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    Clinical Trial Results:
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

    Summary
    EudraCT number
    2017-000572-28
    Trial protocol
    IE   HU   SK   BG   GR   BE   ES   PT   FR  
    Global end of trial date
    06 Oct 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Apr 2021
    First version publication date
    12 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHP647-302
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03259308
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 ShireWay, 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
    06 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of ontamalimab in inducing 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), the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Dec 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    4 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 2
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Colombia: 6
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 28
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Japan: 16
    Country: Number of subjects enrolled
    Korea, Republic of: 17
    Country: Number of subjects enrolled
    Lebanon: 1
    Country: Number of subjects enrolled
    Mexico: 14
    Country: Number of subjects enrolled
    New Zealand: 3
    Country: Number of subjects enrolled
    Portugal: 8
    Country: Number of subjects enrolled
    Slovakia: 15
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Ukraine: 77
    Country: Number of subjects enrolled
    United States: 51
    Worldwide total number of subjects
    279
    EEA total number of subjects
    86
    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)
    1
    Adults (18-64 years)
    258
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 205 sites between 5 December 2017 (first subject first visit) and 06 October 2020 (last subject last visit).

    Pre-assignment
    Screening details
    A total of 279 subjects were enrolled and randomized in this study.

    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
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
    Arm type
    Placebo

    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 SC injection, using a PFS.

    Arm title
    Ontamalimab 25 mg
    Arm description
    Subjects received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
    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 SC injection, using a PFS.

    Arm title
    Ontamalimab 75 mg
    Arm description
    Subjects received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
    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 SC injection, using a PFS.

    Number of subjects in period 1
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Started
    56
    111
    112
    Completed
    49
    103
    105
    Not completed
    7
    8
    7
         Protocol Deviation
    -
    3
    -
         Lack of efficacy
    -
    -
    1
         Pregnancy
    -
    -
    1
         Adverse event, non-fatal
    5
    4
    1
         Consent withdrawn by subject
    2
    1
    3
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.

    Reporting group title
    Ontamalimab 25 mg
    Reporting group description
    Subjects received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.

    Reporting group title
    Ontamalimab 75 mg
    Reporting group description
    Subjects received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.

    Reporting group values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg Total
    Number of subjects
    56 111 112 279
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    41.6 ± 13.50 43.5 ± 14.16 43.9 ± 13.08 -
    Sex: Female, Male
    Units: Subjects
        Female
    23 46 45 114
        Male
    33 65 67 165
    Race, Customized
    Units: Subjects
        American Indian or Alaska Native
    0 5 3 8
        Asian: Japanese
    6 5 6 17
        Asian: Korean
    4 5 8 17
        Asian: Other
    1 0 0 1
        Black or African American
    2 4 1 7
        White
    41 85 88 214
        Native Hawaiian or Other Pacific Islander
    0 1 0 1
        Multiple
    1 5 1 7
        Other (Unspecified)
    1 1 5 7
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    5 17 16 38
        Not Hispanic or Latino
    51 93 96 240
        Unknown or Not Reported
    0 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.

    Reporting group title
    Ontamalimab 25 mg
    Reporting group description
    Subjects received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.

    Reporting group title
    Ontamalimab 75 mg
    Reporting group description
    Subjects received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.

    Primary: Number of Subjects With Remission Based on Composite Score at Week 12

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    End point title
    Number of Subjects With Remission Based on Composite Score at Week 12
    End point description
    Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure derived from the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); physician global assessment (0-3). Full analysis set (FAS) consisted of all subjects in the randomized set who had received at least 1 dose of investigational product (IP).
    End point type
    Primary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    7
    30
    33
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.027 [1]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - P-value was based on Cochran-Mantel- Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Ontamalimab 75 mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.014 [2]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.

    Secondary: Number of Subjects With Endoscopic Remission at Week 12

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    End point title
    Number of Subjects With Endoscopic Remission at Week 12
    End point description
    Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    7
    39
    38
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001 [3]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Ontamalimab 75 mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003 [4]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.

    Secondary: Number of Subjects With Clinical Remission at Week 12

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    End point title
    Number of Subjects With Clinical Remission at Week 12
    End point description
    Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score ranged from 0 to 3 with higher scores indicating more severe disease. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    10
    50
    56
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [5]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [5] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Ontamalimab 75 mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.

    Secondary: Number of Subjects With Clinical Response Based on Composite Score at Week 12

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    End point title
    Number of Subjects With Clinical Response Based on Composite Score at Week 12
    End point description
    Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (>=) 1 point or a sub-score for rectal bleeding less than or equal to (<=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3). FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    16
    67
    64
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Ontamalimab 75 mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [7]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [7] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [8]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [8] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.

    Secondary: Number of Subjects With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12

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    End point title
    Number of Subjects With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12
    End point description
    Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of Mayo score ranged 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 equal to (=) 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 indicating more severe disease. Number of subjects with mucosal healing based on endoscopic and histological assessment using the Geboes score grading system were reported. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    6
    35
    30
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002 [9]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [9] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Ontamalimab 75 mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.017 [10]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [10] - P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.

    Secondary: Number of Subjects With Remission Based on Total Mayo Score at Week 12

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    End point title
    Number of Subjects With Remission Based on Total Mayo Score at Week 12
    End point description
    Remission was defined as a total Mayo score of <=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excluded friability], and PGA) exceeding 1, at the Week 12. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3). FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    5
    28
    26
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Response Based on Total Mayo Score at Week 12

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    End point title
    Number of Subjects With Clinical Response Based on Total Mayo Score at Week 12
    End point description
    Clinical response (Mayo) was defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or an absolute sub-score for rectal bleeding <=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3). FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    19
    66
    63
    No statistical analyses for this end point

    Secondary: Number of Subjects With Partial Mayo Score <=2 With no Individual Sub-score Greater than (>) 1 at Weeks 4, 8, and 12

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    End point title
    Number of Subjects With Partial Mayo Score <=2 With no Individual Sub-score Greater than (>) 1 at Weeks 4, 8, and 12
    End point description
    The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Weeks 4, 8, and 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
        At Week 4
    6
    26
    23
        At Week 8
    12
    53
    41
        At Week 12
    10
    49
    52
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8

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    End point title
    Number of Subjects With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8
    End point description
    Number of subjects were reported who with stool frequency sub-scores of 0 or 1 and rectal bleeding sub-score of 0. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1- point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Weeks 4 and 8
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
        At Week 4
    4
    28
    22
        At Week 8
    10
    52
    41
    No statistical analyses for this end point

    Secondary: Number of Subjects With Endoscopic Remission With Sub-score of 0 at Week 12

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    End point title
    Number of Subjects With Endoscopic Remission With Sub-score of 0 at Week 12
    End point description
    Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    1
    14
    14
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Week 4, 8, and 12

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    End point title
    Number of Subjects With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Week 4, 8, and 12
    End point description
    Number of subjects were reported with rectal bleeding and stool frequency sub-scores of 0. Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 4, 8, and 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
        At Week 4
    0
    15
    12
        At Week 8
    5
    29
    19
        At Week 12
    6
    36
    26
    No statistical analyses for this end point

    Secondary: Number of Subjects With Deep Remission at Week 12

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    End point title
    Number of Subjects With Deep Remission at Week 12
    End point description
    Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score <=1 and a centrally read Geboes score of <=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. 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 indicating more severe disease. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
    1
    11
    9
    No statistical analyses for this end point

    Secondary: Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12

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    End point title
    Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12
    End point description
    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Subjects asked to record data of abdominal pain worst severity, over previous 24 hours, in the e-diary. Subjects signs and symptom average scores at each scheduled visit were calculated based on data recorded over most recent 3 days (consecutive or non-consecutive) of last 10 days prior to scheduled visit start date excluding following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy and 2 days after day of endoscopy. Abdominal pain’s worst severity assessment was based on 11-point numerical rating scale with 0-No pain and 10-Worst imaginable pain over the previous 24 hours. Higher scores indicating more severe pain. Analysis was performed using FAS. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    47
    104
    107
    Units: Score on a scale
        least squares mean (standard error)
    -1.69 ± 0.309
    -2.49 ± 0.218
    -1.83 ± 0.215
    No statistical analyses for this end point

    Secondary: Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12

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    End point title
    Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
    End point description
    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Subjects were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Subjects signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements. Analysis was performed using FAS. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    47
    104
    107
    Units: Score on a Scale
        least squares mean (standard error)
    -1.41 ± 0.405
    -3.50 ± 0.286
    -2.87 ± 0.284
    No statistical analyses for this end point

    Secondary: Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12 at Week 12

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    End point title
    Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12 at Week 12
    End point description
    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Subjects were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Subjects signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0-27. Higher scores indicating more frequent bowel movements. Analysis was performed using FAS. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    47
    104
    107
    Units: Score on a Scale
        least squares mean (standard error)
    -1.09 ± 0.373
    -2.87 ± 0.263
    -2.56 ± 0.264
    No statistical analyses for this end point

    Secondary: Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12

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    End point title
    Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
    End point description
    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Subjects were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Subjects signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0-27. Higher scores indicating more frequent bowel movements. Analysis was performed using FAS. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    47
    104
    107
    Units: Score on a Scale
        least squares mean (standard error)
    -1.26 ± 0.386
    -3.32 ± 0.272
    -2.97 ± 0.272
    No statistical analyses for this end point

    Secondary: Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12

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    End point title
    Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12
    End point description
    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Subjects asked to record data for average number of bowel movements with blood, as experienced over the previous 24 hours. Subjects signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements with blood. Analysis was performed using FAS. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    47
    104
    107
    Units: Score on a Scale
        least squares mean (standard error)
    -2.05 ± 0.379
    -3.74 ± 0.267
    -3.41 ± 0.265
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12

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    End point title
    Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12
    End point description
    Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    47
    104
    107
    Units: Score on a Scale
        least squares mean (standard error)
    -1.15 ± 0.246
    -2.32 ± 0.173
    -2.00 ± 0.172
    No statistical analyses for this end point

    Secondary: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12

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    End point title
    Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12
    End point description
    IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific health-related quality of life (HRQL) in subjects with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms (BS): 10 to 70; Systemic symptoms (SS): 5 to 35; Emotional function (EF): 12 to 84; Social function (SF): 5 to 35. Higher scores indicating a better quality of life. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint and n=number analysed refer to subjects evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8 and 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    53
    108
    106
    Units: Score on a Scale
    least squares mean (standard error)
        BF: Change at Week 8 (n=53, 108, 106)
    9.59 ± 1.611
    16.66 ± 1.189
    15.36 ± 1.180
        BF: Change at Week 12 (n=50, 104, 106)
    9.51 ± 1.707
    17.71 ± 1.250
    15.86 ± 1.232
        ES: Change at Week 8(n=53, 108, 106)
    8.91 ± 1.701
    15.18 ± 1.255
    14.41 ± 1.247
        ES: Change at Week 12(n=50, 104, 106)
    9.94 ± 1.861
    14.84 ± 1.359
    14.73 ± 1.341
        SS: Change at Week 8 (n=53, 108, 106)
    3.84 ± 0.759
    6.61 ± 0.561
    5.86 ± 0.557
        SS: Change at Week 12(n=50, 104, 106)
    3.85 ± 0.814
    7.34 ± 0.596
    6.04 ± 0.587
        SF: Change at Week 8(n=53, 108, 106)
    5.06 ± 0.873
    6.97 ± 0.643
    6.75 ± 0.640
        SF: Change at Week 12 (n=50, 104, 106)
    5.09 ± 0.926
    7.68 ± 0.677
    7.03 ± 0.668
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Scores in IBDQ at Weeks 8 and 12

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    End point title
    Change From Baseline in Total Scores in IBDQ at Weeks 8 and 12
    End point description
    IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in subjects with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement. FAS: all subjects in the randomized set who had received at least 1 dose of IP. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint and n=number analysed refer to subjects evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8 and 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    53
    108
    106
    Units: Score on a Scale
    least squares mean (standard error)
        Change at Week 8 (n=53, 108, 106)
    27.56 ± 4.574
    45.63 ± 3.380
    42.58 ± 3.358
        Change at Week 12 (n=50, 104, 106)
    28.39 ± 4.990
    47.75 ± 3.649
    43.85 ± 3.604
    No statistical analyses for this end point

    Secondary: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12

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    End point title
    Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12
    End point description
    SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of subjects. SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains; PCS score (physical functioning, role-physical, bodily pain, general health) and MCS score (vitality, social functioning, role-emotional, mental health). Scores ranged from 0 to 100.Higher scores indicating better HRQL. Analysis was performed using FAS. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    50
    104
    106
    Units: Score on a Scale
    least squares mean (standard error)
        Mental Component: Change at Week 12
    2.09 ± 1.301
    7.37 ± 0.949
    6.68 ± 0.935
        Physical Component: Change at Week 12
    4.84 ± 0.982
    6.45 ± 0.721
    5.54 ± 0.709
    No statistical analyses for this end point

    Secondary: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12

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    End point title
    Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12
    End point description
    SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of subjects. Generic instruments were used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]), with scores ranged from 0 to 100. Higher scores indicating better HRQL. Analysis was performed using FAS. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    50
    104
    106
    Units: Score on a Scale
    least squares mean (standard error)
        Physical Functioning: Change at Week 12
    3.40 ± 0.901
    5.03 ± 0.657
    3.79 ± 0.646
        Role-Physical: Change at Week 12
    4.47 ± 1.205
    7.39 ± 0.884
    6.90 ± 0.874
        Bodily Pain: Change at Week 12
    5.55 ± 1.293
    8.18 ± 0.941
    7.06 ± 0.926
        General Health: Change at Week 12
    3.93 ± 1.203
    7.00 ± 0.880
    6.34 ± 0.865
        Vitality: Change at Week 12
    3.59 ± 1.381
    8.23 ± 1.008
    7.43 ± 0.993
        Social Functioning: Change at Week 12
    3.59 ± 1.233
    7.43 ± 0.898
    6.54 ± 0.884
        Role-Emotional: Change at Week 12
    1.27 ± 1.317
    5.79 ± 0.958
    5.68 ± 0.944
        Mental Health: Change at Week 12
    3.56 ± 1.268
    7.90 ± 0.925
    6.47 ± 0.911
    No statistical analyses for this end point

    Secondary: Number of Subjects Based on Inpatient Hospitalization

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    End point title
    Number of Subjects Based on Inpatient Hospitalization
    End point description
    Number of subjects based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, Other illness/problem, and undergo gastrointestinal related procedures during the entire study period were reported. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP.
    End point type
    Secondary
    End point timeframe
    From start of study up to follow up (Week 29)
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    56
    111
    112
    Units: Subjects
        All-Cause Hospitalization
    2
    3
    2
        Gastrointestinal Related
    1
    2
    1
        Other Illness/Problem
    1
    2
    2
        Undergo Gastrointestinal Related Procedures
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Median Duration of Total Inpatient Days

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    End point title
    Median Duration of Total Inpatient Days
    End point description
    Inpatient days were calculated as date of discharge - date of admission + 1. Median duration of total inpatient days during the entire study period was reported. FAS consisted of all subjects in the randomized set who had received at least 1 dose of IP. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From start of study up to follow-up (Week 29)
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    2
    3
    2
    Units: Days
        median (full range (min-max))
    10.5 (6 to 15)
    7.0 (6 to 11)
    2.0 (2 to 2)
    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 follow-up (Week 29)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.

    Reporting group title
    Ontamalimab 25 mg
    Reporting group description
    Subjects received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.

    Reporting group title
    Ontamalimab 75 mg
    Reporting group description
    Subjects received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.

    Serious adverse events
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 56 (7.14%)
    5 / 111 (4.50%)
    3 / 112 (2.68%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 111 (0.90%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 111 (0.90%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 111 (0.90%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 111 (0.90%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 111 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 111 (0.90%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydrocalyx
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 111 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 111 (0.90%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash pustular
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 111 (0.90%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 56 (12.50%)
    5 / 111 (4.50%)
    7 / 112 (6.25%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 111 (1.80%)
    7 / 112 (6.25%)
         occurrences all number
    5
    2
    9
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 56 (7.14%)
    3 / 111 (2.70%)
    2 / 112 (1.79%)
         occurrences all number
    5
    3
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Sep 2018
    Protocol Amendment 1: - Updated exclusion criteria to further define the exclusion of subjects with colitis, a history of positive Mycobacterium tuberculosis (TB), or compromised liver function. - Updated exclusion criteria to indicate exclusion of subjects with prior nonbiologic treatment with immunomodulatory properties or prior apheresis or plasma exchange within the specified timeframe. - Added a new section to provide appropriate guidance on patients who have been enrolled with elevated liver function test (LFT) values or who experience an increase in LFT(s) during the study.
    11 Nov 2019
    Protocol Amendment 2: - Updated text to reflect preliminary results of an ePPND toxicity study in nonhuman primates, which indicated that, at the dose levels tested (30 mg/kg and 60 mg/kg), infant losses were increased in ontamalimab-exposed animals when compared both to control animals in the study and to the historical control animal data from the testing facility. The relevance of this finding to humans was unknown but could not be excluded. - Added text to address FDA recommendation to evaluate the risk of hypersensitivity reactions in the Phase 3 studies and aid in the collection of relevant safety data.

    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.
    The study was terminated as per the sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
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