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    Clinical Trial Results:
    A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2017-001764-37
    Trial protocol
    		 GB   ES   PT   BG  
    Global end of trial date
    20 Nov 2019

    Results information
    Results version number
    		 v1
    This version publication date
    05 Nov 2020
    First version publication date
    05 Nov 2020
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    GA30066
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03407482
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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
    20 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and efficacy of GDC-0853
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 All Subjects were on immunosuppressants, antimalarials and/or corticosteroids.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jan 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 18
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Brazil: 41
    Country: Number of subjects enrolled
    Chile: 28
    Country: Number of subjects enrolled
    Colombia: 25
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Mexico: 12
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    United States: 18
    Worldwide total number of subjects
    160
    EEA total number of subjects
    14
    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)
    154
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 50 centers in 11 countries.

    Pre-assignment
    Screening details
    		 160 subjects were enrolled into this OLE study and were included in the ITT and Safety populations.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Parent GDC-0853 (200mg) BID
    Arm description
    		 Subjects previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GDC-0853
    Investigational medicinal product code
    Other name
    fenebrutinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GDC-0853 was administered orally twice daily (BID) at a dose of 200mg.

    Number of subjects in period 1
    		Parent GDC-0853 (200mg) BID
    Started
    160
    Completed
    29
    Not completed
    131
         Disease Relapse
    1
         Consent withdrawn by subject
    6
         Data Entry Error
    1
         Adverse event, non-fatal
    12
         Study Terminated By Sponsor
    106
         Non-Compliance With Study Drug
    1
         Pregnancy
    2
         Lost to follow-up
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Parent GDC-0853 (200mg) BID
    Reporting group description
    		 Subjects previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).

    Reporting group values
    		 Parent GDC-0853 (200mg) BID Total
    Number of subjects
    		 160 160
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 154 154
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 42.8 ± 11.5 -
    Sex: Female, Male
    Units:
        Female
    		 155 155
        Male
    		 5 5
    Race/Ethnicity, Customized
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 117 117
        Not Hispanic or Latino
    		 42 42
        Not Stated
    		 1 1
    Race/Ethnicity, Customized
    Race
    Units: Subjects
        American Indian or Alaska native
    		 24 24
        Asian
    		 5 5
        Black or African American
    		 22 22
        Multiple
    		 5 5
        White
    		 104 104

    End points

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    End points reporting groups
    Reporting group title
    Parent GDC-0853 (200mg) BID
    Reporting group description
    		 Subjects previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).

    Primary: Percentage of Subjects With Adverse Events (AEs)

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) [1]
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
    End point type
    Primary
    End point timeframe
    Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
    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 analyses were performed, as this study has only 1 arm.
    End point values
    		 Parent GDC-0853 (200mg) BID
    Number of subjects analysed
    160
    Units: Percentage of Subjects
        number (not applicable)
    64.4
    No statistical analyses for this end point

    Secondary: Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48

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    End point title
    		 Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48
    End point description
    The Systemic Lupus Erythematosus Responder Index (SRI)-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. No subjects were evaluated as a result of early termination of this study due to fenebrutinib not demonstrating improved efficacy compared to placebo across secondary or exploratory endpoints in the parent study (Study GA30044).
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 48
    End point values
    		 Parent GDC-0853 (200mg) BID
    Number of subjects analysed
    0 [2]
    Units: Percentage of Subjects
    Notes
    [2] - Not evaluated due to early termination.
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State

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    End point title
    		 Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State
    End point description
    Population PK model estimated AUC of GDC-0853 From Time 0 to Time t (AUC0-t) at steady-state. AUC was measured in Nanograms (ng) per millilitre(mL)*hour (hr). Please note that for this Outcome Measure, the early termination of the study precluded the conduct of a post hoc population PK analysis due to technical concerns regarding the paucity of useable data and hence data for the (AUC0-t,ss) parameter could not be estimated. 999 = Not Estimable.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
    End point values
    		 Parent GDC-0853 (200mg) BID
    Number of subjects analysed
    160 [3]
    Units: Ng/mL*(hr)
        arithmetic mean (standard deviation)
    999 ± 999
    Notes
    [3] - Not evaluated due to early termination.
    No statistical analyses for this end point

    Secondary: Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)

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    End point title
    		 Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)
    End point description
    Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss). Please note that for this Outcome Measure, the early termination of the study precluded the conduct of a post hoc population PK analysis due to technical concerns regarding the paucity of useable data and hence data for the (Ctrough,ss) parameter could not be estimated. 999 = Not Estimable.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
    End point values
    		 Parent GDC-0853 (200mg) BID
    Number of subjects analysed
    160 [4]
    Units: ng/mL
        arithmetic mean (standard deviation)
    999 ± 999
    Notes
    [4] - Not evaluated due to early termination.
    No statistical analyses for this end point

    Secondary: Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)

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    End point title
    		 Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)
    End point description
    Population PK model estimated plasma decay half life of GDC-0853 at steady-state. Please note that for this Outcome Measure, the early termination of the study precluded the conduct of a post hoc population PK analysis due to technical concerns regarding the paucity of useable data and hence data for the (t1/2,ss) parameter could not be estimated. 999 = Not Estimable.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
    End point values
    		 Parent GDC-0853 (200mg) BID
    Number of subjects analysed
    160 [5]
    Units: hr
        arithmetic mean (standard deviation)
    999 ± 999
    Notes
    [5] - Not evaluated due to early termination.
    No statistical analyses for this end point

    Secondary: Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)

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    End point title
    		 Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)
    End point description
    Population PK model estimated apparent oral clearance of GDC-0853 at steady-state. Please note that for this Outcome Measure, the early termination of the study precluded the conduct of a post hoc population PK analysis due to technical concerns regarding the paucity of useable data and hence data for the (CL/F,ss) parameter could not be estimated. 999 = Not Estimable.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
    End point values
    		 Parent GDC-0853 (200mg) BID
    Number of subjects analysed
    160 [6]
    Units: L/hr
        arithmetic mean (standard deviation)
    999 ± 999
    Notes
    [6] - Not evaluated due to early termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Parent GDC-0853 (200mg) BID
    Reporting group description
    		 Subjects previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).

    Serious adverse events
    		 Parent GDC-0853 (200mg) BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 160 (2.50%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    LUMBAR VERTEBRAL FRACTURE
         subjects affected / exposed
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    SYSTEMIC LUPUS ERYTHEMATOSUS
         subjects affected / exposed
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    CELLULITIS
         subjects affected / exposed
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INFECTIVE TENOSYNOVITIS
         subjects affected / exposed
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Parent GDC-0853 (200mg) BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 160 (19.38%)
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    9 / 160 (5.63%)
         occurrences all number
    9
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    13 / 160 (8.13%)
         occurrences all number
    14
    URINARY TRACT INFECTION
         subjects affected / exposed
    15 / 160 (9.38%)
         occurrences all number
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The study was ended early due to the lack of efficacy seen in the parent study GA30044.
    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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