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    Clinical Trial Results:
    A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis

    Summary
    EudraCT number
    		 2015-002192-23
    Trial protocol
    		 DE   BE   ES  
    Global end of trial date
    21 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jun 2018
    First version publication date
    21 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-404-1808
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02759562
    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
    21 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1 % predicted) in adults with cystic fibrosis (CF) after 8 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
    04 Nov 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
    Spain: 1
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Australia: 1
    Worldwide total number of subjects
    6
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Australia and Europe. The first participant was screened on 04 November 2016. The last study visit occurred on 21 July 2017.

    Pre-assignment
    Screening details
    		 26 participants were screened.

    Period 1
    Period 1 title
    Double-Blind Treatment Period (8 Weeks)
    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
    Arm description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for 8 weeks
    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
    600 mg administered weekly for 8 doses

    Arm title
    		 Placebo
    Arm description
    		 Placebo administered via subcutaneous injection weekly for 8 doses
    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 weekly for 8 doses

    Number of subjects in period 1
    		Andecaliximab Placebo
    Started
    3
    3
    Completed
    3
    3
    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 600 mg to Andecaliximab 600 mg
    Arm description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks
    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
    600 mg administered weekly for up to 16 weeks

    Arm title
    		 Placebo to Andecaliximab 600 mg
    Arm description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks
    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
    600 mg weekly for up to 16 weeks

    Number of subjects in period 2 [1]
    		Andecaliximab 600 mg to Andecaliximab 600 mg Placebo to Andecaliximab 600 mg
    Started
    2
    2
    Completed
    0
    0
    Not completed
    2
    2
         Withdrew Consent
    1
    -
         Study Terminated by Sponsor
    1
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 2 participants completed the Double-Blind Phase, but did not enter in the Open-Label Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Andecaliximab
    Reporting group description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for 8 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered via subcutaneous injection weekly for 8 doses

    Reporting group values
    		 Andecaliximab Placebo Total
    Number of subjects
    		 3 3 6
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.0 ( 20.42 ) 43.3 ( 10.02 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 0 2
        Male
    		 1 3 4
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 3 3 6
    Race
    Units: Subjects
        White
    		 3 3 6
    Pre-bronchodilator Forced expiratory volume in 1 second (FEV1) % predicted
    FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition.
    Units: percent
        arithmetic mean (standard deviation)
    		 49.7 ( 8.70 ) 59.1 ( 19.26 ) -
    Post-bronchodilator FEV1 % predicted
    Units: percent
        arithmetic mean (standard deviation)
    		 52.1 ( 5.90 ) 64.6 ( 20.58 ) -

    End points

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    End points reporting groups
    Reporting group title
    Andecaliximab
    Reporting group description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for 8 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered via subcutaneous injection weekly for 8 doses
    Reporting group title
    Andecaliximab 600 mg to Andecaliximab 600 mg
    Reporting group description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks

    Reporting group title
    Placebo to Andecaliximab 600 mg
    Reporting group description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks

    Primary: Absolute change in pre-bronchodilator FEV1 percent predicted from Baseline to Week 8

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    End point title
    		 Absolute change in pre-bronchodilator FEV1 percent predicted from Baseline to Week 8 [1]
    End point description
    Full Analysis Set: all randomized participants who took at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline; 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 statistical comparison was performed.
    End point values
    		 Andecaliximab Placebo
    Number of subjects analysed
    3
    3
    Units: percent
        arithmetic mean (standard deviation)
    -2.10 ( 4.446 )
    2.90 ( 3.461 )
    No statistical analyses for this end point

    Secondary: Absolute change in post-bronchodilator FEV1 percent predicted from Baseline to Week 8

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    End point title
    		 Absolute change in post-bronchodilator FEV1 percent predicted from Baseline to Week 8
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline; Week 8
    End point values
    		 Andecaliximab Placebo
    Number of subjects analysed
    3
    3
    Units: percent
        arithmetic mean (standard deviation)
    1.01 ( 4.534 )
    -1.45 ( 1.655 )
    No statistical analyses for this end point

    Secondary: Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

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    End point title
    		 Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline; Week 8
    End point values
    		 Andecaliximab Placebo
    Number of subjects analysed
    3
    3
    Units: percent of FEV1 % predicted
        arithmetic mean (standard deviation)
    -3.85 ( 9.009 )
    4.41 ( 4.196 )
    No statistical analyses for this end point

    Secondary: Relative change in post-bronchodilator FEV1 percent predicted from Baseline to Week 8

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    End point title
    		 Relative change in post-bronchodilator FEV1 percent predicted from Baseline to Week 8
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline; Week 8
    End point values
    		 Andecaliximab Placebo
    Number of subjects analysed
    3
    3
    Units: percent of FEV1 % predicted
        arithmetic mean (standard deviation)
    2.28 ( 9.323 )
    -1.98 ( 1.749 )
    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 plus 30 days (maximum exposure: 140 days)
    Adverse event reporting additional description
    Safety Analysis Set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Andecaliximab (Double-Blind)
    Reporting group description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for 8 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered via subcutaneous injection weekly for 8 doses

    Reporting group title
    Andecaliximab (Open-Label)
    Reporting group description
    		 Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks

    Serious adverse events
    		 Andecaliximab (Double-Blind) Placebo Andecaliximab (Open-Label)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Andecaliximab (Double-Blind) Placebo Andecaliximab (Open-Label)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    Investigations
    Bacterial test positive
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Cystic fibrosis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Injection site pruritus
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site bruising
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site erythema
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site haematoma
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site rash
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    1
    0
    2
    Wheezing
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    25 May 2016
    • Updated bilirubin exclusion criteria from 3 times the ULN to 2 times the ULN • Added additional ECG monitoring at Baseline, Week 4, 8, 16, 24, and 30-day Follow-up. • Added an active plan of soliciting symptoms on a monthly basis by increasing symptom driven PE’s to be conducted monthly, including musculoskeletal symptoms. • Clarified the home health visits, timing of those visits and procedures conducted • Clarified the use of antibiotic use in the study and those that are to be excluded • Clarified pre-bronchodilator PEFR will be collected, not post • Last dose of OLE dosing clarified in schedule of assessments

    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 cystic fibrosis. This decision was not due to any safety concerns with andecaliximab or with study procedures. As a result of the decision, this study was terminated.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated after 6 subjects had been enrolled. Therefore, no inferential analyses were performed.
    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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