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    Clinical Trial Results:
    Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2016-000897-39
    Trial protocol
    		 HU   DE   BE  
    Global end of trial date
    07 Aug 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 May 2019
    First version publication date
    16 Jun 2018
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Adding text to “Limitations and Caveats” section

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-373-1499
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02862574
    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
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@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
    07 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745) versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with moderate to severe rheumatoid arthritis (RA).
    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
    		 Participants remained on their current treatment regimen of a TNF inhibitor and methotrexate.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2016
    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: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    0
    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)
    13
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States. The first participant was screened on 15 December 2016. The last study visit occurred on 07 August 2017.

    Pre-assignment
    Screening details
    		 28 participants were screened.

    Period 1
    Period 1 title
    Double-Blind Treatment 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 300 mg
    Arm description
    		 Andecaliximab 300 mg for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
    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
    300 mg administered once weekly

    Arm title
    		 Andecaliximab 150 mg
    Arm description
    		 Andecaliximab 150 mg + placebo for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
    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
    150 mg administered once 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
    Administered once weekly

    Arm title
    		 Placebo
    Arm description
    		 Placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
    Arm type
    		 Placebo

    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
    Administered once weekly

    Number of subjects in period 1
    		Andecaliximab 300 mg Andecaliximab 150 mg Placebo
    Started
    5
    5
    5
    Completed
    2
    3
    1
    Not completed
    3
    2
    4
         Adverse event, non-fatal
    -
    1
    -
         Study Terminated by Sponsor
    3
    1
    4
    Period 2
    Period 2 title
    Open-Label Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Andecaliximab 300 mg to Andecaliximab 300 mg
    Arm description
    		 Andecaliximab 300 mg for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
    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
    300 mg administered once weekly

    Arm title
    		 Andecaliximab 150 mg to Andecaliximab 300 mg
    Arm description
    		 Andecaliximab 300 mg for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
    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
    150 mg administered once 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
    Administered once weekly

    Arm title
    		 Placebo to Andecaliximab 300 mg
    Arm description
    		 Andecaliximab 300 mg for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
    Arm type
    		 Placebo

    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
    Administered once weekly

    Number of subjects in period 2
    		Andecaliximab 300 mg to Andecaliximab 300 mg Andecaliximab 150 mg to Andecaliximab 300 mg Placebo to Andecaliximab 300 mg
    Started
    2
    3
    1
    Completed
    0
    0
    0
    Not completed
    2
    3
    1
         Study Terminated by Sponsor
    2
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Andecaliximab 300 mg
    Reporting group description
    		 Andecaliximab 300 mg for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Andecaliximab 150 mg
    Reporting group description
    		 Andecaliximab 150 mg + placebo for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group values
    		 Andecaliximab 300 mg Andecaliximab 150 mg Placebo Total
    Number of subjects
    		 5 5 5 15
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ( 16.3 ) 57 ( 9.3 ) 58 ( 5.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 4 4 11
        Male
    		 2 1 1 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 2 0 2
        Not Hispanic or Latino
    		 5 3 5 13
    Race
    Units: Subjects
        White
    		 3 5 4 12
        Black
    		 2 0 1 3
    Disease Activity Score Creactive Protein (DAS28(CRP))
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 5.79 ( 0.814 ) 5.90 ( 0.752 ) 5.69 ( 0.887 ) -

    End points

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    End points reporting groups
    Reporting group title
    Andecaliximab 300 mg
    Reporting group description
    		 Andecaliximab 300 mg for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Andecaliximab 150 mg
    Reporting group description
    		 Andecaliximab 150 mg + placebo for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
    Reporting group title
    Andecaliximab 300 mg to Andecaliximab 300 mg
    Reporting group description
    		 Andecaliximab 300 mg for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Andecaliximab 150 mg to Andecaliximab 300 mg
    Reporting group description
    		 Andecaliximab 300 mg for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Placebo to Andecaliximab 300 mg
    Reporting group description
    		 Andecaliximab 300 mg for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Primary: Change From Baseline in DAS28(CRP) at Week 12

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    End point title
    		 Change From Baseline in DAS28(CRP) at Week 12 [1]
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set (all randomized participants who received at least 1 dose of study drug) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline; Week 12
    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 statistical comparison was planned or performed.
    End point values
    		 Andecaliximab 300 mg Andecaliximab 150 mg Placebo
    Number of subjects analysed
    2
    3
    3
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.13 ( 0.115 )
    -1.51 ( 0.670 )
    -0.36 ( 0.353 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants That Achieve DAS28(CRP) ≤ 3.2 at Week 12

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    End point title
    		 Percentage of Participants That Achieve DAS28(CRP) ≤ 3.2 at Week 12
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Andecaliximab 300 mg Andecaliximab 150 mg Placebo
    Number of subjects analysed
    5
    5
    5
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants That Achieve DAS28(CRP) < 2.6 at Week 12

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    End point title
    		 Percentage of Participants That Achieve DAS28(CRP) < 2.6 at Week 12
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Andecaliximab 300 mg Andecaliximab 150 mg Placebo
    Number of subjects analysed
    5
    5
    5
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Andecaliximab

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    End point title
    		 Plasma Concentration of Andecaliximab
    End point description
    The plasma concentrations of andecaliximab were not collected and were not analyzed.
    End point type
    Secondary
    End point timeframe
    Day 4 or 6 (± 1 day)
    End point values
    		 Andecaliximab 300 mg Andecaliximab 150 mg Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [2] - The plasma concentrations of andecaliximab were not collected and were not analyzed.
    [3] - The plasma concentrations of andecaliximab were not collected and were not analyzed.
    [4] - The plasma concentrations of andecaliximab were not collected and were not analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to the last dose date (maximum: 127 days) plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: participants who received at least 1 dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Andecaliximab 300 mg (Double-Blind)
    Reporting group description
    		 Andecaliximab 300 mg for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Andecaliximab 150 mg (Double-Blind)
    Reporting group description
    		 Andecaliximab 150 mg + placebo for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Placebo (Double-Blind)
    Reporting group description
    		 Placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Reporting group title
    Andecaliximab 300 mg (Open-Label)
    Reporting group description
    		 Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

    Serious adverse events
    		 Andecaliximab 300 mg (Double-Blind) Andecaliximab 150 mg (Double-Blind) Placebo (Double-Blind) Andecaliximab 300 mg (Open-Label)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Andecaliximab 300 mg (Double-Blind) Andecaliximab 150 mg (Double-Blind) Placebo (Double-Blind) Andecaliximab 300 mg (Open-Label)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    2 / 5 (40.00%)
    2 / 5 (40.00%)
    2 / 6 (33.33%)
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Fractured sacrum
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash papular
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Influenza
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2016
    Amendment #1 was initiated to add study drug administration visits to the Schedule of Assessments and to eliminate an un-needed visit. Several points were clarified and several clerical errors were corrected such as biomarker collection time-points.
    23 Sep 2016
    The following changes were made to enhance safety monitoring: ● Added chest x-ray at screening to further exclude active TB or lung disease and annually to monitor for re-activation of disease ● Added annual QuantiFERON-TB Gold test to monitor for re-activation of tuberculosis (TB) ● Added reflex testing for Hepatitis B and C every 3 months if subjects test positive for serology at screening ● Added erythrocyte sedimentation rate (ESR) at all study visits to correlate sedimentation rates with C-Reactive protein (CRP)levels ● Added pregnancy precaution requirements for methotrexate (MTX) ● Added additional hematology and chemistry lab draws at Open Label Extension (OLE) weeks 19, 30, 42, and 54 to monitor for infection. Additional instructions were added for potential re-screening of eligible subjects

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    06 Jun 2017
    Gilead made a decision to discontinue the development of andecaliximab in rheumatoid arthritis. This decision was not due to any safety concerns with andecaliximab or with study procedures. As a result of the decision, Study GS-US-373-1499 was terminated. Because the study was terminated early by the sponsor and only 15 participants were enrolled, no formal statistical testing was completed for the final analysis.
    -

    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.
    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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