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    Clinical Trial Results:
    An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials

    Summary
    EudraCT number
    		 2020-001762-11
    Trial protocol
    		 HU   SE   GB   AT   DE  
    Global end of trial date
    30 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    00JBT101-LTS-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Corbus Pharmaceuticals, Inc.
    Sponsor organisation address
    500 River Ridge Drive,, Norwood, Massachusetts, United States, 02062
    Public contact
    Rachael Brake, Corbus Pharmaceuticals, Inc., rachael.brake@corbuspharma.com
    Scientific contact
    Brian Walsh, Corbus Pharmaceuticals, Inc., brian.walsh@corbuspharma.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
    28 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the long-term safety of subjects who received at least one dose of study treatment (lenabasum or placebo) in a Corbus sponsored lenabasum pivotal clinical trial and do not enroll in an open-label extension (OLE) phase of a qualifying trial
    Protection of trial subjects
    This was an observational safety trial without any intervention.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Aug 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    7
    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)
    1
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population comprised consented subjects who completed or discontinued from a Corbus-sponsored pivotal clinical study and did not enter an OLE phase of a Corbus-sponsored pivotal clinical study.

    Pre-assignment
    Screening details
    		 A total of 9 subjects were screened, and 7 subjects were enrolled into the study with 2 screen failures.

    Period 1
    Period 1 title
    Safety follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Safety
    Arm description
    		 Enrolled patients were followed-up every 6 months for the duration of 2 years.
    Arm type
    		 Long term observation

    Investigational medicinal product name
    Lenabasum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were only treated during Study JBT101-CF-002.

    Number of subjects in period 1
    		Safety
    Started
    7
    Completed
    0
    Not completed
    7
         Trial terminated
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Safety follow-up
    Reporting group description
    		 -

    Reporting group values
    		 Safety follow-up Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 28.4 (14 to 37) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    Safety
    Reporting group description
    		 Enrolled patients were followed-up every 6 months for the duration of 2 years.

    Primary: Adverse event incidence

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    End point title
    		 Adverse event incidence [1]
    End point description
    End point type
    Primary
    End point timeframe
    Study duration
    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: It is an observational study, with the objective of collecting long-term safety data. Adverse events were counted and listed.
    End point values
    		 Safety
    Number of subjects analysed
    7
    Units: event
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening until the end of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    All enrolled patients
    Reporting group description
    		 -

    Serious adverse events
    		 All enrolled patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All enrolled patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Distal intestinal obstruction syndrome
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2020
    Protocol amendment 1.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Sep 2020
    Study was early terminated due to Sponsor termination of the lenabasum development program
    -

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