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    Clinical Trial Results:
    A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2014-005217-24
    Trial protocol
    		 HU   CZ   SK   BG   GB   AT   DE   BE   NL   LV   SE   ES   IE   IS   HR  
    Global end of trial date
    22 Nov 2016

    Results information
    Results version number
    		 v1
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-326-1100
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02520284
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Clinical Trials Registry- India: CTRI/2016/09/007304
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd., ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd., ClinicalTrialDisclosures@gilead.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
    22 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the efficacy, safety, and tolerability of andecaliximab (GS-5745). This study was to consist of a sequential 2-part induction study (Cohort 1, Part A and Part B), a maintenance study (Cohort 2), and an optional extended treatment phase for participants who completed 52 weeks of treatment.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 61
    Country: Number of subjects enrolled
    Russian Federation: 10
    Country: Number of subjects enrolled
    Ukraine: 9
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Romania: 7
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    New Zealand: 4
    Country: Number of subjects enrolled
    South Africa: 2
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Taiwan: 1
    Worldwide total number of subjects
    165
    EEA total number of subjects
    59
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    152
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in South Africa, Europe, North America, and Asia Pacific. The first participant was screened on 15 September 2015. The last study visit occurred on 22 November 2017.

    Pre-assignment
    Screening details
    		 241 participants were screened.

    Period 1
    Period 1 title
    Blinded Induction Phase
    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
    		 Andecaliximab Q2W
    Arm description
    		 Andecaliximab 150 mg subcutaneous (SC) injection once every 2 weeks (Q2W) for a total of 4 doses alternating with matching placebo every 2 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    GS-5745
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg SC injection once every 2 weeks for a total of 4 doses

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo SC injection once every 2 weeks

    Arm title
    		 Andecaliximab QW
    Arm description
    		 Andecaliximab 150 mg subcutaneous injection once weekly (QW) for a total of 8 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    GS-5745
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg SC injection once every week for a total of 8 doses

    Arm title
    		 Placebo
    Arm description
    		 Placebo SC injection once every week
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo SC injection once every week

    Number of subjects in period 1
    		Andecaliximab Q2W Andecaliximab QW Placebo
    Started
    54
    56
    55
    Completed
    52
    52
    53
    Not completed
    2
    4
    2
         Withdrew Consent
    1
    1
    1
         Adverse event, non-fatal
    1
    3
    -
         Study Terminated by Sponsor
    -
    -
    1
    Period 2
    Period 2 title
    Blinded Maintenance Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Andecaliximab Q2W
    Arm description
    		 Andecaliximab 150 mg SC injection once every 2 weeks for a total of 4 doses alternating with matching placebo every 2 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    GS-5745
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg SC injection once every 2 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo SC injection once every 2 weeks

    Arm title
    		 Andecaliximab QW
    Arm description
    		 Andecaliximab 150 mg subcutaneous injection once weekly for a total of 8 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    GS-5745
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg SC injection once every week for a total of 8 doses

    Arm title
    		 Placebo
    Arm description
    		 Placebo SC injection weekly
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo SC injection once every week

    Number of subjects in period 2
    		Andecaliximab Q2W Andecaliximab QW Placebo
    Started
    20
    16
    18
    Completed
    0
    0
    0
    Not completed
    20
    16
    18
         Adverse event, non-fatal
    1
    1
    -
         Disease Worsening
    2
    2
    3
         Study Terminated by Sponsor
    17
    11
    15
         Disposition Error
    -
    2
    -
    Period 3
    Period 3 title
    Open-Label Maintenance Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Open-Label Andecaliximab QW from Andecaliximab Q2W
    Arm description
    		 Participants from the Andecaliximab Q2W group in the induction period, who did not achieve EBS clinical remission and/or MCS response based on Week 8 assessments (Week 8 nonresponders) received open-label andecaliximab 150 mg weekly for up to 51 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    GS-5745
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg SC injection once every week for up to 51 weeks

    Arm title
    		 Open-Label Andecaliximab QW from Andecaliximab QW
    Arm description
    		 Participants from the Andecaliximab QW group in the induction period, who did not achieve EBS clinical remission and/or MCS response based on Week 8 assessments (Week 8 nonresponders) received open-label andecaliximab 150 mg weekly for up to 51 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    GS-5745
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg SC injection once a week for up to 51 weeks

    Arm title
    		 Open-Label Andecaliximab QW from Placebo
    Arm description
    		 Participants from the Placebo group in the induction period, who did not achieve EBS clinical remission and/or MCS response based on Week 8 assessments (Week 8 nonresponders) received open-label andecaliximab 150 mg weekly for up to 51 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    GS-5745
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg SC injection once every week for up to 51 weeks

    Number of subjects in period 3
    		Open-Label Andecaliximab QW from Andecaliximab Q2W Open-Label Andecaliximab QW from Andecaliximab QW Open-Label Andecaliximab QW from Placebo
    Started
    20
    35
    34
    Completed
    0
    0
    0
    Not completed
    32
    35
    34
         Withdrew Consent
    3
    4
    2
         Adverse event, non-fatal
    2
    1
    3
         Investigator's Discretion
    2
    1
    1
         Study Terminated by Sponsor
    25
    29
    28
    Joined
    12
    0
    0
         ebs
    12
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Andecaliximab Q2W
    Reporting group description
    		 Andecaliximab 150 mg subcutaneous (SC) injection once every 2 weeks (Q2W) for a total of 4 doses alternating with matching placebo every 2 weeks

    Reporting group title
    Andecaliximab QW
    Reporting group description
    		 Andecaliximab 150 mg subcutaneous injection once weekly (QW) for a total of 8 doses

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo SC injection once every week

    Reporting group values
    		 Andecaliximab Q2W Andecaliximab QW Placebo Total
    Number of subjects
    		 54 56 55 165
    Age categorical
    Units: Subjects
    Age continuous
    Safety Analysis Set includes all participants who took at least 1 dose of study drug in the Induction Study.
    Units: years
        arithmetic mean (standard deviation)
    		 44 ± 14.1 43 ± 13.2 43 ± 12.8 -
    Gender categorical
    Units: Subjects
        Female
    		 19 18 24 61
        Male
    		 35 38 31 104
    Race
    Units: Subjects
        White
    		 48 48 45 141
        Black
    		 4 3 3 10
        Asian
    		 2 4 4 10
        Native Hawaiian or Pacific
    		 0 0 1 1
        Not Permitted
    		 0 0 1 1
        Other
    		 0 1 1 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 2 2
        Not Hispanic or Latino
    		 54 56 51 161
        Not Permitted
    		 0 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    Andecaliximab Q2W
    Reporting group description
    		 Andecaliximab 150 mg subcutaneous (SC) injection once every 2 weeks (Q2W) for a total of 4 doses alternating with matching placebo every 2 weeks

    Reporting group title
    Andecaliximab QW
    Reporting group description
    		 Andecaliximab 150 mg subcutaneous injection once weekly (QW) for a total of 8 doses

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo SC injection once every week
    Reporting group title
    Andecaliximab Q2W
    Reporting group description
    		 Andecaliximab 150 mg SC injection once every 2 weeks for a total of 4 doses alternating with matching placebo every 2 weeks

    Reporting group title
    Andecaliximab QW
    Reporting group description
    		 Andecaliximab 150 mg subcutaneous injection once weekly for a total of 8 doses

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo SC injection weekly
    Reporting group title
    Open-Label Andecaliximab QW from Andecaliximab Q2W
    Reporting group description
    		 Participants from the Andecaliximab Q2W group in the induction period, who did not achieve EBS clinical remission and/or MCS response based on Week 8 assessments (Week 8 nonresponders) received open-label andecaliximab 150 mg weekly for up to 51 weeks

    Reporting group title
    Open-Label Andecaliximab QW from Andecaliximab QW
    Reporting group description
    		 Participants from the Andecaliximab QW group in the induction period, who did not achieve EBS clinical remission and/or MCS response based on Week 8 assessments (Week 8 nonresponders) received open-label andecaliximab 150 mg weekly for up to 51 weeks.

    Reporting group title
    Open-Label Andecaliximab QW from Placebo
    Reporting group description
    		 Participants from the Placebo group in the induction period, who did not achieve EBS clinical remission and/or MCS response based on Week 8 assessments (Week 8 nonresponders) received open-label andecaliximab 150 mg weekly for up to 51 weeks.

    Primary: For Cohort 1, percentage of participants with endoscopy, rectal bleeding, and stool frequency (EBS) Clinical Remission at Week 8

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    End point title
    		 For Cohort 1, percentage of participants with endoscopy, rectal bleeding, and stool frequency (EBS) Clinical Remission at Week 8 [1]
    End point description
    EBS clinical remission was defined as an endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and at least a one point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Full Analysis Set: all randomized participants who take at least 1 dose of study drug in the Induction Study (Cohort 1).
    End point type
    Primary
    End point timeframe
    Week 8
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to termination of the study, no statistical comparison was performed.
    End point values
    		 Andecaliximab Q2W Andecaliximab QW Placebo
    Number of subjects analysed
    54
    56
    55
    Units: Percentage of participants
        number (confidence interval 95%)
    7.4 (2.1 to 17.9)
    1.8 (0 to 9.6)
    7.3 (2 to 17.6)
    No statistical analyses for this end point

    Secondary: For Cohort 1, percentage of participants with Mayo Clinic Score (MCS) Remission at Week 8

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    End point title
    		 For Cohort 1, percentage of participants with Mayo Clinic Score (MCS) Remission at Week 8
    End point description
    1) Mayo clinic score was composed of subscores from endoscopy, rectal bleeding, stool frequency, and PGA. Mayo clinic score remission was defined as a MCS of ≤ 2 points and no individual subscore > 1 point. 2) Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Andecaliximab Q2W Andecaliximab QW Placebo
    Number of subjects analysed
    54
    56
    55
    Units: Percentage of participants
        number (not applicable)
    7.4
    1.8
    7.3
    No statistical analyses for this end point

    Secondary: For Cohort 1, percentage of participants achieving MCS response at Week 8

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    End point title
    		 For Cohort 1, percentage of participants achieving MCS response at Week 8
    End point description
    1) Mayo clinic score response was defined as a MCS reduction of ≥ 3 points and at least 30% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0 or 1. 2) Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Andecaliximab Q2W Andecaliximab QW Placebo
    Number of subjects analysed
    54
    56
    55
    Units: Percentage of participants
        number (not applicable)
    46.3
    30.4
    30.9
    No statistical analyses for this end point

    Secondary: For Cohort 1, percentage of participants achieving endoscopic remission (endoscopic subscore of 0) at Week 8

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    End point title
    		 For Cohort 1, percentage of participants achieving endoscopic remission (endoscopic subscore of 0) at Week 8
    End point description
    Endoscopic remission was defined as an endoscopic subscore of 0.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Andecaliximab Q2W Andecaliximab QW Placebo
    Number of subjects analysed
    54
    56
    55
    Units: Percentage of participants
        number (not applicable)
    3.7
    0
    5.5
    No statistical analyses for this end point

    Secondary: For Cohort 1, percentage of participants achieving endoscopic response (endoscopic subscore 0 or 1) at Week 8

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    End point title
    		 For Cohort 1, percentage of participants achieving endoscopic response (endoscopic subscore 0 or 1) at Week 8
    End point description
    1) Endoscopic response was defined as an endoscopic subscore of 0 or 1. 2) Full analysis Set
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Andecaliximab Q2W Andecaliximab QW Placebo
    Number of subjects analysed
    54
    56
    55
    Units: Percenage of participants
        number (not applicable)
    18.5
    7.1
    14.5
    No statistical analyses for this end point

    Secondary: For Cohort 1: percentage of participants achieving mucosal healing as determined by the Geboes histologic scoring system at Week 8

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    End point title
    		 For Cohort 1: percentage of participants achieving mucosal healing as determined by the Geboes histologic scoring system at Week 8
    End point description
    1) Mucosal healing was defined as elimination of ulcers/erosion, elimination of crypt destruction, elimination of intraepithelial neutrophils, elimination of lamina propria neutrophils, and reduction in lamina propria chronic inflammatory cells to at most a mild increase. When measured by the Geboes histologic scoring system, it was the selection of the following combined scores of ≤ 3 for Grade 0 (Structural Architectural Change), ≤ 1 for Grade 1 (Chronic Inflammatory Infiltrate), ≤ 3 for Grade 2A (Lamina Propria Eosinophils), and 0 for Grade 2B (Lamina Propria Neutrophils), Grade 3 (Neutrophils in Epithelium), Grade 4 (Crypt Destruction), and Grade 5 (Erosion or Ulceration). 2) Full Analysis Set 3) For calculating the percentage of participants achieving mucosal healing as determined by Geboes histologic scoring system, only participants who did not meet the mucosal healing definition at baseline were included.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Andecaliximab Q2W Andecaliximab QW Placebo
    Number of subjects analysed
    50
    51
    50
    Units: Percentage of participants
        number (not applicable)
    18
    13.7
    22
    No statistical analyses for this end point

    Secondary: For Cohort 1: percentage of participants achieving remission as defined by MCS remission (alternative definition) at Week 8

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    End point title
    		 For Cohort 1: percentage of participants achieving remission as defined by MCS remission (alternative definition) at Week 8
    End point description
    1) Mayo clinic score remission (alternative definition) was defined as a rectal bleeding, stool frequency, and PGA subscore of 0, and an endoscopic subscore of 0 or 1 for an overall MCS of ≤ 1. 2) Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Andecaliximab Q2W Andecaliximab QW Placebo
    Number of subjects analysed
    54
    56
    55
    Units: Percentage participants
        number (not applicable)
    1.9
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Induction Period: First dose of andecaliximab to Week 8; Double-Blind (DB) Period: First dose of andecaliximab to Week 52 plus 30 days; Open-Label (OL) Period: First dose of open-label andecaliximab to Week 52 plus 30 days
    Adverse event reporting additional description
    Safety data in general was summarized by the following analysis periods by treatment group: 1. Induction Period (All Subjects) 2. DB Treatment Period (Wk 8 Responders; included safety data collected for these subjects between Week 0 and Wk 8 in the induction period, as well as the DB maintenance phase) 3. OL Maintenance Period (Wk 8 Nonresponders)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Induction Andecaliximab Q2W
    Reporting group description
    		 1) Andecaliximab 150 mg SC injection once every 2 weeks for a total of 4 doses 2) Adverse events (AE) reported in this group occurred during the Induction with Additional Dose Period (Baseline to Week 8): any AEs with an onset date on or after the induction study start date and no later than 30 days after permanent discontinuation of study drug if discontinued in this period, any AEs with an onset date on or after the induction study start date and before Week 9 dosing date and no later than 30 days after the Week 8 additional dosing date, and any AEs leading to premature discontinuation.

    Reporting group title
    Induction Andecaliximab QW
    Reporting group description
    		 1) Andecaliximab 150 mg SC injection once every week for a total of 8 doses 2) Adverse events reported in this group occurred during the Induction with Additional Dose Period (Baseline to Week 8): any AEs with an onset date on or after the induction study start date and no later than 30 days after permanent discontinuation of study drug if discontinued in this period, any AEs with an onset date on or after the induction study start date and before Week 9 dosing date and no later than 30 days after the Week 8 additional dosing date, and any AEs leading to premature discontinuation.

    Reporting group title
    Induction Placebo
    Reporting group description
    		 1) Placebo SC injection once every week up to 8 weeks 2) Adverse events (AE) reported in this group occurred during the Induction with Additional Dose Period (Baseline to Week 8): any AEs with an onset date on or after the induction study start date and no later than 30 days after permanent discontinuation of study drug if discontinued in this period, any AEs with an onset date on or after the induction study start date and before Week 9 dosing date and no later than 30 days after the Week 8 additional dosing date, and any AEs leading to premature discontinuation.

    Reporting group title
    Double-Blind Maintenance Andecaliximab Q2W
    Reporting group description
    		 1) Andecaliximab 150 mg SC injection once every 2 weeks for up to 52 weeks 2) Adverse events reported in this group occurred during the Induction or Double-Blind Periods (Baseline to Week 52 plus 30 days): any AEs with an onset date on or after the double-blinded study drug start date and no later than EITHER 30 days after permanent discontinuation of double-blinded study drug if not switched to OL treatment, OR the first dose date of OL dose if switched.

    Reporting group title
    Double-Blind Maintenance Andecaliximab QW
    Reporting group description
    		 1) Andecaliximab 150 mg subcutaneous injection once every week for up to 52 weeks 2) Adverse events reported in this group occurred during the Induction or Double-Blind Periods (Baseline to Week 52 plus 30 days): any AEs with an onset date on or after the double-blinded study drug start date and no later than EITHER 30 days after permanent discontinuation of double-blinded study drug if not switched to OL treatment, OR the first dose date of OL dose if switched.

    Reporting group title
    Double-Blind Maintenance Placebo
    Reporting group description
    		 1) Placebo SC injection once every week for up to 52 weeks 2) Adverse events reported in this group occurred during the Induction or Double-Blind Periods (Baseline to Week 52 plus 30 days): any AEs with an onset date on or after the double-blinded study drug start date and no later than EITHER 30 days after permanent discontinuation of double-blinded study drug if not switched to OL treatment, OR the first dose date of OL dose if switched

    Reporting group title
    Open-Label Andecaliximab QW from Andecaliximab Q2W
    Reporting group description
    		 1) Participants from the Andecaliximab Q2W group in the induction period, who switched to open-label treatment after Week 8 assessment and received open-label andecaliximab 150 mg weekly up to 51 weeks. 2) Adverse events reported in this group occurred during the Open-Label Period (Study drug start during open-label to Week 52 plus 30 days): any AEs with an onset date on or after the open-label study drug start date and no later than 30 days after permanent discontinuation of open-label study drug.

    Reporting group title
    Open-Label Andecaliximab QW from Andecaliximab QW
    Reporting group description
    		 1) Participants from the Andecaliximab QW group in the induction period, who switched to open-label treatment after Week 8 assessment and received open-label andecaliximab 150 mg weekly up to 51 weeks. 2) Adverse events for Open-Label Period (Study drug start during open-label to Week 52 plus 30 days) were any AEs with an onset date on or after the open-label study drug start date and no later than 30 days after permanent discontinuation of open-label study drug.

    Reporting group title
    Open-Label Andecaliximab QW from Placebo
    Reporting group description
    		 1) Participants from the placebo group in the induction period, who switched to open-label treatment after Week 8 assessment and received open-label andecaliximab 150 mg weekly up to 51 weeks. 2) Adverse events for Open-Label Period (Study drug start during open-label to Week 52 plus 30 days) were any AEs with an onset date on or after the open-label study drug start date and no later than 30 days after permanent discontinuation of open-label study drug.

    Serious adverse events
    		 Induction Andecaliximab Q2W Induction Andecaliximab QW Induction Placebo Double-Blind Maintenance Andecaliximab Q2W Double-Blind Maintenance Andecaliximab QW Double-Blind Maintenance Placebo Open-Label Andecaliximab QW from Andecaliximab Q2W Open-Label Andecaliximab QW from Andecaliximab QW Open-Label Andecaliximab QW from Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
    1 / 55 (1.82%)
    1 / 20 (5.00%)
    2 / 16 (12.50%)
    1 / 18 (5.56%)
    1 / 32 (3.13%)
    3 / 35 (8.57%)
    2 / 34 (5.88%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 32 (3.13%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary dilatation
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Induction Andecaliximab Q2W Induction Andecaliximab QW Induction Placebo Double-Blind Maintenance Andecaliximab Q2W Double-Blind Maintenance Andecaliximab QW Double-Blind Maintenance Placebo Open-Label Andecaliximab QW from Andecaliximab Q2W Open-Label Andecaliximab QW from Andecaliximab QW Open-Label Andecaliximab QW from Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 54 (44.44%)
    31 / 56 (55.36%)
    26 / 55 (47.27%)
    12 / 20 (60.00%)
    12 / 16 (75.00%)
    13 / 18 (72.22%)
    9 / 32 (28.13%)
    6 / 35 (17.14%)
    12 / 34 (35.29%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    1 / 20 (5.00%)
    1 / 16 (6.25%)
    2 / 18 (11.11%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    3
    1
    1
    1
    2
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    0
    0
    0
    Injection site bruising
         subjects affected / exposed
    1 / 54 (1.85%)
    4 / 56 (7.14%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    1
    0
    0
    Injection site erythema
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    5
    0
    0
    Injection site hypersensitivity
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 54 (1.85%)
    4 / 56 (7.14%)
    1 / 55 (1.82%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    4
    1
    1
    0
    1
    0
    0
    0
    Thirst
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Menstrual disorder
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Uterine prolapse
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 56 (5.36%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    2 / 16 (12.50%)
    0 / 18 (0.00%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    3
    1
    0
    2
    0
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    0
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    2 / 55 (3.64%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    2 / 16 (12.50%)
    0 / 18 (0.00%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    1
    0
    0
    Iron deficiency
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Injection related reaction
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    2 / 55 (3.64%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    0
    0
    Radius fracture
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    2 / 18 (11.11%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    2
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 54 (3.70%)
    4 / 56 (7.14%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    2 / 16 (12.50%)
    1 / 18 (5.56%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    4
    1
    0
    2
    1
    1
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Polyneuropathy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 54 (7.41%)
    4 / 56 (7.14%)
    2 / 55 (3.64%)
    3 / 20 (15.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    1 / 35 (2.86%)
    3 / 34 (8.82%)
         occurrences all number
    4
    4
    2
    3
    1
    0
    0
    1
    3
    Thrombocytosis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    2
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 56 (3.57%)
    5 / 55 (9.09%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    5
    1
    0
    1
    0
    0
    1
    Colitis ulcerative
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 56 (5.36%)
    1 / 55 (1.82%)
    2 / 20 (10.00%)
    1 / 16 (6.25%)
    4 / 18 (22.22%)
    1 / 32 (3.13%)
    1 / 35 (2.86%)
    3 / 34 (8.82%)
         occurrences all number
    2
    3
    1
    2
    1
    4
    1
    1
    4
    Dyschezia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 20 (5.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    1
    1
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Mouth ulceration
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 56 (3.57%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    2 / 35 (5.71%)
    0 / 34 (0.00%)
         occurrences all number
    2
    3
    3
    0
    0
    0
    0
    2
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    2 / 16 (12.50%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    0
    0
    0
    Alopecia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    0
    0
    Erythema nodosum
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Night sweats
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    0
    0
    0
    Onychoclasis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    1
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    1 / 20 (5.00%)
    3 / 16 (18.75%)
    3 / 18 (16.67%)
    0 / 32 (0.00%)
    2 / 35 (5.71%)
    1 / 34 (2.94%)
         occurrences all number
    1
    3
    3
    1
    3
    3
    0
    2
    1
    Back pain
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 56 (5.36%)
    2 / 55 (3.64%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    3
    2
    0
    1
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    2 / 55 (3.64%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    2 / 18 (11.11%)
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    2
    1
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 56 (3.57%)
    2 / 55 (3.64%)
    0 / 20 (0.00%)
    2 / 16 (12.50%)
    2 / 18 (11.11%)
    1 / 32 (3.13%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences all number
    2
    3
    2
    0
    3
    2
    1
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 56 (5.36%)
    0 / 55 (0.00%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
         occurrences all number
    0
    3
    0
    0
    1
    0
    0
    3
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 56 (3.57%)
    0 / 55 (0.00%)
    1 / 20 (5.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    0
    1
    1
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Fluid retention
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 56 (7.14%)
    1 / 55 (1.82%)
    0 / 20 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    4
    1
    0
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 May 2015
    1. Clarified that physician’s global assessment is measured at baseline and part of eligibility criteria 2. Updated immunomodulator and vedolizumab minimum duration of treatment prior therapy as part of the eligibility criteria 3. Updated steroid tapering to include a reduction range from 2.5 mg/week to 5 mg/week 4. Clarified that albumin is analyzed as part of the chemistry panel
    27 Oct 2015
    1. Added evaluation of sustained MCS clinical remission, and definition of sustained MCS clinical remission, under secondary objectives and endpoints 2. Added evaluation of corticosteroid-free EBS clinical remission for at least 24 weeks prior to Week 52 under secondary objectives and endpoints 3. Added a 70% TNF-α antagonist treatment cap to Cohort 2 open-label induction phase enrollment and removed cap from Cohort 2 blinded maintenance phase randomization 4. Clarified golimumab dose/exposure in inclusion criteria 5. Added treatment with tacrolimus and apheresis therapy to exclusion criteria and prohibited concomitant medication 6. Specified that compliance phone call for stool frequency and rectal bleeding documentation should occur approximately 4 days after the screening visit 7. Clarified that if a colonoscopy was performed at screening, a flexible sigmoidoscopy was not required 8. Clarified that 3 biopsy samples must be collected at screening 9. Added instruction to remind subjects to complete documentation of dosing log for subjects dosing at home 10. Removed lack of efficacy from the list of AEs/serious adverse events (SAEs) to be collected 11. Added AEs arising from occupational exposure to special situation reporting requirements 12. Added collection of microbiome sample to study procedures table 13. Applied stopping rules and follow-up visit requirement for disease worsening to open-label maintenance phase 14. Clarified that study medication may be discontinued if a subject experiences exclusionary medical conditions
    29 Feb 2016
    1. Added an extended treatment phase for subjects completing Cohort 1 and Cohort 2 and described timing of study visits, procedures, and analyses specific to this phase 2. Clarified randomization stratification 3. Added methotrexate as an approved immunomodulator and concomitant UC medication in the inclusion criteria 4. Clarified screening of new subjects once the 70% cap on prior TNF-α antagonist therapy was met 5. Clarified inclusion criteria to specify that females were to be nonpregnant and nonlactating 6. Clarified collection time points for the optional PK substudy 7. Clarified screening visit assessments
    13 Jun 2016
    1. Clarified disease worsening discontinuation criteria as it related to subject discontinuation and follow-up requirements during the open-label maintenance or extended treatment phase 2.Updated the name and contact information for the Gilead study director and medical monitor 3. Revised inclusion criteria to specify subject requirements for prior immunomodulator, TNF-α agonist, or vedolizumab therapy in order to clarify criteria for an inadequate clinical response to these therapies 4. Revised exclusion criteria to exclude subjects with known hypersensitivity to any components of the investigational medicinal product 5. Made exclusionary laboratory parameters for liver panel values more restrictive (> 2 times the upper limit of the normal range [ULN]) 6. Revised exclusion criteria to clarify temporal restriction for prior treatment with tacrolimus and apheresis 7. Clarified that subjects requiring dose increases to allowed UC medications during the induction phase would be discontinued from the study 8. Defined mucosal healing for the purposes of study evaluation 9. Clarified UC medications allowed during the open-label maintenance and extended treatment phases of the study 10. Specified that investigational drugs for the treatment of UC were prohibited during the study 11. Specified clinical laboratory analytes to be evaluated and antibody/antigen tests to be conducted

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 Sep 2016
    After the first 150 subjects completed the 8-week induction phase, the data monitoring committee (DMC) for this Study conducted a protocol-specified interim analysis. After review, the DMC recommended that the study be terminated due to meeting the prespecified futility and efficacy criteria. Effective 21 September 2016, Study GS-US-326-1100 was terminated. Part B of Cohort 1 and Cohort 2 were not enrolled.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The DMC recommended that the study be terminated due to meeting the prespecified futility & efficacy criteria. Due to termination of the study, no formal statistical testing was planned for the final analysis.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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