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    Clinical Trial Results:
    A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease

    Summary
    EudraCT number
    		 2015-001249-10
    Trial protocol
    		 HU   DE   CZ   ES   GB   IS   IT  
    Global end of trial date
    22 Dec 2016

    Results information
    Results version number
    		 v3(current)
    This version publication date
    18 May 2019
    First version publication date
    19 Nov 2017
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Adding text to “Limitations and Caveats” section

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-395-1663
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02405442
    WHO universal trial number (UTN)
    		 -
    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 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were as follows: 1) To evaluate the efficacy of an 8-week induction regimen of andecaliximab (formerly GS-5745) to induce a clinical response, defined as a stool frequency and abdominal pain composite (PRO2) score ≤ 8 at Week 8 2) To evaluate the efficacy of an 8-week induction regimen of andecaliximab to induce an endoscopic response, defined as a reduction in the Simple Endoscopic Score for Crohn’s Disease (SES-CD) of ≥ 50% from baseline at Week 8 The study consisted of a Blinded Treatment Period of 8 weeks followed by an Open-Label Extension. Participants who completed the Blinded Treatment Period were eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who completed Week 52 assessments were eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.
    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
    30 Apr 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
    Australia: 9
    Country: Number of subjects enrolled
    New Zealand: 5
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    United States: 104
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Hungary: 5
    Worldwide total number of subjects
    187
    EEA total number of subjects
    62
    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)
    179
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America, Europe, South Africa, and Asia Pacific. The first participant was screened on 30 April 2015. The last study visit occurred on 22 December 2016.

    Pre-assignment
    Screening details
    		 315 participants were screened.

    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
    		 Andecaliximab 150 mg every 2 weeks
    Arm description
    		 • Double-blind Phase: 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6; 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7 • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    Other name
    GS-5745
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    • Double-blind Phase: 1 single-use PFS of andecaliximab 150 mg every 2 weeks for 8 weeks • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Double-blind Phase: 1 single-use PFS of placebo coadministered with andicaliximab at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo administered at Weeks 1, 3, 5, and 7

    Arm title
    		 Andecaliximab 150 mg weekly
    Arm description
    		 • Double-blind Phase: 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    Other name
    GS-5745
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    • Double-blind Phase: 1 single-use PFS of andecaliximab 150 mg weekly for 8 weeks • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Double-blind Phase: 1 single-use PFS of placebo administered weekly for 8 weeks

    Arm title
    		 Andecaliximab 300 mg weekly
    Arm description
    		 • Double-blind Phase: 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    Other name
    GS-5745
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    • Double-blind Phase: 2 single-use PFS of andecaliximab 150 mg weekly • Open-label and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Arm title
    		 Placebo Group
    Arm description
    		 • Double-blind Phase: 2 single-use PFS of placebo coadministered weekly for 8 weeks • Open-label and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Double-blind Phase: 2 single-use PFS of placebo administered weekly for 8 weeks

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    Other name
    GS-5745
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg weekly

    Number of subjects in period 1
    		Andecaliximab 150 mg every 2 weeks Andecaliximab 150 mg weekly Andecaliximab 300 mg weekly Placebo Group
    Started
    53
    53
    53
    28
    Completed
    0
    0
    0
    0
    Not completed
    53
    53
    53
    28
         Study terminated by sponsor
    31
    31
    31
    16
         Adverse event
    5
    2
    6
    5
         Study disease-related symptoms
    1
    2
    3
    2
         Investigator's discretion
    15
    13
    10
    3
         Withdrew consent
    1
    3
    3
    1
         Lost to follow-up
    -
    1
    -
    -
         Lack of efficacy
    -
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Andecaliximab 150 mg every 2 weeks
    Reporting group description
    		 • Double-blind Phase: 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6; 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7 • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Reporting group title
    Andecaliximab 150 mg weekly
    Reporting group description
    		 • Double-blind Phase: 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Reporting group title
    Andecaliximab 300 mg weekly
    Reporting group description
    		 • Double-blind Phase: 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Reporting group title
    Placebo Group
    Reporting group description
    		 • Double-blind Phase: 2 single-use PFS of placebo coadministered weekly for 8 weeks • Open-label and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Reporting group values
    		 Andecaliximab 150 mg every 2 weeks Andecaliximab 150 mg weekly Andecaliximab 300 mg weekly Placebo Group Total
    Number of subjects
    		 53 53 53 28 187
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38 ( 12.8 ) 39 ( 13.5 ) 42 ( 11.7 ) 38 ( 13.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 28 22 15 90
        Male
    		 28 25 31 13 97
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 1 1 0 1 3
        Black or African American
    		 3 4 3 1 11
        Native Hawaiian or Pacific Islander
    		 0 0 0 0 0
        White
    		 48 42 48 22 160
        Other
    		 1 0 1 3 5
        Not Permitted
    		 0 6 1 1 8
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 1 5 1 8
        Not Hispanic or Latino
    		 52 46 47 26 171
        Not Permitted
    		 0 6 1 1 8

    End points

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    End points reporting groups
    Reporting group title
    Andecaliximab 150 mg every 2 weeks
    Reporting group description
    		 • Double-blind Phase: 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6; 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7 • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Reporting group title
    Andecaliximab 150 mg weekly
    Reporting group description
    		 • Double-blind Phase: 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Reporting group title
    Andecaliximab 300 mg weekly
    Reporting group description
    		 • Double-blind Phase: 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks • Open-label Phase and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Reporting group title
    Placebo Group
    Reporting group description
    		 • Double-blind Phase: 2 single-use PFS of placebo coadministered weekly for 8 weeks • Open-label and Extended Treatment Phase: 1 single-use PFS of andecaliximab 150 mg administered weekly

    Primary: Percentage of Participants Achieving Clinical Response (PRO2 score ≤ 8) at Week 8 of the Double-blind Phase

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    End point title
    		 Percentage of Participants Achieving Clinical Response (PRO2 score ≤ 8) at Week 8 of the Double-blind Phase [1]
    End point description
    1) Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. 2) Full Analysis Set: all randomized participants who received at least 1 dose of study drug. 3) Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first open-label dose date. 4) Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.
    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: No hypothesis testing was performed for the primary efficacy endpoints.
    End point values
    		 Andecaliximab 150 mg every 2 weeks Andecaliximab 150 mg weekly Andecaliximab 300 mg weekly Placebo Group
    Number of subjects analysed
    53
    53
    53
    28
    Units: Percentage of Participants
        number (confidence interval 95%)
    17.0 (8.1 to 29.8)
    13.2 (5.5 to 25.3)
    11.3 (4.3 to 23.0)
    14.3 (4.0 to 32.7)
    No statistical analyses for this end point

    Primary: Percentage of Participants Achieving Endoscopic Response (≥ 50% reduction from baseline SES-CD) at Week 8 of the Double-blind Phase

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    End point title
    		 Percentage of Participants Achieving Endoscopic Response (≥ 50% reduction from baseline SES-CD) at Week 8 of the Double-blind Phase [2]
    End point description
    1) Endoscopic response was defined as ≥ 50% reduction from baseline Simple Endoscopic Score for Crohn’s Disease (SES-CD) at Week 8. 2) Participants in the Full Analysis Set were analyzed. 3) Week 8 refers to the analysis window of day 43 to day 70 and prior to the first Open-Label dose date. 4) Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response
    End point type
    Primary
    End point timeframe
    Week 8
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No hypothesis testing was performed for the primary efficacy endpoints.
    End point values
    		 Andecaliximab 150 mg every 2 weeks Andecaliximab 150 mg weekly Andecaliximab 300 mg weekly Placebo Group
    Number of subjects analysed
    53
    53
    53
    28
    Units: Percentage of Participants
        number (confidence interval 95%)
    11.3 (4.3 to 23.0)
    13.2 (5.5 to 25.3)
    7.5 (2.1 to 18.2)
    10.7 (2.3 to 28.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving CDAI remission (CDAI ≤ 150) at Week 8 in the Double-Blind Phase

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    End point title
    		 Percentage of Participants Achieving CDAI remission (CDAI ≤ 150) at Week 8 in the Double-Blind Phase
    End point description
    1) Clinical remission was defined as Crohn’s Disease Activity Index (CDAI) ≤ 150 at Week 8. 2) Participants in the Full Analysis Set set were analyzed. 3) Week 8 refers to the analysis window of day 43 to day 70 and prior to the first open-label dose date. 4) Participants with missing CDAI score at Week 8 analysis visit were imputed as not achieving CDAI remission.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Andecaliximab 150 mg every 2 weeks Andecaliximab 150 mg weekly Andecaliximab 300 mg weekly Placebo Group
    Number of subjects analysed
    53
    53
    53
    28
    Units: Percentage of Participants
        number (confidence interval 95%)
    20.8 (10.8 to 34.1)
    17.0 (8.1 to 29.8)
    11.3 (4.3 to 23.0)
    21.4 (8.3 to 41.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Mucosal Healing (SES-CD ulcer subscore = 0) at Week 8 of the Double-Blind Phase

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    End point title
    		 Percentage of Participants Achieving Mucosal Healing (SES-CD ulcer subscore = 0) at Week 8 of the Double-Blind Phase
    End point description
    The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The SES-CD size-of-ulcer subscore ranges from 0 (none) to 3 (very large). Mucosal healing at Week 8 was defined as the size-of-ulcer subscore for segments with non-zero baseline value changes to zero at Week 8 AND the size-of-ulcer subscore for segments with zero value at baseline remain zero at Week 8. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD size-of-ulcer subscore at Week 8 analysis visit were imputed as not achieving Mucosal Healing. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Andecaliximab 150 mg every 2 weeks Andecaliximab 150 mg weekly Andecaliximab 300 mg weekly Placebo Group
    Number of subjects analysed
    53
    53
    53
    28
    Units: Percentage of participants
        number (confidence interval 95%)
    5.7 (1.2 to 15.7)
    1.9 (0.0 to 10.1)
    1.9 (0.0 to 10.1)
    7.1 (0.9 to 23.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Double-Blind Phase: First Dose of andecaliximab to Week 8; Open-Label Phase: First Dose of open label andecaliximab to the last dose date (maximum: 67 weeks) plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set (Double-blind Phase and Open-label Phase): all participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Double-Blind Andecaliximab 150 mg Q2W (every 2 weeks)
    Reporting group description
    		 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6; 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7

    Reporting group title
    Double-Blind Andecaliximab 150 mg QW (QW = weekly)
    Reporting group description
    		 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks

    Reporting group title
    Double Blind Andecaliximab 300 mg QW
    Reporting group description
    		 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks

    Reporting group title
    Double Blind Placebo
    Reporting group description
    		 2 single-use PFS of placebo coadministered weekly for 8 weeks

    Reporting group title
    Open-Label Andecaliximab QW from Andecaliximab 150 mg Q2W
    Reporting group description
    		 Participants from the Andecaliximab 150 mg Q2W group in the Double-blind Phase, who received open-label andecaliximab 150 mg weekly.

    Reporting group title
    Open-Label Andecaliximab QW from Andecaliximab 150 mg QW
    Reporting group description
    		 Participants from the Andecaliximab 150 mg QW group in the Double-blind Phase, who received open-label andecaliximab 150 mg weekly.

    Reporting group title
    Open-Label Andecaliximab QW from Andecaliximab 300 mg QW
    Reporting group description
    		 Participants from Andecaliximab 300 mg QW in the Double-blind Phase who received open-label andecaliximab 150 mg weekly.

    Reporting group title
    Open-Label Andecaliximab QW from Placebo
    Reporting group description
    		 Participants from the Placebo group in the Double-blind Phase, who received open-label andecaliximab 150 mg weekly.

    Serious adverse events
    		 Double-Blind Andecaliximab 150 mg Q2W (every 2 weeks) Double-Blind Andecaliximab 150 mg QW (QW = weekly) Double Blind Andecaliximab 300 mg QW Double Blind Placebo Open-Label Andecaliximab QW from Andecaliximab 150 mg Q2W Open-Label Andecaliximab QW from Andecaliximab 150 mg QW Open-Label Andecaliximab QW from Andecaliximab 300 mg QW Open-Label Andecaliximab QW from Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 53 (1.89%)
    6 / 53 (11.32%)
    8 / 53 (15.09%)
    3 / 28 (10.71%)
    9 / 52 (17.31%)
    10 / 48 (20.83%)
    7 / 47 (14.89%)
    6 / 26 (23.08%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Post procedural complication
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    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
    Post procedural haematoma
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 28 (3.57%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    1 / 53 (1.89%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 53 (5.66%)
    2 / 53 (3.77%)
    0 / 28 (0.00%)
    4 / 52 (7.69%)
    5 / 48 (10.42%)
    4 / 47 (8.51%)
    3 / 26 (11.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
    0 / 0
    0 / 4
    0 / 5
    1 / 4
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    2 / 52 (3.85%)
    1 / 48 (2.08%)
    2 / 47 (4.26%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    1 / 53 (1.89%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    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
    Anal fistula
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    1 / 28 (3.57%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    1 / 52 (1.92%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula of small intestine
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    1 / 52 (1.92%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileal stenosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    1 / 52 (1.92%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    1 / 52 (1.92%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 28 (3.57%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    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
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute prerenal failure
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Nephrolithiasis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    1 / 52 (1.92%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    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
    Bacterial pyelonephritis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    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
    Clostridium difficile infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Enteritis infectious
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 28 (3.57%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Hypokalaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double-Blind Andecaliximab 150 mg Q2W (every 2 weeks) Double-Blind Andecaliximab 150 mg QW (QW = weekly) Double Blind Andecaliximab 300 mg QW Double Blind Placebo Open-Label Andecaliximab QW from Andecaliximab 150 mg Q2W Open-Label Andecaliximab QW from Andecaliximab 150 mg QW Open-Label Andecaliximab QW from Andecaliximab 300 mg QW Open-Label Andecaliximab QW from Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 53 (28.30%)
    25 / 53 (47.17%)
    25 / 53 (47.17%)
    16 / 28 (57.14%)
    22 / 52 (42.31%)
    21 / 48 (43.75%)
    17 / 47 (36.17%)
    16 / 26 (61.54%)
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    3 / 52 (5.77%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 53 (7.55%)
    5 / 53 (9.43%)
    1 / 28 (3.57%)
    2 / 52 (3.85%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
    0 / 26 (0.00%)
         occurrences all number
    0
    5
    5
    1
    2
    1
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 53 (0.00%)
    5 / 53 (9.43%)
    2 / 53 (3.77%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 26 (0.00%)
         occurrences all number
    0
    6
    2
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 53 (3.77%)
    6 / 53 (11.32%)
    0 / 28 (0.00%)
    1 / 52 (1.92%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    6
    0
    1
    4
    1
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 53 (5.66%)
    0 / 53 (0.00%)
    4 / 28 (14.29%)
    2 / 52 (3.85%)
    1 / 48 (2.08%)
    2 / 47 (4.26%)
    2 / 26 (7.69%)
         occurrences all number
    1
    3
    0
    5
    2
    1
    2
    3
    Fatigue
         subjects affected / exposed
    6 / 53 (11.32%)
    0 / 53 (0.00%)
    5 / 53 (9.43%)
    1 / 28 (3.57%)
    1 / 52 (1.92%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    6
    0
    5
    1
    1
    1
    0
    0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 53 (1.89%)
    2 / 53 (3.77%)
    2 / 28 (7.14%)
    6 / 52 (11.54%)
    10 / 48 (20.83%)
    4 / 47 (8.51%)
    5 / 26 (19.23%)
         occurrences all number
    1
    1
    2
    2
    8
    13
    4
    5
    Abdominal pain
         subjects affected / exposed
    1 / 53 (1.89%)
    7 / 53 (13.21%)
    4 / 53 (7.55%)
    3 / 28 (10.71%)
    7 / 52 (13.46%)
    1 / 48 (2.08%)
    3 / 47 (6.38%)
    1 / 26 (3.85%)
         occurrences all number
    1
    7
    4
    3
    8
    1
    3
    1
    Nausea
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 53 (1.89%)
    7 / 53 (13.21%)
    5 / 28 (17.86%)
    3 / 52 (5.77%)
    4 / 48 (8.33%)
    1 / 47 (2.13%)
    2 / 26 (7.69%)
         occurrences all number
    3
    1
    7
    5
    3
    4
    1
    2
    Vomiting
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 53 (1.89%)
    1 / 53 (1.89%)
    1 / 28 (3.57%)
    3 / 52 (5.77%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
    0 / 26 (0.00%)
         occurrences all number
    2
    1
    1
    1
    4
    0
    2
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    2 / 28 (7.14%)
    2 / 52 (3.85%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    2
    2
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 53 (7.55%)
    1 / 53 (1.89%)
    2 / 28 (7.14%)
    2 / 52 (3.85%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    2 / 26 (7.69%)
         occurrences all number
    0
    4
    1
    2
    2
    0
    1
    2
    Back pain
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 53 (3.77%)
    0 / 53 (0.00%)
    2 / 28 (7.14%)
    0 / 52 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    2
    0
    2
    0
    1
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 53 (1.89%)
    4 / 53 (7.55%)
    0 / 28 (0.00%)
    4 / 52 (7.69%)
    3 / 48 (6.25%)
    4 / 47 (8.51%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    6
    0
    4
    3
    4
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 53 (3.77%)
    1 / 53 (1.89%)
    1 / 28 (3.57%)
    0 / 52 (0.00%)
    3 / 48 (6.25%)
    1 / 47 (2.13%)
    1 / 26 (3.85%)
         occurrences all number
    1
    2
    1
    1
    0
    3
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    2 / 28 (7.14%)
    1 / 52 (1.92%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    1
    2
    1
    1
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    2
    Rhinitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 28 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    2
    Herpes zoster
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    2 / 28 (7.14%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 53 (5.66%)
    4 / 53 (7.55%)
    1 / 28 (3.57%)
    2 / 52 (3.85%)
    2 / 48 (4.17%)
    1 / 47 (2.13%)
    1 / 26 (3.85%)
         occurrences all number
    1
    3
    4
    1
    2
    3
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Feb 2015
    1. Revised the primary objectives, study design, and criteria for evaluation to address the FDA recommendation to conduct a dose-ranging study and move towards a responder definition (primary efficacy endpoint) in Crohn’s disease that was comprised of both key clinical signs and symptoms as well as endoscopic findings 2. Revised the secondary objectives to address the FDA recommendation to change the CDAI remission objective from a primary objective to a secondary objective 3. Revised the exploratory objectives to reflect changes made in the study design 4. Added that up to 50% of subjects enrolled may have had evidence of fistula at screening 5. Revised study design in response to the FDA recommendation to conduct a dose-ranging study 6. Increased number of subjects planned to accommodate 2 additional treatment groups 7. Revised the inclusion criteria to provide a clearly defined moderately or severely active Crohn’s disease study population from which to assess response and remission based on clinical signs and symptoms as well as endoscopic findings 8. Broadened the exclusion criteria to capture perianal abscess and abscesses involving the urogenital system, which could present in Crohn’s disease and require appropriate antibiotic and/or surgical management 9. Added short bowel syndrome to the exclusion criteria 10. Clarified that all endpoint assessments would be conducted at Week 8 11. Added SES-CD as a validated tool to score the endoscopic findings 12. Provided additional detail regarding screening and randomization procedures 13. Added how the CDAI stool frequency and abdominal pain composite score would be calculated
    10 Mar 2015
    1. Clarified in the exploratory objectives that matrix metallopeptidase-9 (MMP9) activity and MMP9 expression in biopsies would be examined and added biopsy collection time points 2. Clarified the exclusion criteria to allow subjects who have had resected non-melanoma skin cancer to participate in the study 3. Added that the primary analysis would be conducted when all randomized subjects completed the Double-blind Phase or prematurely discontinued 4. Clarified in the study rationale that 300 mg SC dosing occurred weekly and 150 mg SC dosing occurred weekly or every other week 5. Revised dosage and administration of andecaliximab and placebo to allow medical professionals at the site to determine the most suitable area for the SC injections 6. Clarified calculation of the CDAI, PRO2, and full ileocolonoscopy 7. Removed nonessential CDAI assessments and scoring 8. Decreased the number of nonessential biopsies for analysis and clarified the colonoscopy procedure 9. Clarified that subjects could not begin the Open-label Phase prior to completing the Week 8 ileocolonoscopy
    24 Feb 2016
    1. Added an additional exploratory objective to assess long term safety of andecaliximab during the Extended Treatment Phase 2. Added the Extended Treatment Phase to the study design to allow subjects who had completed Week 52 assessments to receive andecaliximab 150 mg for an additional 156 weekly doses 3. Added an additional time point (Week 52/early termination) to the MRE substudy to better ascertain changes in disease activity over time with andecaliximab 4. Clarified that sparse PK samples were not collected at Week 52 and were collected during the Extended Treatment Phase 5. Clarified clinically significant worsening of underlying Crohn’s disease in discontinuation criteria, per VHP conditional approval 6. Clarified prohibited medications during the Extended Treatment Phase 7. Added details and clarification of the MRE substudy procedures

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Nov 2016
    After all participants completed the Double-blind (DB) Phase, a primary efficacy analysis was conducted to evaluate the clinical response, defined as PRO2 score ≤ 8, and the endoscopic response, defined as reduction in the SES-CD of ≥ 50% from baseline. No treatment difference was observed between andecaliximab and placebo. Accordingly, Gilead terminated the Open-label Phase and Extended Treatment Phase of GS-US-395-1663, effective 01 November 2016. A prespecified topline analysis was performed after the last enrolled subject received the 8-week DB induction treatment. Based on this review, Gilead terminated the Open-label and Extended Treatment Phases of the study due to lack of efficacy.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study.
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