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    Clinical Trial Results:
    A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

    Summary
    EudraCT number
    2013-001012-30
    Trial protocol
    IT   AT   BE   PL   DE  
    Global end of trial date
    25 Apr 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jan 2017
    First version publication date
    05 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LTS12593
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01861249
    WHO universal trial number (UTN)
    U1111-1141-4634
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & déloppement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.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
    05 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability of SAR339658.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jul 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects who completed the 8-week treatment in the ACT12688 study (EudraCT no. 2012-002013-19) were offered the option to participate in this long-term study. 6/17 subjects consented in participating in the study prior to the decision to discontinue both studies because of slow enrollment.

    Pre-assignment
    Screening details
    The screening visit was the Week 8 visit of the ACT12688 study. All subjects who consented received SAR339658 with dose regimen adjusted according to the clinical response at Week 8 of the ACT12688 study.

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

    Arms
    Arm title
    SAR339658
    Arm description
    SAR339658 20 mg/kg infusion every 4 weeks (q4w) from Week 2 (if clinical response at Week 8 in ACT12688 trial) or every 2 weeks (q2w) at Weeks 0, 2, 4 and 6 and then q4w (if no clinical response at week 8 in ACT12688 trial) for a total of 62 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Vatelizumab
    Investigational medicinal product code
    SAR339658
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    SAR339658 20 mg/kg infusion over 60 minutes (for subjects weighing <120 kg) or 120 minutes (for subjects weighing >120 kg).

    Number of subjects in period 1
    SAR339658
    Started
    6
    Treated
    6
    Completed
    0
    Not completed
    6
         Sponsor's decision
    3
         Lack of efficacy
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SAR339658
    Reporting group description
    SAR339658 20 mg/kg infusion every 4 weeks (q4w) from Week 2 (if clinical response at Week 8 in ACT12688 trial) or every 2 weeks (q2w) at Weeks 0, 2, 4 and 6 and then q4w (if no clinical response at week 8 in ACT12688 trial) for a total of 62 weeks.

    Reporting group values
    SAR339658 Total
    Number of subjects
    6 6
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    6 6
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    3 3
    Product received in the ACT12688 study
    Units: Subjects
        Placebo
    2 2
        SAR339658
    4 4
    Clinical Response at Week 8 of ACT12688
    Units: Subjects
        Yes
    1 1
        No
    5 5

    End points

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    End points reporting groups
    Reporting group title
    SAR339658
    Reporting group description
    SAR339658 20 mg/kg infusion every 4 weeks (q4w) from Week 2 (if clinical response at Week 8 in ACT12688 trial) or every 2 weeks (q2w) at Weeks 0, 2, 4 and 6 and then q4w (if no clinical response at week 8 in ACT12688 trial) for a total of 62 weeks.

    Subject analysis set title
    SAR339658 - Post-Treatment Follow-up
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received at least one dose of SAR339658 and consented in participating in the post-treatment long term safety follow-up.

    Primary: Number of Subjects Who Experienced Adverse Events

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    End point title
    Number of Subjects Who Experienced Adverse Events [1]
    End point description
    Reported adverse events (AEs) were classified according to seriousness and outcome. Analysis was performed on the safety population that included all subjects who received at least 1 dose of the product in this extension study.
    End point type
    Primary
    End point timeframe
    From enrollment in the study up to the last visit in the study (17 weeks max instead of 69 as planned)
    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: The endpoint is descriptive in nature.
    End point values
    SAR339658
    Number of subjects analysed
    6
    Units: subjects
        Any AEs
    5
        - Serious AEs
    0
        - AEs leading to treatment discontinuation
    0
        - AEs leading to death
    0
        AEs after 1st dose in the study
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Abnormality in Laboratory Tests and/or Vital Signs

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    End point title
    Number of Subjects with Clinically Significant Abnormality in Laboratory Tests and/or Vital Signs
    End point description
    Laboratory tests included hematology; liver function test; lipids profile; renal function test; electrolytes and urine analysis. Vital signs included temperature; blood pressure; heart rate and respiration rate. Analysis was performed on safety population.
    End point type
    Secondary
    End point timeframe
    From enrollment in the study up to the last visit in the study (17 weeks max instead of 69 as planned).
    End point values
    SAR339658
    Number of subjects analysed
    6
    Units: subjects
        Laboratory tests
    0
        Vital signs
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Remission (Per Mayo Score) at Week 62

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    End point title
    Percentage of Subjects with Clinical Remission (Per Mayo Score) at Week 62
    End point description
    Clinical remission per Mayo score was defined as a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point, and with the endoscopic sub-score read by a central reader. The Mayo Score is a discrete ordinal scale to assess ulcerative colitis activity. It is a composite of 4 sub-scores for stool frequency, rectal bleeding, endoscopy, and Physician's Global Assessment (PGAS), each of which ranges from 0 (normal) to 3 (severe disease). Total score ranges from 0 (normal or inactive disease) to 12 (severe disease). Analysis was not performed because of the small number of subjects.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 62
    End point values
    SAR339658
    Number of subjects analysed
    0 [2]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [2] - Endpoint was not analyzed because of the small number of subjects and the shorter follow-up
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Mucosal Healing (Per Mayo Score) at Week 62

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    End point title
    Percentage of Subjects with Mucosal Healing (Per Mayo Score) at Week 62
    End point description
    Mucosal healing was defined as a Mayo endoscopy sub-score of 0 or 1, obtained from colonoscopy (read by a central reader). Possible sub-scores were as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, and mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, and erosions), 3 = Severe disease (spontaneous bleeding, ulceration). Analysis was not performed because of the small number of subjects.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 62
    End point values
    SAR339658
    Number of subjects analysed
    0 [3]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [3] - Endpoint was not analyzed because of the small number of subjects and the shorter follow-up.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Partial Mayo Score at Week 10, 22, 34, 46 and 58

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    End point title
    Change From Baseline in the Partial Mayo Score at Week 10, 22, 34, 46 and 58
    End point description
    Partial Mayo score is calculated as a sum of three sub-scores for stool frequency, rectal bleeding and PGAS. It is in a range from 0-9 points; higher partial Mayo scores indicate more severe disease. Analysis was not performed because of the small number of subjects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 10, 22, 34, 46 and 58
    End point values
    SAR339658
    Number of subjects analysed
    0 [4]
    Units: Units on scale
        number (not applicable)
    Notes
    [4] - Endpoint was not analyzed because of the small number of subjects and the shorter follow-up.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 34 and 62

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    End point title
    Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 34 and 62
    End point description
    The IBDQ is a self-administered 32-item questionnaire that evaluates the disease specific quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The total IBDQ score is the sum of the responses to the individual questions and can range from 32 to 224; higher scores indicating a better quality of life. Analysis was not performed because of the small number of subjects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 34, Week 62
    End point values
    SAR339658
    Number of subjects analysed
    0 [5]
    Units: Units on scale
        number (not applicable)
    Notes
    [5] - Endpoint was not analyzed because of the small number of subjects and the shorter follow-up.
    No statistical analyses for this end point

    Other pre-specified: Long Term Safety Follow-up: Number of subjects opportunistic or Progressive Multifocal Leukoencephalopathy (PML)

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    End point title
    Long Term Safety Follow-up: Number of subjects opportunistic or Progressive Multifocal Leukoencephalopathy (PML)
    End point description
    Subjects were contacted by phone at 3, 6, 12, 18 and 24 months post-treatment. During the phone contact, subject was asked specific questions regarding any new signs or symptoms indicative of infection. Any positive findings on questioning were expeditiously referred to a physician for additional evaluation. If any abnormal signs and symptoms are observed or identified, the subject was subsequently referred to an infectious decease specialist or a neurologist for a complete assessment.
    End point type
    Other pre-specified
    End point timeframe
    Up to 24 months after the last dose of investigational medicinal product (IMP) [long-term safety follow-up]
    End point values
    SAR339658 - Post-Treatment Follow-up
    Number of subjects analysed
    6
    Units: subjects
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (17 weeks max) regardless of seriousness or relationship to study drug.
    Adverse event reporting additional description
    Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during the ‘on treatment period’ (from the first dose in the study up to the last visit in the study).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    SAR339658
    Reporting group description
    Subjects with clinical response at Week 8 in study ACT12688 received SAR339658 20 mg/kg q4w. Subjects with no clinical response at week 8 in study ACT12688 received SAR339658 20 mg/kg q2w for eight weeks followed by q4w.

    Serious adverse events
    SAR339658
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    SAR339658
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Atrial Septal Defect
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dental Caries
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Night Sweats
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Infections and infestations
    Herpes Zoster
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    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 number of subjects enrolled was much smaller than planned (6 instead of 80) because of early termination due to slow enrollment.
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