
    		 IE   GB   DE   HU   AT   LT   CZ   NL   SK   BG   GR   PL   BE   ES   PT   EE   HR   IT   RO  
    Global end of trial date
    13 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2024
    First version publication date
    09 Jun 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SHP647-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03283085
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 Shire Way, Lexington, United States, MA 02421
    Public contact
    Study Director, Shire, N/A +1 866-8425335, ClinicalTransparency@shire.com
    Scientific contact
    Study Director, Shire, N/A +1 866-8425335, ClinicalTransparency@shire.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe UC or CD.
    Protection of trial subjects
    Each participant signed an informed consent form (ICF) before participating in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 2018
    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
    South Africa: 11
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Ukraine: 66
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 52
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 3
    Country: Number of subjects enrolled
    Bulgaria: 20
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Croatia: 11
    Country: Number of subjects enrolled
    Czechia: 15
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 24
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Italy: 22
    Country: Number of subjects enrolled
    Japan: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 16
    Country: Number of subjects enrolled
    Lebanon: 1
    Country: Number of subjects enrolled
    Lithuania: 3
    Country: Number of subjects enrolled
    Mexico: 14
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Poland: 146
    Country: Number of subjects enrolled
    Portugal: 7
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    Russian Federation: 43
    Country: Number of subjects enrolled
    Serbia: 1
    Country: Number of subjects enrolled
    Slovakia: 17
    Worldwide total number of subjects
    557
    EEA total number of subjects
    296
    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)
    11
    Adults (18-64 years)
    512
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 225 investigative sites in 33 countries from 27 February 2018 to 13 December 2023.

    Pre-assignment
    Screening details
    		 Participants from induction and maintenance studies of ulcerative colitis (UC) [SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and SHP647-303 (NCT03290781)] and Crohn’s disease (CD) [SHP647-305 (NCT03559517), SHP647-306 (NCT03566823), and SHP647-307 (NCT03627091)] were enrolled to receive either 25 milligrams (mg) or 75 mg ontamalimab.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 UC: Ontamalimab 25 mg
    Arm description
    		 Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ontamalimab 25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ontamalimab 25 mg, subcutaneously (SC), every 4 weeks (Q4W)

    Arm title
    		 UC: Ontamalimab 25mg then 75 mg
    Arm description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ontamalimab 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ontamalimab 75 mg, subcutaneously (SC), every 4 weeks (Q4W)

    Investigational medicinal product name
    Ontamalimab 25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ontamalimab 25 mg, subcutaneously (SC), every 4 weeks (Q4W)

    Arm title
    		 UC: Ontamalimab 75mg
    Arm description
    		 Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ontamalimab 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ontamalimab 75 mg, subcutaneously (SC), every 4 weeks (Q4W)

    Arm title
    		 CD: Ontamalimab 25 mg
    Arm description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ontamalimab 25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ontamalimab 25 mg, subcutaneously (SC), every 4 weeks (Q4W)

    Arm title
    		 CD: Ontamalimab 25 mg then 75 mg
    Arm description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ontamalimab 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ontamalimab 75 mg, subcutaneously (SC), every 4 weeks (Q4W)

    Investigational medicinal product name
    Ontamalimab 25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ontamalimab 25 mg, subcutaneously (SC), every 4 weeks (Q4W)

    Arm title
    		 CD: Ontamalimab 75 mg
    Arm description
    		 Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ontamalimab 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ontamalimab 75 mg, subcutaneously (SC), every 4 weeks (Q4W)

    Number of subjects in period 1
    		UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg
    Started
    89
    159
    268
    5
    10
    26
    Completed
    0
    117
    129
    0
    6
    12
    Not completed
    89
    42
    139
    5
    4
    14
         Adverse event, serious fatal
    -
    -
    3
    1
    -
    -
         Consent withdrawn by subject
    42
    21
    66
    3
    3
    5
         Physician decision
    14
    8
    19
    -
    -
    2
         Adverse event, non-fatal
    18
    3
    13
    -
    -
    5
         Pregnancy
    -
    -
    1
    -
    -
    -
         Site Terminated by Sponsor
    1
    -
    3
    -
    -
    -
         Lost to follow-up
    2
    -
    2
    -
    -
    1
         Reason not Specified
    -
    4
    8
    -
    -
    1
         Lack of efficacy
    12
    6
    24
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    UC: Ontamalimab 25 mg
    Reporting group description
    		 Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years

    Reporting group title
    UC: Ontamalimab 25mg then 75 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

    Reporting group title
    UC: Ontamalimab 75mg
    Reporting group description
    		 Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

    Reporting group title
    CD: Ontamalimab 25 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Reporting group title
    CD: Ontamalimab 25 mg then 75 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

    Reporting group title
    CD: Ontamalimab 75 mg
    Reporting group description
    		 Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

    Reporting group values
    		 UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg Total
    Number of subjects
    		 89 159 268 5 10 26
    Age Categorical
    Units: Subjects
    Gender categorical
    Units: Subjects
        Female
    		 29 67 111 1 5 14 227
        Male
    		 60 92 157 4 5 12 330
    Age categorical
    Units: Subjects
        <= 18 years
    		 0 2 7 0 1 1 11
        Between 18 and 65
    		 87 148 239 4 9 25 512
        >= 65 years
    		 2 9 22 1 0 0 34
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 12 15 0 1 2 35
        Not Hispanic or Latino
    		 84 146 251 5 9 24 519
        Unknown or Not Reported
    		 0 1 2 0 0 0 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 2 4 0 0 1 7
        Asian
    		 7 14 24 1 0 0 46
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 0 0 0 1
        Black or African American
    		 0 2 4 0 0 2 8
        White
    		 77 135 231 4 9 23 479
        More than one race
    		 2 2 3 0 0 0 7
        Unknown or Not Reported
    		 2 4 2 0 1 0 9
    Subject analysis sets

    Subject analysis set title
    UC: Ontamalimab 25mg then 75 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 3 years.

    Subject analysis set title
    UC: Ontamalimab 75mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Subject analysis set title
    CD: Ontamalimab 25 mg then 75 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 3 years.

    Subject analysis set title
    CD: Ontamalimab 75 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Subject analysis sets values
    		 UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg
    Number of subjects
    159
    268
    10
    13
    Age Categorical
    Units: Subjects
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
    0
        Male
    0
    0
    0
    0
    Age categorical
    Units: Subjects
        <= 18 years
    0
    0
    0
    0
        Between 18 and 65
    0
    0
    0
    0
        >= 65 years
    0
    0
    0
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
    0
    0
    0
        Not Hispanic or Latino
    0
    0
    0
    0
        Unknown or Not Reported
    0
    0
    0
    0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    0
    0
    0
        Asian
    0
    0
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
    0
    0
        Black or African American
    0
    0
    0
    0
        White
    0
    0
    0
    0
        More than one race
    0
    0
    0
    0
        Unknown or Not Reported
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    UC: Ontamalimab 25 mg
    Reporting group description
    		 Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years

    Reporting group title
    UC: Ontamalimab 25mg then 75 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

    Reporting group title
    UC: Ontamalimab 75mg
    Reporting group description
    		 Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

    Reporting group title
    CD: Ontamalimab 25 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Reporting group title
    CD: Ontamalimab 25 mg then 75 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

    Reporting group title
    CD: Ontamalimab 75 mg
    Reporting group description
    		 Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

    Subject analysis set title
    UC: Ontamalimab 25mg then 75 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 3 years.

    Subject analysis set title
    UC: Ontamalimab 75mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Subject analysis set title
    CD: Ontamalimab 25 mg then 75 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 3 years.

    Subject analysis set title
    CD: Ontamalimab 75 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs) [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product. The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to end of study [EOS] (up to 5.79 years)
    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: Only descriptive analysis was planned for this endpoint.  
    End point values
    		 UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg
    Number of subjects analysed
    89
    159
    268
    5
    10
    26
    Units: participants
        TEAE leading to death
    67
    122
    203
    4
    8
    17
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Infections

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    End point title
    		 Number of Participants With Serious Infections [2]
    End point description
    Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator’s assessment. The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to EOS (up to 5.79 years)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.  
    End point values
    		 UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg
    Number of subjects analysed
    89
    159
    268
    5
    10
    26
    Units: participants
    5
    4
    17
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time

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    End point title
    		 Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time [3]
    End point description
    Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported. The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to EOS (up to 5.79 years)
    Notes
    [3] - 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: Only descriptive analysis was planned for this endpoint.  
    End point values
    		 UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg
    Number of subjects analysed
    89
    159
    268
    5
    10
    26
    Units: participants
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time

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    End point title
    		 Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time [4]
    End point description
    ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported. The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to EOS (up to 5.79 years)
    Notes
    [4] - 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: Only descriptive analysis was planned for this endpoint.  
    End point values
    		 UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg
    Number of subjects analysed
    89
    159
    268
    5
    10
    26
    Units: participants
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Discernible Changes in Vital Signs Over Time

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    End point title
    		 Number of Participants With Discernible Changes in Vital Signs Over Time [5]
    End point description
    Vital sign assessments included blood pressure, pulse, respiratory rate and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to EOS (up to 5.79 years)
    Notes
    [5] - 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: Only descriptive analysis was planned for this endpoint.  
    End point values
    		 UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg
    Number of subjects analysed
    89
    159
    268
    5
    10
    26
    Units: participants
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Ulcerative Colitis With Treatment Response Over Time

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    End point title
    		 Number of Participants With Ulcerative Colitis With Treatment Response Over Time [6]
    End point description
    Treatment response over time=clinical composite score that has decreased by greater than or equal to (≥2) points & ≥30 percentage (%), with accompanying decrease in sub score for rectal bleeding (RB) ≥1 point/subscore for RB ≤1, and/or composite score that has decreased by ≥30% & ≥3 points compared to baseline value for induction studies. Clinical composite score is measure consisting of sub scores RB(0-3) plus stool frequency(0-3) with higher scores=more severe disease. With implementation of protocol amendment 4 this study became a single arm study with all participants receiving 75 mg ontamalimab. Hence, only those UC participants who were receiving 75 mg ontamalimab Q4W & participating in amendment 4 were analyzed. Full Analysis Set (FAS) included all participants in the randomised set who received at least 1 dose of IP in the SHP647-304 study. Number of subjects analysed is the number of UC participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Up to 5.79 years
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: With the implementation of amendment 4 of the protocol the study became a single arm study with all participants receiving the 75 mg dose of ontamalimab. Hence, only those UC participants who were receiving the 75 mg dose of ontamalimab every 4 weeks and participating in amendment 4 of the protocol were analyzed in this outcome measure.
    End point values
    		 UC: Ontamalimab 25mg then 75 mg UC: Ontamalimab 75mg
    Number of subjects analysed
    120
    133
    Units: participants
    116
    129
    No statistical analyses for this end point

    Secondary: Number of Participants With Crohn’s Disease With Treatment Response Over Time

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    End point title
    		 Number of Participants With Crohn’s Disease With Treatment Response Over Time [7]
    End point description
    Treatment response over time=Crohn’s Disease Activity Index(CDAI)score that has decreased≥100 points and/or simple endoscopic score for Crohn’s disease(SES-CD)that has decreased by ≥25%,both compared to baseline value for induction studies.SES-CD is simple scoring system with 4 endoscopic variables measured in same 5 ileocolonic segments as CD index of severity. Overall values on SES-CD range from 0-56,higher values=more severe disease.4 endoscopic variables are scored from 0-3 in each bowel segment:ileum,right/transverse/left colon,rectum. Presence & size of ulcers(none=0;diameter 0.1-0.5centimeter(cm)=1;0.5-2cm=2;>2cm=3);extent of ulcerated surface(none=0;<10%=1;10%-30%=2; >30%= 3);extent of affected surface(none=0;<50%=1;50%-75%=2;>75%=3);Presence & type of narrowing (none=0;single can be passed=1;multiple can be passed=2;cannot be passed=3). Only those CD participants who were part of arm groups that began receiving ontamalimab 75mg, Q4W,were analysed in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 5.79 years
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: With implementation of protocol amendment 4 this became a single arm study with all participants receiving 75 mg ontamalimab. Hence, only those CD participants who were receiving ontamalimab 75mg Q4W and participating in amendment 4 of the protocol were analyzed.
    End point values
    		 CD: Ontamalimab 25 mg then 75 mg CD: Ontamalimab 75 mg
    Number of subjects analysed
    6
    13
    Units: participants
    6
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to EOS (up to 5.79 years)
    Adverse event reporting additional description
    Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    UC: Ontamalimab 25 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Reporting group title
    UC: Ontamalimab 25mg then 75 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

    Reporting group title
    CD: Ontamalimab 75 mg
    Reporting group description
    		 Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

    Reporting group title
    CD: Ontamalimab 25 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Reporting group title
    CD: Ontamalimab 25 mg then 75 mg
    Reporting group description
    		 Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

    Reporting group title
    UC: Ontamalimab 75mg
    Reporting group description
    		 Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

    Serious adverse events
    		 UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg CD: Ontamalimab 75 mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg UC: Ontamalimab 75mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 89 (16.85%)
    21 / 159 (13.21%)
    4 / 26 (15.38%)
    2 / 5 (40.00%)
    2 / 10 (20.00%)
    46 / 268 (17.16%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
    3
         number of deaths resulting from adverse events
    0
    0
    0
    1
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acoustic neuroma
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melanocytic naevus
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Vena cava thrombosis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 159 (1.26%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    4 / 268 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Uveitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    6 / 89 (6.74%)
    3 / 159 (1.89%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    10 / 268 (3.73%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    4 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon dysplasia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash generalised
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria chronic
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    4 / 268 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus gastrointestinal infection
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    3 / 268 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    3 / 268 (1.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 UC: Ontamalimab 25 mg UC: Ontamalimab 25mg then 75 mg CD: Ontamalimab 75 mg CD: Ontamalimab 25 mg CD: Ontamalimab 25 mg then 75 mg UC: Ontamalimab 75mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 89 (52.81%)
    109 / 159 (68.55%)
    14 / 26 (53.85%)
    3 / 5 (60.00%)
    8 / 10 (80.00%)
    155 / 268 (57.84%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon adenoma
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 89 (3.37%)
    12 / 159 (7.55%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    13 / 268 (4.85%)
         occurrences all number
    3
    12
    0
    0
    0
    14
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 89 (4.49%)
    9 / 159 (5.66%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    13 / 268 (4.85%)
         occurrences all number
    8
    10
    2
    0
    0
    23
    Immune system disorders
    Rubber sensitivity
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 89 (0.00%)
    9 / 159 (5.66%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    5 / 268 (1.87%)
         occurrences all number
    0
    11
    0
    0
    0
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 89 (1.12%)
    2 / 159 (1.26%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    8 / 268 (2.99%)
         occurrences all number
    1
    2
    0
    0
    1
    11
    Anxiety disorder
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 159 (1.26%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    3 / 268 (1.12%)
         occurrences all number
    0
    2
    0
    0
    1
    3
    Blood pressure increased
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 89 (1.12%)
    3 / 159 (1.89%)
    0 / 26 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    5 / 268 (1.87%)
         occurrences all number
    1
    3
    0
    1
    0
    5
    Migraine
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 159 (1.26%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    4 / 268 (1.49%)
         occurrences all number
    0
    2
    0
    0
    1
    5
    Headache
         subjects affected / exposed
    3 / 89 (3.37%)
    16 / 159 (10.06%)
    3 / 26 (11.54%)
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    10 / 268 (3.73%)
         occurrences all number
    3
    23
    3
    1
    1
    22
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 89 (7.87%)
    14 / 159 (8.81%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    16 / 268 (5.97%)
         occurrences all number
    7
    22
    1
    0
    0
    23
    Leukopenia
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    2 / 26 (7.69%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    Eye disorders
    Eyelid rash
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Uveitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Optic nerve disorder
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 89 (3.37%)
    17 / 159 (10.69%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    10 / 268 (3.73%)
         occurrences all number
    4
    25
    1
    0
    1
    16
    Dental caries
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 159 (0.00%)
    1 / 26 (3.85%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    1
    0
    1
    1
    0
    1
    Crohn's disease
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    3 / 26 (11.54%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    4
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 159 (0.63%)
    0 / 26 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    3 / 268 (1.12%)
         occurrences all number
    0
    1
    0
    1
    0
    4
    Colitis ulcerative
         subjects affected / exposed
    22 / 89 (24.72%)
    21 / 159 (13.21%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    28 / 268 (10.45%)
         occurrences all number
    29
    27
    0
    0
    0
    40
    Anal fistula
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 159 (0.63%)
    3 / 26 (11.54%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    1
    4
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    2 / 89 (2.25%)
    11 / 159 (6.92%)
    2 / 26 (7.69%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    8 / 268 (2.99%)
         occurrences all number
    2
    18
    2
    0
    0
    10
    Dry mouth
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Tongue blistering
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 159 (0.63%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    2
    1
    1
    0
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 89 (1.12%)
    3 / 159 (1.89%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 268 (0.37%)
         occurrences all number
    1
    4
    0
    0
    1
    1
    Dyspepsia
         subjects affected / exposed
    2 / 89 (2.25%)
    10 / 159 (6.29%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    9 / 268 (3.36%)
         occurrences all number
    2
    16
    1
    0
    1
    11
    Nausea
         subjects affected / exposed
    0 / 89 (0.00%)
    11 / 159 (6.92%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    5 / 268 (1.87%)
         occurrences all number
    0
    13
    0
    0
    0
    6
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 159 (1.26%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    4 / 268 (1.49%)
         occurrences all number
    0
    2
    0
    0
    1
    4
    Night sweats
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 89 (0.00%)
    4 / 159 (2.52%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    4
    1
    0
    1
    0
    Back pain
         subjects affected / exposed
    1 / 89 (1.12%)
    11 / 159 (6.92%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    10 / 268 (3.73%)
         occurrences all number
    2
    18
    1
    0
    3
    11
    Arthritis enteropathic
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Arthralgia
         subjects affected / exposed
    3 / 89 (3.37%)
    10 / 159 (6.29%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    13 / 268 (4.85%)
         occurrences all number
    3
    14
    1
    0
    3
    20
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    Influenza
         subjects affected / exposed
    2 / 89 (2.25%)
    5 / 159 (3.14%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    16 / 268 (5.97%)
         occurrences all number
    2
    5
    0
    0
    0
    18
    Gastroenteritis
         subjects affected / exposed
    0 / 89 (0.00%)
    8 / 159 (5.03%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    6 / 268 (2.24%)
         occurrences all number
    0
    8
    2
    0
    1
    8
    Diverticulitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    2 / 26 (7.69%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    Corona virus infection
         subjects affected / exposed
    2 / 89 (2.25%)
    40 / 159 (25.16%)
    4 / 26 (15.38%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    57 / 268 (21.27%)
         occurrences all number
    2
    46
    4
    0
    2
    62
    Bronchitis
         subjects affected / exposed
    0 / 89 (0.00%)
    9 / 159 (5.66%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    8 / 268 (2.99%)
         occurrences all number
    0
    10
    0
    0
    3
    10
    Nasopharyngitis
         subjects affected / exposed
    2 / 89 (2.25%)
    18 / 159 (11.32%)
    3 / 26 (11.54%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    20 / 268 (7.46%)
         occurrences all number
    2
    23
    6
    0
    0
    27
    Sinusitis
         subjects affected / exposed
    0 / 89 (0.00%)
    6 / 159 (3.77%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    4 / 268 (1.49%)
         occurrences all number
    0
    10
    1
    0
    2
    4
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 89 (1.12%)
    3 / 159 (1.89%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    4 / 268 (1.49%)
         occurrences all number
    1
    3
    0
    0
    2
    6
    Respiratory tract infection
         subjects affected / exposed
    1 / 89 (1.12%)
    4 / 159 (2.52%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    4 / 268 (1.49%)
         occurrences all number
    1
    4
    0
    0
    1
    4
    Pyelonephritis acute
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    3 / 89 (3.37%)
    2 / 159 (1.26%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    9 / 268 (3.36%)
         occurrences all number
    3
    2
    0
    0
    1
    13
    Tooth abscess
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 159 (1.26%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 89 (3.37%)
    9 / 159 (5.66%)
    1 / 26 (3.85%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    16 / 268 (5.97%)
         occurrences all number
    3
    15
    1
    0
    0
    19
    Viral pharyngitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    2 / 268 (0.75%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    Vestibular neuronitis
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 159 (0.00%)
    0 / 26 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2017
    The following changes were made as per Amendment 1: 1. Revised study title to reflect inclusion of participants with Crohn’s disease. 2. Updated approximate number of sites and countries in which this study will be conducted. 3. Updated the projected number of participants to reflect inclusion of participants with CD entering from Studies SHP647-305, SHP647-306, and SHP647-307. 4. Added inclusion and exclusion criteria for participants with CD entering from studies SHP647-305, SHP647-306, and SHP647-307. 5. Revised definition of safety analysis set to reflect inclusion of participants with CD entering from Studies SHP647-305, SHP647-306, and SHP647-307. 6. Added definition for FAS. 7. Revised expected duration of study to reflect inclusion of participants with CD. 5. Updated inclusion and exclusion criteria.
    14 Sep 2018
    The following changes were made as per Amendment 2: 1. Added text to clarify that a participant’s maximum duration of treatment is expected to be 7 years, subject to local or country requirements. 2. Updated exclusion criteria. 3. Added pregnancy as a reason that a participant may be withdrawn from study treatment.
    06 Nov 2019
    The following changes were made as per Amendment 3: 1. Updated total sample size projected for the enrollment in the study. 2. Added inclusion and exclusion criteria for UC participants entering directly. 3. Added visit numbers to the schedules of assessments. 4. Updated endpoints to reflect inclusion of direct-entry UC participants.
    21 Sep 2020
    The following changes were made as per Amendment 4: 1. Removed direct entry of participants with UC. 2. Changed the safety follow-up period from 16 weeks to 12 weeks. 3. Revised total sample size projection. 4. Updated the number of sites and the countries in which the study will be conducted. 5. Added a secondary objective to evaluate the maintenance of response to long-term treatment with ontamalimab as measured by the clinical composite score (for participants with UC) or CDAI score (for participants with CD) and biomarkers, with or without endoscopy. 6. Updated the time of study completion from approximately 7 years to no more than 3 years (ie, a participant’s participation is not expected to extend beyond 2023). 7. Updated inclusion and criteria.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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