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    Clinical Trial Results:
    A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

    Summary
    EudraCT number
    2017-000573-37
    Trial protocol
    IE   GB   DE   AT   LT   CZ   NL   SK   BG   GR   PL   BE   ES   PT   HU   EE   HR   IT   RO  
    Global end of trial date
    01 Jul 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHP647-303
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03290781
    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, ClinicalTransparency@takeda.com
    Scientific contact
    Study Director, Shire, ClinicalTransparency@takeda.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
    01 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of subject reported symptoms and centrally read endoscopy, in subjects with moderate to severe Ulcerative Colitis (UC).
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996) and E6 R2 (2017), EU Directive 2001/20/EC, the principles of the Declaration of Helsinki, as well as other applicable national ethical and legal requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Apr 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    30 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 2
    Country: Number of subjects enrolled
    Bulgaria: 11
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Colombia: 2
    Country: Number of subjects enrolled
    Croatia: 10
    Country: Number of subjects enrolled
    Czechia: 12
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Japan: 18
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Lebanon: 1
    Country: Number of subjects enrolled
    Lithuania: 3
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Poland: 95
    Country: Number of subjects enrolled
    Portugal: 8
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    Russian Federation: 27
    Country: Number of subjects enrolled
    Slovakia: 9
    Country: Number of subjects enrolled
    South Africa: 6
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Ukraine: 38
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 48
    Worldwide total number of subjects
    366
    EEA total number of subjects
    198
    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)
    5
    Adults (18-64 years)
    336
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 400 sites from 4 April 2018 (first subject first visit) to 1 July 2021 (last subject last visit). A total of 366 subjects were enrolled, randomised and received study treatment.

    Pre-assignment
    Screening details
    Subjects with moderate to severe UC who achieved a clinical response and completed their treatment period in the induction studies (either SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) were re-randomised into this study as ontamalimab and placebo responders to receive placebo or ONTA 25 milligrams (mg) or 75 mg.

    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
    ONTA 25mg/Placebo
    Arm description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52 in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Arm title
    ONTA 25mg/ONTA 25mg
    Arm description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Ontamalimab
    Investigational medicinal product code
    SHP647
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Arm title
    ONTA 75mg/Placebo
    Arm description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Arm title
    ONTA 75mg/ONTA 75mg
    Arm description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Ontamalimab
    Investigational medicinal product code
    SHP647
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Arm title
    Placebo/Placebo
    Arm description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Arm title
    Placebo/ONTA 25mg
    Arm description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Ontamalimab
    Investigational medicinal product code
    SHP647
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Arm title
    Placebo/ONTA 75mg
    Arm description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Ontamalimab
    Investigational medicinal product code
    SHP647
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subject received 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Number of subjects in period 1
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg Placebo/Placebo Placebo/ONTA 25mg Placebo/ONTA 75mg
    Started
    73
    71
    86
    82
    11
    22
    21
    Completed
    24
    53
    30
    59
    6
    19
    17
    Not completed
    49
    18
    56
    23
    5
    3
    4
         Protocol Deviation
    2
    -
    -
    1
    -
    -
    -
         Physician decision
    -
    1
    -
    -
    -
    -
    -
         Adverse event, serious fatal
    -
    -
    1
    -
    1
    -
    -
         Adverse event, non-fatal
    5
    7
    4
    1
    -
    -
    -
         Unspecified
    3
    -
    2
    2
    -
    -
    -
         Consent withdrawn by subject
    6
    5
    9
    10
    1
    2
    -
         Site Terminated by Sponsor
    1
    -
    2
    1
    -
    -
    -
         Disease Relapse
    32
    5
    38
    7
    3
    1
    4
         Lost to follow-up
    -
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ONTA 25mg/Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52 in this study.

    Reporting group title
    ONTA 25mg/ONTA 25mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    ONTA 75mg/Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    ONTA 75mg/ONTA 75mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    Placebo/Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    Placebo/ONTA 25mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    Placebo/ONTA 75mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg Placebo/Placebo Placebo/ONTA 25mg Placebo/ONTA 75mg Total
    Number of subjects
    73 71 86 82 11 22 21
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.3 ± 15.40 41.2 ± 13.17 42.0 ± 13.81 42.3 ± 14.21 44.7 ± 14.16 40.9 ± 9.42 39.9 ± 12.10 -
    Gender categorical
    Units: Subjects
        Female
    27 29 35 35 5 9 10 150
        Male
    46 42 51 47 6 13 11 216
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    6 6 4 7 0 3 1 27
        Not Hispanic or Latino
    67 64 82 74 11 19 20 337
        Not Reported
    0 1 0 1 0 0 0 2
        Unknown
    0 0 0 0 0 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    2 0 1 1 0 0 0 4
        Asian
    5 4 5 8 1 2 3 28
        Black or African American
    3 1 2 2 0 0 1 9
        White
    58 62 77 69 10 19 17 312
        Native Hawaiian or Other Pacific Islander
    1 0 0 0 0 0 0 1
        More than one race
    4 2 0 0 0 1 0 7
        Unknown or Not Reported
    0 2 1 2 0 0 0 5

    End points

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    End points reporting groups
    Reporting group title
    ONTA 25mg/Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52 in this study.

    Reporting group title
    ONTA 25mg/ONTA 25mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    ONTA 75mg/Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    ONTA 75mg/ONTA 75mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    Placebo/Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    Placebo/ONTA 25mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Reporting group title
    Placebo/ONTA 75mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

    Primary: Number of Subjects With Remission Based on Composite Score at Week 52

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    End point title
    Number of Subjects With Remission Based on Composite Score at Week 52 [1]
    End point description
    Remission: a composite score of subject reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least 1-point change from induction study baseline; rectal bleeding sub-score of 0; endoscopic sub-score of 0 or 1 (modified, excludes friability). Composite score consisted of Mayo score without Physician global assessment (PGA) sub-score and ranges from 0-9 points. Mayo score was a measure of UC disease activity ranged from 0-12 points with higher scores= severe disease and consisted of 4 sub-scores, each graded from 0-3. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease). Analysis: Ontamalimab responder Full Analysis set (FAS).
    End point type
    Primary
    End point timeframe
    At Week 52
    Notes
    [1] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    6
    38
    11
    33
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.451
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.296
         upper limit
    0.572
    Notes
    [2] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    ONTA 75mg/Placebo v ONTA 75mg/ONTA 75mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.278
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.142
         upper limit
    0.401
    Notes
    [3] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

    Secondary: Number of Subjects With Endoscopic Remission at Week 52

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    End point title
    Number of Subjects With Endoscopic Remission at Week 52 [4]
    End point description
    Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration). The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    At Week 52
    Notes
    [4] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    7
    40
    13
    40
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [5]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.463
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.31
         upper limit
    0.585
    Notes
    [5] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    ONTA 75mg/Placebo v ONTA 75mg/ONTA 75mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.339
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.197
         upper limit
    0.463
    Notes
    [6] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

    Secondary: Number of Subjects With Clinical Remission at Week 52

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    End point title
    Number of Subjects With Clinical Remission at Week 52 [7]
    End point description
    Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this subject, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    At Week 52
    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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    13
    48
    19
    42
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    ONTA 75mg/Placebo v ONTA 75mg/ONTA 75mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.294
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.148
         upper limit
    0.425
    Notes
    [8] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [9]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.497
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.337
         upper limit
    0.62
    Notes
    [9] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

    Secondary: Number of Subjects With Sustained Remission at Week 52

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    End point title
    Number of Subjects With Sustained Remission at Week 52 [10]
    End point description
    Sustained remission was defined as in remission at Week 52 visit, among Subjects who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease). The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    At Week 52
    Notes
    [10] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    4
    23
    7
    22
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [11]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.277
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.129
         upper limit
    0.398
    Notes
    [11] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [12]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.191
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.067
         upper limit
    0.305
    Notes
    [12] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

    Secondary: Number of Subjects With Clinical Response Based on Composite Score at Week 52

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    End point title
    Number of Subjects With Clinical Response Based on Composite Score at Week 52 [13]
    End point description
    Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease. Analysis: Ontamalimab responder FAS.
    End point type
    Secondary
    End point timeframe
    At Week 52
    Notes
    [13] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    15
    49
    20
    47
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [14]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.488
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.329
         upper limit
    0.613
    Notes
    [14] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [15]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.343
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.194
         upper limit
    0.471
    Notes
    [15] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

    Secondary: Number of Subjects With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52

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    End point title
    Number of Subjects With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52 [16]
    End point description
    Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    At Week 52
    Notes
    [16] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    6
    37
    11
    29
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [17]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.431
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.28
         upper limit
    0.554
    Notes
    [17] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [18]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.227
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.094
         upper limit
    0.349
    Notes
    [18] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

    Secondary: Number of Subjects With Glucocorticoid-free Clinical Remission at Week 52

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    End point title
    Number of Subjects With Glucocorticoid-free Clinical Remission at Week 52 [19]
    End point description
    Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among subjects using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes). The ontamalimab responder FAS consisted of all subjects in the randomised set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    At Week 52
    Notes
    [19] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    1
    12
    3
    12
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [20]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.176
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.049
         upper limit
    0.287
    Notes
    [20] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority [21]
    P-value
    < 0.005
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Proportion
    Point estimate
    0.111
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.006
         upper limit
    0.208
    Notes
    [21] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

    Secondary: Number of Subjects With Glucocorticoid-free Remission at Week 52

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    End point title
    Number of Subjects With Glucocorticoid-free Remission at Week 52 [22]
    End point description
    Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among subjects using glucocorticoids at the baseline. Remission was defined as a composite score of subject-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). Composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. Stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Analysis was based on the ontamalimab responder FAS set.
    End point type
    Secondary
    End point timeframe
    At Week 52
    Notes
    [22] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    0
    8
    2
    10
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [23]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [23] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.005 [24]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [24] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

    Secondary: Number of Subjects With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0

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    End point title
    Number of Subjects With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0 [25]
    End point description
    Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this subject, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    Notes
    [25] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
        At Week 4
    28
    25
    25
    24
        At Week 8
    22
    25
    29
    31
        At Week 12
    18
    26
    22
    30
        At Week 16
    16
    32
    17
    35
        At Week 20
    20
    25
    16
    31
        At Week 24
    12
    31
    12
    31
        At Week 28
    13
    31
    19
    32
        At Week 32
    17
    35
    13
    30
        At Week 36
    13
    37
    13
    32
        At Week 40
    15
    34
    12
    25
        At Week 44
    11
    27
    12
    33
        At Week 48
    13
    32
    16
    27
        At Week 52
    9
    33
    10
    30
    No statistical analyses for this end point

    Secondary: Number of Subjects With Sustained Endoscopic Remission at Week 52

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    End point title
    Number of Subjects With Sustained Endoscopic Remission at Week 52 [26]
    End point description
    Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among subjects who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    At Week 52
    Notes
    [26] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    4
    27
    8
    29
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of subjects with TEAEs were reported. The safety set consisted of all subjects who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to follow-up (Week 64)
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg Placebo/Placebo Placebo/ONTA 25mg Placebo/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    11
    22
    21
    Units: Subjects
    46
    41
    54
    51
    8
    11
    12
    No statistical analyses for this end point

    Secondary: Number of Subjects who Developed Positive Antidrug Antibodies to Ontamalimab

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    End point title
    Number of Subjects who Developed Positive Antidrug Antibodies to Ontamalimab
    End point description
    Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of subjects who developed positive results for ontamalimab were reported. The safety set consisted of all subjects who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]). Here, "number of subjects analysed" signifies subjects who were evaluable for this endpoint and "n" refers to subjects who were evaluable at specific time points.
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36 and 52
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg Placebo/Placebo Placebo/ONTA 25mg Placebo/ONTA 75mg
    Number of subjects analysed
    72
    70
    81
    73
    11
    22
    21
    Units: subjects
        At Week 12(n=72,70,81,73,11,20,21)
    7
    6
    8
    4
    2
    0
    4
        At Week 24(n=50,61,63,71,8,22,17)
    6
    5
    5
    4
    1
    0
    1
        At Week 36(n=34,54,49,67,8,22,15)
    5
    3
    2
    4
    2
    1
    2
        At Week 52(n=25,53,31,55,7,15,16)
    1
    2
    6
    4
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Remission Based on Total Mayo Score at Week 52

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    End point title
    Number of Subjects With Remission Based on Total Mayo Score at Week 52 [27]
    End point description
    Remission defined as a total mayo score of <= 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. Total mayo score ranges from 0-12 points and consisted of the following 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0-3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0-3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0-3, where 0=normal or inactive disease; 3=severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).
    End point type
    Secondary
    End point timeframe
    At Week 52
    Notes
    [27] - 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: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
    End point values
    ONTA 25mg/Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg
    Number of subjects analysed
    73
    71
    86
    82
    Units: Subjects
    5
    38
    10
    33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration up to Week 64
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    ONTA 25mg/ Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Reporting group title
    ONTA 25mg/ONTA 25mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Reporting group title
    ONTA 75mg/Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Reporting group title
    ONTA 75mg/ONTA 75mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Reporting group title
    Placebo/Placebo
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Reporting group title
    Placebo/ONTA 25mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Reporting group title
    Placebo/ONTA 75mg
    Reporting group description
    Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

    Serious adverse events
    ONTA 25mg/ Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg Placebo/Placebo Placebo/ONTA 25mg Placebo/ONTA 75mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 73 (8.22%)
    9 / 71 (12.68%)
    9 / 86 (10.47%)
    2 / 82 (2.44%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    2 / 21 (9.52%)
         number of deaths (all causes)
    0
    0
    1
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary thyroid cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    1 / 82 (1.22%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Immune system disorders
    Drug hypersensitivity
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    General disorders and administration site conditions
    Sudden cardiac death
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Chest discomfort
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Reproductive system and breast disorders
    Pelvic pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Uterine polyp
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radius fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    0 / 0
    Joint injury
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Investigations
    Clostridium test positive
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    0 / 0
    International normalised ratio increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 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
    0 / 0
    Cardiac disorders
    Myocardial infarction
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Hypochromic anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Iron deficiency anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal septum deviation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Pulmonary embolism
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Respiratory failure
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Rhinitis hypertrophic
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Nervous system disorders
    Facial paralysis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Nerve compression
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Transient global amnesia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 73 (2.74%)
    1 / 71 (1.41%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    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
    0 / 0
    Large intestine perforation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder metaplasia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    0 / 0
    Infections and infestations
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    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
    0 / 0
    Appendicitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    1 / 82 (1.22%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Infectious colitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Peritonitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Tracheobronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    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
    0 / 0
    Sepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    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
    ONTA 25mg/ Placebo ONTA 25mg/ONTA 25mg ONTA 75mg/Placebo ONTA 75mg/ONTA 75mg Placebo/Placebo Placebo/ONTA 25mg Placebo/ONTA 75mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 73 (56.16%)
    27 / 71 (38.03%)
    52 / 86 (60.47%)
    30 / 82 (36.59%)
    8 / 11 (72.73%)
    11 / 22 (50.00%)
    9 / 21 (42.86%)
    Vascular disorders
    Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 73 (4.11%)
    3 / 71 (4.23%)
    0 / 86 (0.00%)
    2 / 82 (2.44%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    3
    3
    0
    2
    1
    0
    1
    Injury, poisoning and procedural complications
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Investigations
    Weight increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    White blood cell count decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    2 / 22 (9.09%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    0
    Cardiac disorders
    Arrhythmia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 73 (2.74%)
    4 / 71 (5.63%)
    3 / 86 (3.49%)
    1 / 82 (1.22%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    4
    3
    1
    1
    0
    0
    Lymphopenia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Leukopenia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    1 / 82 (1.22%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    0
    0
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 73 (5.48%)
    3 / 71 (4.23%)
    0 / 86 (0.00%)
    3 / 82 (3.66%)
    1 / 11 (9.09%)
    3 / 22 (13.64%)
    1 / 21 (4.76%)
         occurrences all number
    5
    4
    0
    3
    1
    7
    1
    General disorders and administration site conditions
    Oedema peripheral
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    2 / 71 (2.82%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    1
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 73 (4.11%)
    2 / 71 (2.82%)
    4 / 86 (4.65%)
    3 / 82 (3.66%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    3
    4
    4
    3
    1
    0
    0
    Colitis ulcerative
         subjects affected / exposed
    17 / 73 (23.29%)
    3 / 71 (4.23%)
    29 / 86 (33.72%)
    6 / 82 (7.32%)
    4 / 11 (36.36%)
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    17
    4
    35
    7
    4
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    4 / 73 (5.48%)
    4 / 71 (5.63%)
    3 / 86 (3.49%)
    3 / 82 (3.66%)
    0 / 11 (0.00%)
    1 / 22 (4.55%)
    3 / 21 (14.29%)
         occurrences all number
    5
    5
    3
    3
    0
    1
    4
    Metabolism and nutrition disorders
    Diabetes mellitus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    Infections and infestations
    Corona virus infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    1 / 22 (4.55%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    2
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 73 (5.48%)
    3 / 71 (4.23%)
    3 / 86 (3.49%)
    6 / 82 (7.32%)
    2 / 11 (18.18%)
    1 / 22 (4.55%)
    1 / 21 (4.76%)
         occurrences all number
    4
    4
    3
    7
    2
    1
    1
    Respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    2 / 86 (2.33%)
    2 / 82 (2.44%)
    1 / 11 (9.09%)
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    2
    2
    1
    1
    0
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 71 (1.41%)
    4 / 86 (4.65%)
    3 / 82 (3.66%)
    0 / 11 (0.00%)
    2 / 22 (9.09%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    4
    5
    0
    2
    0
    Viral infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    1 / 11 (9.09%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Sep 2018
    Protocol Amendment 1: - Added a statement to note that subjects who are withdrawn early from the study due to fulfilling the criteria for treatment failure also may be eligible to enter the long-term safety study, SHP647-304. - Added a statement to clarify the timing of the Week 52/ET visit (Visit 14, Part 2) for subjects who fulfilled the criteria for treatment failure and would be entering the long-term safety study. - Added new section describing benefit and risk of SHP647 treatment. - Added pregnancy to the list of reasons a subject may be withdrawn from study treatment. - Added new section describing safety monitoring and stopping algorithms for elevated hepatic blood tests.
    11 Nov 2019
    Protocol Amendment 2: - Updated sample size projections and power considerations to reflect a decrease in the sample size due to a reduction in the targeted power to detect an individual pairwise treatment difference at a highly statistically persuasive level (i.e., a p-value <=.001) in the primary endpoint from 90% to 85% for feasibility reasons. - Updated the text to correctly describe the scoring of subject-reported UC sign and symptom data. - Added text to indicate that adverse events of special interest will be summarized by treatment group. - Added PRO-UC daily e-diary data collection at Visit 14 (Part 2) to reflect that e-diary data were to be collected through Visit 14 (Part 2) to calculate the primary endpoint. - Revised to extend the window between the coloscopy procedure at Visit 14 (Part 1) and Visit 14 (Part 2) to 10 days, although 5 to 7 days is preferable. - Added new subsection to clarify that infectious etiology must be evaluated when a subject experiences an increase in gastrointestinal symptoms. - Added new subsection to describe classification of hypersensitivity as an adverse event of special interest. - Added language to clarify treatment failure criteria and assessment and reflect that treatment failure could be a reason for subject withdrawal. - Added that oral beclomethasone up to a maximum of 5 mg/day was permitted.
    17 Sep 2020
    Protocol Amendment 3: - Changed the safety follow-up period from 16 weeks to 12 weeks due to the emergent data on the half-life of ontamalimab (16 days). - Added footnote to specify that subjects performing home administrations consecutively for 3 months will need to perform liver function testing locally. - Updated to reflect the discontinuation of ontamalimab Phase 3 clinical development program as follows: - Specified that the subject’s next scheduled visit would be the Week 52/ET visit and clarified the timing of the Week 52/ET visit. - Added language to clarify that, with the early termination of the study by the sponsor, endoscopy was optional for subjects who received less than 52 weeks of treatment.

    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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