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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 301)

    Summary
    EudraCT number
    2017-000599-27
    Trial protocol
    DE   AT   LT   CZ   NL   PL   GB   HR   IT  
    Global end of trial date
    23 Oct 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SHP647-301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03259334
    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
    23 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient-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
    09 Feb 2018
    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?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 10
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Croatia: 17
    Country: Number of subjects enrolled
    Czechia: 16
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Italy: 30
    Country: Number of subjects enrolled
    Japan: 14
    Country: Number of subjects enrolled
    Lithuania: 4
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Poland: 164
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Russian Federation: 47
    Country: Number of subjects enrolled
    Serbia: 1
    Country: Number of subjects enrolled
    South Africa: 11
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    378
    EEA total number of subjects
    254
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    346
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 192 sites between 9 February 2018 (first subject first visit) and 23 October 2020 (last subject last visit).

    Pre-assignment
    Screening details
    A total of 380 subjects were enrolled and randomized, of which 2 subjects didn't receive study treatment and 378 subjects received the treatment 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 (SHP647) 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 (SHP647) SC injection, using a prefilled syringe (PFS).

    Arm title
    Ontamalimab 25 mg
    Arm description
    Subjects received 25 milligrams (mg) of ontamalimab (SHP647) 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 (SHP647) SC injection, using a PFS.

    Arm title
    Ontamalimab 75 mg
    Arm description
    Subjects received 75 mg of ontamalimab (SHP647) 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 (SHP647) SC injection, using a PFS.

    Number of subjects in period 1
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Started
    76
    151
    151
    Completed
    66
    136
    138
    Not completed
    10
    15
    13
         Protocol Deviation
    -
    3
    2
         Physician decision
    1
    -
    -
         Lack of efficacy
    2
    -
    1
         Adverse event, non-fatal
    3
    8
    5
         Consent withdrawn by subject
    4
    2
    4
         Lost to follow-up
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to ontamalimab (SHP647) 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 (SHP647) 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 (SHP647) 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
    76 151 151
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    38.3 ± 13.33 39.4 ± 13.90 41.2 ± 14.75 -
    Sex: Female, Male
    Units: Subjects
        Female
    33 56 62 151
        Male
    43 95 89 227
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    2 2 3 7
        Not Hispanic or Latino
    74 149 146 369
        Unknown or Not Reported
    0 0 2 2
    Race, Customized
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian: Japanese
    1 6 8 15
        Asian: Korean
    0 0 0 0
        Asian: Other
    0 4 1 5
        Black or African American
    1 2 5 8
        White
    72 134 136 342
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Multiple
    2 4 1 7
        Other
    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 (SHP647) 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 (SHP647) 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 (SHP647) 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 at Week 12

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    End point title
    Number of Subjects With Remission 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 consisted of 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); PGA (0-3). Full analysis set (FAS) consisted of all subjects in the randomized set who had received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    12
    28
    45
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.617 [1]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - P-value was based on Cochran-Mantel-Haenszel (CMH) 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
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.018
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - P-value was based on CMH 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 investigational product.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    16
    42
    62
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.253 [3]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - P-value was based on CMH 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
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002 [4]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - P-value was based on CMH 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 (SF) 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. Rectal bleeding is 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 is 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. FAS consisted of all subjects in the randomized set who had received at least 1 dose of investigational product.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    29
    61
    76
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.764 [5]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [5] - P-value was based on CMH 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
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.08 [6]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - P-value was based on CMH 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 investigational product.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    34
    76
    99
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.44 [7]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [7] - P-value was based on CMH 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
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002 [8]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [8] - P-value was based on CMH 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. FAS consisted of all subjects in the randomized set who had received at least 1 dose of investigational product.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    13
    35
    51
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Ontamalimab 25 mg
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.286 [9]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [9] - P-value was based on CMH 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
    227
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.005 [10]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [10] - P-value was based on CMH 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. 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 investigational product.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    11
    25
    40
    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 investigational product.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    32
    78
    97
    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 investigational product.
    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
    76
    151
    151
    Units: Subjects
        At Week 4
    13
    38
    47
        At Week 8
    23
    57
    62
        At Week 12
    22
    60
    78
    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
    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. 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. FAS consisted of all subjects in the randomized set who had received at least 1 dose of investigational product.
    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
    76
    151
    151
    Units: Subjects
        At Week 4
    15
    34
    38
        At Week 8
    23
    57
    60
    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 investigational product.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    9
    10
    22
    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 Weeks 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 Weeks 4, 8, and 12
    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. FAS consisted of all subjects in the randomized set who had received at least 1 dose of investigational product.
    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
    76
    151
    151
    Units: Subjects
        At Week 4
    7
    20
    15
        At Week 8
    12
    24
    29
        At Week 12
    11
    37
    39
    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 investigational product.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
    7
    6
    18
    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 daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the 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: 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
    68
    136
    141
    Units: Score on a Scale
        least squares mean (standard error)
    -1.69 ± 0.271
    -2.15 ± 0.196
    -2.14 ± 0.194
    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 daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the 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
    68
    136
    141
    Units: Score on a Scale
        least squares mean (standard error)
    -2.90 ± 0.378
    -3.08 ± 0.273
    -3.50 ± 0.272
    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

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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
    End point description
    PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the 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 to 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
    68
    136
    141
    Units: Score on a Scale
        least squares mean (standard error)
    -2.38 ± 0.341
    -2.60 ± 0.246
    -2.84 ± 0.245
    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 daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the 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 to 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
    68
    136
    141
    Units: Score on a Scale
        least squares mean (standard error)
    -2.27 ± 0.363
    -2.78 ± 0.262
    -2.86 ± 0.260
    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 daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the 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 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. 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
    68
    136
    141
    Units: Score on a Scale
        least squares mean (standard error)
    -2.85 ± 0.337
    -3.50 ± 0.242
    -3.50 ± 0.240
    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 investigational product. 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
    68
    136
    141
    Units: Score on a Scale
        least squares mean (standard error)
    -1.92 ± 0.234
    -2.15 ± 0.169
    0.169 ± 0.168
    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 domains: 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. 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 investigational product. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint and n=number of subjects signifies subjects who were evaluable at given categories.
    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
    72
    147
    144
    Units: Score on a Scale
    least squares mean (standard error)
        IBDQ BFDS: Change at Week 8 (n=72,147,144)
    11.32 ± 1.414
    16.27 ± 1.006
    15.70 ± 1.026
        IBDQ BFDS: Change at Week 12 (n=69,141,142)
    12.89 ± 1.568
    16.19 ± 1.114
    17.18 ± 1.127
        IBDQ ESDS: Change at Week 8 (n=72,147,144)
    9.15 ± 1.596
    14.54 ± 1.136
    14.46 ± 1.157
        IBDQ ESDS: Change at Week 12 (n=69,141,142)
    10.10 ± 1.732
    14.62 ± 1.230
    16.01 ± 1.243
        IBDQ SSDS: Change at Week 8 (n=72,147,144)
    4.05 ± 0.681
    6.47 ± 0.485
    6.03 ± 0.494
        IBDQ SSDS: Change at Week 12 (n=69,141,142)
    4.44 ± 0.735
    6.19 ± 0.522
    6.72 ± 0.528
        IBDQ SFDS: Change at Week 8 (n=72,147,144)
    4.89 ± 0.806
    7.59 ± 0.576
    7.14 ± 0.586
        IBDQ SFDS: Change at Week 12 (n=69,141,142)
    6.11 ± 0.862
    7.95 ± 0.615
    8.24 ± 0.621
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in IBDQ Total Scores at Weeks 8 and 12
    End point description
    IBDQ was a psychometrically validated PRO instrument for measuring disease-specific HRQL in subjects with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 domains: 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. Total IBDQ score ranged from 32 to 224. For 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. Analysis was performed using FAS. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint and n=number of subjects signifies subjects who were evaluable at given categories.
    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
    72
    147
    144
    Units: Score on a Scale
    least squares mean (standard error)
        Change at Week 8 (n=72,147,144)
    29.55 ± 4.205
    44.97 ± 2.999
    43.36 ± 3.053
        Change at Week 12 (n=69,141,142)
    33.52 ± 4.595
    45.00 ± 3.269
    48.12 ± 3.305
    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
    69
    141
    142
    Units: Score on a Scale
    least squares mean (standard error)
        Physical Component Summary: Change at Week 12
    4.92 ± 0.848
    6.76 ± 0.604
    6.54 ± 0.610
        Mental Component Summary: Change at Week 12
    3.89 ± 1.113
    5.83 ± 0.792
    6.37 ± 0.799
    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. The 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
    69
    141
    142
    Units: Score on a Scale
    least squares mean (standard error)
        Physical Functioning: Change at Week 12
    4.89 ± 0.766
    5.41 ± 0.545
    4.32 ± 0.550
        Role-Physical: Change at Week 12
    3.99 ± 1.059
    6.97 ± 0.754
    7.65 ± 0.762
        Bodily Pain: Change at Week 12
    6.28 ± 1.132
    8.83 ± 0.805
    8.50 ± 0.814
        General Health: Change at Week 12
    3.36 ± 0.976
    4.78 ± 0.693
    5.36 ± 0.699
        Vitality: Change at Week 12
    4.96 ± 1.202
    8.08 ± 0.857
    8.69 ± 0.865
        Social Functioning: Change at Week 12
    6.07 ± 1.160
    7.80 ± 0.827
    8.56 ± 0.833
        Role-Emotional: Change at Week 12
    3.25 ± 1.082
    4.55 ± 0.765
    4.04 ± 0.772
        Mental Health: Change at Week 12
    3.93 ± 1.096
    5.81 ± 0.781
    6.59 ± 0.786
    No statistical analyses for this end point

    Secondary: Number of Subjects Based on In-patient Hospitalization

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    End point title
    Number of Subjects Based on In-patient Hospitalization
    End point description
    Number of subjects based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and who had undergone gastrointestinal related procedures during the entire study period was reported. FAS consisted of all subjects in the randomized set who had received at least 1 dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    76
    151
    151
    Units: Subjects
        All-Cause Hospitalization
    3
    8
    5
        Gastrointestinal Related
    0
    5
    2
        Other Illness/Problem
    3
    3
    3
        Undergo Gastrointestinal Related Procedures
    0
    5
    2
    No statistical analyses for this end point

    Secondary: Median Duration of Total In-patient Days

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    End point title
    Median Duration of Total In-patient Days
    End point description
    In-patient 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 investigational product. Here, number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    3
    8
    5
    Units: Days
        median (full range (min-max))
    5.0 (3 to 7)
    7.0 (1 to 13)
    4.0 (3 to 8)
    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 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 title
    Ontamalimab 25 mg
    Reporting group description
    Subjects received 25 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 75 mg Ontamalimab 25 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 76 (6.58%)
    8 / 151 (5.30%)
    10 / 151 (6.62%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 151 (0.00%)
    0 / 151 (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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (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
    Prostate cancer
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (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
    T-cell lymphoma
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (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
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 151 (0.00%)
    0 / 151 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 76 (2.63%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 151 (0.00%)
    0 / 151 (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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 76 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         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
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    6 / 151 (3.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (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
    Musculoskeletal and connective tissue disorders
    Myopathy
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Undifferentiated connective tissue disease
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (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
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 76 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 151 (0.00%)
    0 / 151 (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
    Nasopharyngitis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (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 75 mg Ontamalimab 25 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 76 (13.16%)
    6 / 151 (3.97%)
    20 / 151 (13.25%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 76 (9.21%)
    1 / 151 (0.66%)
    10 / 151 (6.62%)
         occurrences all number
    7
    1
    11
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    4 / 76 (5.26%)
    2 / 151 (1.32%)
    3 / 151 (1.99%)
         occurrences all number
    4
    2
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 76 (2.63%)
    3 / 151 (1.99%)
    10 / 151 (6.62%)
         occurrences all number
    2
    3
    10

    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: - Added information to provide appropriate guidance regarding laboratory testing for Clostridium difficile infection. - 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: - Added text to clarify that infectious etiology must be evaluated when a subject experienced an increase in gastrointestinal (GI) symptoms. - Added text to address Food and Drug administration (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 early as per the sponsor decision to discontinue the ontamalimab clinical trial development program for inflammatory bowel diseases (IBD) for reasons unrelated to safety and efficacy.
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