Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjogren's Syndrome

    Summary
    EudraCT number
    		 2016-000101-37
    Trial protocol
    		 GR   IT  
    Global end of trial date
    24 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2018
    First version publication date
    09 Aug 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM128-035
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02843659
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, EU Study Start-Up Unit, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    24 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial was to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe pSS as measured by the change from baseline in EULAR SS Disease Activity Index (ESSDAI) at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Oct 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
    Russian Federation: 1
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    United States: 4
    Country: Number of subjects enrolled
    Peru: 1
    Worldwide total number of subjects
    18
    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)
    15
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 45 subjects enrolled, 18 subjects were randomized/treated. 15 subjects didn’t complete the treatment period. The study was terminated and the remaining 15 randomized subjects who had not yet completed the double-blind period entered the follow-up period. Of the 15 subjects who entered the follow-up period, 12 did not complete the follow-up period

    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
    		 BMS-931699/lulizumab injection
    Arm description
    		 (12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lulizumab
    Investigational medicinal product code
    Other name
    BMS-931699
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subcutaneous weekly injection

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subcutaneous weekly injection + daily oral placebo tablets

    Arm title
    		 BMS-986142 50 mg tablet (round) or 150 mg tablet (oval)
    Arm description
    		 For oral administration, 350 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Daily oral tablets + subcutaneous placebo (weekly) injection

    Investigational medicinal product name
    BMS-986142
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral tablets + subcutaneous placebo (weekly) injection

    Arm title
    		 Placebo
    Arm description
    		 For BMS-986142 50 mg tablet (round) or 150 mg tablet
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weekly subcutaneous placebo injection +daily oral placebo tablets

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Other use
    Dosage and administration details
    Weekly subcutaneous placebo injection +daily oral placebo tablets

    Number of subjects in period 1
    		BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Started
    5
    6
    7
    Completed
    1
    0
    2
    Not completed
    4
    6
    5
         Subject Withdrew Consent
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    -
         Administrative Reason by Sponsor
    4
    5
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    BMS-931699/lulizumab injection
    Reporting group description
    		 (12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)

    Reporting group title
    BMS-986142 50 mg tablet (round) or 150 mg tablet (oval)
    Reporting group description
    		 For oral administration, 350 mg

    Reporting group title
    Placebo
    Reporting group description
    		 For BMS-986142 50 mg tablet (round) or 150 mg tablet

    Reporting group values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo Total
    Number of subjects
    		 5 6 7 18
    Age categorical
    Subjects
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 5 5 5 15
        From 65-84 years
    		 0 1 2 3
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 49.2 ± 11.34 51.2 ± 8.77 52.6 ± 13.30 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 5 6 7 18
        Male
    		 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        White|
    		 4 4 7 15
        Black or African American|
    		 0 0 0 0
        Asian|
    		 0 0 0 0
        American Indian or Alaska Native|
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander|
    		 0 0 0 0
        Other|
    		 1 2 0 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    BMS-931699/lulizumab injection
    Reporting group description
    		 (12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)

    Reporting group title
    BMS-986142 50 mg tablet (round) or 150 mg tablet (oval)
    Reporting group description
    		 For oral administration, 350 mg

    Reporting group title
    Placebo
    Reporting group description
    		 For BMS-986142 50 mg tablet (round) or 150 mg tablet

    Primary: Mean change from baseline in ESSDAI

    		 Close Top of page
    End point title
    		 Mean change from baseline in ESSDAI [1]
    End point description
    The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
    End point type
    Primary
    End point timeframe
    At baseline and 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 summary statistics were planned.
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: subjects
        arithmetic mean (standard error)
    ±
    ±
    ±
    Notes
    [2] - This study was terminated early
    [3] - This study was terminated early
    [4] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean Change from baseline in ESSDAI scores at Week 4 and Week 8

    		 Close Top of page
    End point title
    		 Mean Change from baseline in ESSDAI scores at Week 4 and Week 8
    End point description
    The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
    End point type
    Secondary
    End point timeframe
    At baseline, week 4 and week 8
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
    Notes
    [5] - This study was terminated early
    [6] - This study was terminated early
    [7] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean Change from baseline in ESSPRI Score at week 4, week 8, and week 12.

    		 Close Top of page
    End point title
    		 Mean Change from baseline in ESSPRI Score at week 4, week 8, and week 12.
    End point description
    ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains.
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [8] - This study was terminated early
    [9] - This study was terminated early
    [10] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Proportion of subjects with a > = 3 point improvement from baseline in ESSDAI at Week 12

    		 Close Top of page
    End point title
    		 Proportion of subjects with a > = 3 point improvement from baseline in ESSDAI at Week 12
    End point description
    The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    Units: subjects
    Notes
    [11] - This study was terminated early
    [12] - This study was terminated early
    [13] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Proportion of subjects with both >= 3 points improvement in ESSDAI and >= 1 point improvement in ESSPRI from baseline at Week 12

    		 Close Top of page
    End point title
    		 Proportion of subjects with both >= 3 points improvement in ESSDAI and >= 1 point improvement in ESSPRI from baseline at Week 12
    End point description
    The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [14]
    0 [15]
    0 [16]
    Units: subjects
    Notes
    [14] - This study was terminated early
    [15] - This study was terminated early
    [16] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Proportions of subjects with >=1 point of improvement from baseline in ESSPRI

    		 Close Top of page
    End point title
    		 Proportions of subjects with >=1 point of improvement from baseline in ESSPRI
    End point description
    ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [17]
    0 [18]
    0 [19]
    Units: subjects
    Notes
    [17] - This study was terminated early
    [18] - This study was terminated early
    [19] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean Change in baseline in ESSPRI individual component of dryness

    		 Close Top of page
    End point title
    		 Mean Change in baseline in ESSPRI individual component of dryness
    End point description
    ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [20]
    0 [21]
    0 [22]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [20] - This study was terminated early
    [21] - This study was terminated early
    [22] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean Change in baseline in ESSPRI individual component of fatigue

    		 Close Top of page
    End point title
    		 Mean Change in baseline in ESSPRI individual component of fatigue
    End point description
    ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [23]
    0 [24]
    0 [25]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [23] - This study was terminated early
    [24] - This study was terminated early
    [25] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean Change in baseline in ESSPRI individual component of pain

    		 Close Top of page
    End point title
    		 Mean Change in baseline in ESSPRI individual component of pain
    End point description
    ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [26]
    0 [27]
    0 [28]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [26] - This study was terminated early
    [27] - This study was terminated early
    [28] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in unstimulated salivary flow rate

    		 Close Top of page
    End point title
    		 Mean change from baseline in unstimulated salivary flow rate
    End point description
    Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [29]
    0 [30]
    0 [31]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [29] - This study was terminated early
    [30] - This study was terminated early
    [31] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in stimulated salivary flow rate

    		 Close Top of page
    End point title
    		 Mean change from baseline in stimulated salivary flow rate
    End point description
    Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [32]
    0 [33]
    0 [34]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [32] - This study was terminated early
    [33] - This study was terminated early
    [34] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in ocular surface staining

    		 Close Top of page
    End point title
    		 Mean change from baseline in ocular surface staining
    End point description
    The test was performed by instillation of fluorescein dye and either lissamine green or Rose bengal dye to stain the cornea and conjunctiva, respectively. After instilling the dye, the ocular surface was examined through a slit lamp (biomicroscope).
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [35]
    0 [36]
    0 [37]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [35] - This study was terminated early
    [36] - This study was terminated early
    [37] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Schrimer’s test

    		 Close Top of page
    End point title
    		 Mean change from baseline in Schrimer’s test
    End point description
    The test (without anaesthesia) was performed by placing a narrow calibrated filter-paper strip in the inferior cul-de-sac of each eye. Aqueous tear production was measured by the length in millimeters that the strip wets during the 5 minute test period
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [38]
    0 [39]
    0 [40]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [38] - This study was terminated early
    [39] - This study was terminated early
    [40] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in the tear break-up time test

    		 Close Top of page
    End point title
    		 Mean change from baseline in the tear break-up time test
    End point description
    Determined by instilling fluorescein dye and evaluating the stability of the pre-corneal tear film. After several blinks, the tear film is examined using a broad beam of the slit-lamp (biomicroscope) with a cobalt blue filter. The TBUT, defined as the time in seconds between the subjects’s last blink and the first appearance of a random dry spot on the corneal surface, is measured 3 times and the mean value is recorded.
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, and week 12
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [41]
    0 [42]
    0 [43]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
    Notes
    [41] - This study was terminated early
    [42] - This study was terminated early
    [43] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in numeric rating scale (NRS) for mouth, eye and vaginal dryness

    		 Close Top of page
    End point title
    		 Mean change from baseline in numeric rating scale (NRS) for mouth, eye and vaginal dryness
    End point description
    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1–3 = Mild Pain(nagging, annoying, interfering little with ADLs), 4–6 = Moderate Pain (interferes significantly with ADLs), 7–10 = Severe Pain (disabling; unable to perform ADLs)
    End point type
    Secondary
    End point timeframe
    At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [44]
    0 [45]
    0 [46]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 2|
    ±
    ±
    ±
        Week 4|
    ±
    ±
    ±
        Week 6|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 10|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
        Week 18|
    ±
    ±
    ±
    Notes
    [44] - This study was terminated early
    [45] - This study was terminated early
    [46] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in subject global assessment of disease activity (SubGDA)

    		 Close Top of page
    End point title
    		 Mean change from baseline in subject global assessment of disease activity (SubGDA)
    End point description
    The study was terminated for administrative reasons after 18 subjects were enrolled. Of these, only 3 subjects – 2 in the placebo arm, and 1 in the lulizumab 12.5 mg arm reached the end of treatment period at Wk 12. Since it is not appropriate to summarize efficacy in treatment arms with so few observations, no summaries were performed
    End point type
    Secondary
    End point timeframe
    At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [47]
    0 [48]
    0 [49]
    Units: subjects
    arithmetic mean (standard error)
        Week 2|
    ±
    ±
    ±
        Week 4|
    ±
    ±
    ±
        Week 6|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 10|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
        Week 18|
    ±
    ±
    ±
    Notes
    [47] - This study was terminated early
    [48] - This study was terminated early
    [49] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change form baseline in physician global assessment of disease activity (phyGDA)

    		 Close Top of page
    End point title
    		 Mean change form baseline in physician global assessment of disease activity (phyGDA)
    End point description
    The investigator's or physician's overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease.
    End point type
    Secondary
    End point timeframe
    At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [50]
    0 [51]
    0 [52]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 2|
    ±
    ±
    ±
        Week 4|
    ±
    ±
    ±
        Week 6|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 10|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
        Week 18|
    ±
    ±
    ±
    Notes
    [50] - This study was terminated early
    [51] - This study was terminated early
    [52] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in short Form-36 (SF-36)

    		 Close Top of page
    End point title
    		 Mean change from baseline in short Form-36 (SF-36)
    End point description
    First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank(missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, week 12, and week 18
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [53]
    0 [54]
    0 [55]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
        Week 18|
    ±
    ±
    ±
    Notes
    [53] - This study was terminated early
    [54] - This study was terminated early
    [55] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in female Sexual Function Index (FSFI)

    		 Close Top of page
    End point title
    		 Mean change from baseline in female Sexual Function Index (FSFI)
    End point description
    The Female Sexual Function Index (FSFI), a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, week 12, and week 18
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [56]
    0 [57]
    0 [58]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
        Week 18|
    ±
    ±
    ±
    Notes
    [56] - This study was terminated early
    [57] - This study was terminated early
    [58] - This study was terminated early
    No statistical analyses for this end point

    Secondary: Mean change from baseline in work participation and activity impairment questionnaire (WPAI)

    		 Close Top of page
    End point title
    		 Mean change from baseline in work participation and activity impairment questionnaire (WPAI)
    End point description
    Affords calculation of 4 scales to measure the impact of IBD on different domains of impairment in work or other activities: absenteeism, presenteeism (impairment at work), productivity loss (overall work impairment), activity impairment
    End point type
    Secondary
    End point timeframe
    At baseline, week 4, week 8, week 12, and week 18
    End point values
    		 BMS-931699/lulizumab injection BMS-986142 50 mg tablet (round) or 150 mg tablet (oval) Placebo
    Number of subjects analysed
    0 [59]
    0 [60]
    0 [61]
    Units: subjects
    arithmetic mean (standard deviation)
        Week 4|
    ±
    ±
    ±
        Week 8|
    ±
    ±
    ±
        Week 12|
    ±
    ±
    ±
        Week 18|
    ±
    ±
    ±
    Notes
    [59] - This study was terminated early
    [60] - This study was terminated early
    [61] - This study was terminated early
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 18 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received subcutaneous (SC) injection of placebo matched to 12.5 milligram (mg) lulizumab (BMS-931699) weekly (QW) and oral tablets of placebo matched to 350 mg BMS-986142 once daily (QD) for 12 weeks.

    Reporting group title
    BMS-986142 350 mg QD
    Reporting group description
    		 Subjects received oral tablets of 350 mg BMS-986142 QD and placebo matched to SC injection of 12.5 mg lulizumab (BMS-931699) QW for 12 weeks.

    Reporting group title
    Lulizumab (BMS-931699) 12.5mg QW
    Reporting group description
    		 Subjects received SC injection of 12.5 mg lulizumab (BMS-931699) QW and oral tablets of placebo matched to 350 mg BMS-986142 QD for 12 weeks.

    Serious adverse events
    		 Placebo BMS-986142 350 mg QD Lulizumab (BMS-931699) 12.5mg QW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo BMS-986142 350 mg QD Lulizumab (BMS-931699) 12.5mg QW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
    4 / 6 (66.67%)
    4 / 5 (80.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Sensation of foreign body
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Stress fracture
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Soft tissue infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2016
    Corrected name of the PatGDA to SubGDA, provided better description of PK analysis for HCQ, clarified several exclusion criteria, removed cryoglobulins, removed requirement to mask local ESR results, added several abbreviations, added references to appendices, corrected secondary outcome of salivary flow to salivary flow rate, corrected typographical & formatting errors in the Notes section of the Flow Chart/Time and Events Schedule (Table 5.1-2), align the pregnancy section of the protocol with requirements in the BMS informed consent form template, and added Appendices for ACR-EULAR Classification Criteria for Primary Sjögren’s Syndrome, as well as for all rating scales and PROs
    13 Feb 2017
    Added preliminary information regarding two drug-drug interaction studies for BMS-986142 and clarified guidance around certain concomitant medications related to those studies, including removal of hormone-eluting intrauterine devices (IUDs) as an allowable method of highly-effective contraception, changed the duration of male contraception from 90 days to 35 days posttreatment completion, removed the 7 year limitation on the diagnosis of Sjögren’s syndrome for study inclusion, clarified exclusion criteria regarding the severity of pSS complications, added guidance around the use of additional eye preparations during the study, clarified physical examination requirements, clarified the duration of post-study follow-up, clarified when BMS-986142 or matching placebo and hydroxychloroquine (if applicable) should be brought to the investigational site for administration, clarified that all routine safety labs should be performed after a 10 hour fast, removed the Day 29/Week 4 HCQ intensive PK assessment, clarified when a serum pregnancy test is needed, updated the reference information for the ACR-EULAR Classification Criteria for Primary Sjögren’s Syndrome, to note that the paraffin wax method of stimulated salivary flow is the preferred method over moistened gauze, clarified the materials provided, clarified site processing instructions for optional biopsy samples, and corrected typographical errors

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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.

    European Medicines Agency © 1995-Thu May 02 00:33:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA