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    Clinical Trial Results:
    PHASE III, MULTI-CENTER, RANDOMIZED, 48 WEEKS, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CER-001 ON VESSEL WALL AREA IN PATIENTS WITH GENETICALLY DEFINED FAMILIAL PRIMARY HYPOALPHALIPOPROTEINEMIA AND RECEIVING BACKGROUND OPTIMIZED LIPID THERAPY, WITH OPTIONAL OPEN-LABEL SAFETY EXTENSION

    Summary
    EudraCT number
    		 2015-003713-23
    Trial protocol
    		 NL   BE   FR  
    Global end of trial date
    21 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2019
    First version publication date
    28 Dec 2019
    Other versions
    Summary report(s)
    		 TANGO study CSR synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    CER-001-CLIN-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CERENIS THERAPEUTICS SA
    Sponsor organisation address
    33-43 Avenue Georges Pompidou, BALMA, France, 31130
    Public contact
    Mrs Constance KEYSERLING, CERENIS THERAPEUTICS, 0033 673045380, cpeyrottes@abionyx.com
    Scientific contact
    Mrs Constance KEYSERLING, CERENIS THERAPEUTICS, 0033 673045380, cpeyrottes@abionyx.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
    26 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of 24 weeks treatment with CER-001 on carotid Mean Vessel Wall Area (MVWA) as compared to placebo using 3T magnetic resonance imaging (3T-MRI); To evaluate the safety and tolerability of CER-001 administered for 24 weeks
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 2015
    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
    Netherlands: 19
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    53
    EEA total number of subjects
    36
    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)
    52
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 53 patients had to be screened to randomize 30 patients.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% Sodium Chloride Injection, USP (or equivalent ex-US) labelled and distributed by Catalent.

    Arm title
    		 CER-001
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CER-001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Based on patient weight at Screening (8 mg/mL), using sodium chloride 0.9% injection, diluted all doses to an uniform administration volume of 250 mL.

    Number of subjects in period 1 [1]
    		Placebo CER-001
    Started
    10
    20
    Completed
    9
    13
    Not completed
    1
    7
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    -
    4
         Sponsor decision, lack of efficacy
    1
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 53 patients were screened and only 30 were randomized due to screen Failure.

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    CER-001
    Reporting group description
    		 -

    Primary: Change from baseline in carotid artery mean vessel wall area at 24 weeks

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    End point title
    		 Change from baseline in carotid artery mean vessel wall area at 24 weeks [1]
    End point description
    End point type
    Primary
    End point timeframe
    24 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: A linear mixed-effect model was used for the analysis of this primary outcome. Nevertheless, despite a tendency regarding W24 visit and CER-001 treatment, no significant association was evidenced regarding the effect of CER-001 on carotid artery MVWA within 24 weeks of treatment (parameter estimate = -1.46; P-value = 0.051).
    End point values
    		 Placebo CER-001
    Number of subjects analysed
    10
    17
    Units: mm²
        arithmetic mean (standard deviation)
    -0.23 ± 1.36
    0.33 ± 1.42
    No statistical analyses for this end point

    Secondary: Change from baseline MVWA in the carotid artery at 8 weeks

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    End point title
    		 Change from baseline MVWA in the carotid artery at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Placebo CER-001
    Number of subjects analysed
    10
    16
    Units: mm²
        arithmetic mean (standard deviation)
    -0.72 ± 1.74
    0.25 ± 0.97
    No statistical analyses for this end point

    Secondary: Change from baseline MVWA in the carotid at 48 weeks

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    End point title
    		 Change from baseline MVWA in the carotid at 48 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Placebo CER-001
    Number of subjects analysed
    9
    15
    Units: mm²
        arithmetic mean (standard deviation)
    0.11 ± 1.99
    0.05 ± 1.22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All observed or volunteered adverse events occurring during the study period, at any time from the signature of the informed consent until the final study evaluation, regardless of treatment group or suspected causal relationship to study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Details are provided on the attached CSR synopsis

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Nov 2015
    • Changes in the study phase from II/III to phase III • Clarification of the study objective by deleting the efficacy and safety evaluation of cer-001 on ApoA 1 • Update of the study methodology by adding clarification to the genetically defined familial primary hypoalphalipoproteinemia : FPHA – mutation in ApoA1 and/or ABCA1 gene, • Update of number of patients and the sample size calculation with a total of 30 patients instead of approximately 30 patients, • Modifications of study population • Update of the section 5 Risk Benefit Statement, since the contrast agent use was not requested for the MRIs in this study, • Update of the section 6.1 – overview of the study design and dose regimen selection, with addition of a time window of +/- 2 days around the strict weekly or biweekly date, • Update of the section 6.4 – Number of patients and assignment to treatment group, for clarification, • Minor modifications / clarifications of study procedures and the flowchart, • Update of the Section 8.5.1 - Assessment of Vascular Structure of the Carotid and Femoral with 3T-MRI with addition of a time window of +/- 7 days around the strict date, • Update of Section 8.6 – Assessments and Procedures for Patients who Prematurely Discontinue Study Medication, by deleting the following condition: “In case of stopping prematurely study medication because of positive testing for anti-ApoA-1 antibody, patient should also to come back monthly for testing until the anti-ApoA-1 antibodies level returns to screening value”, • Update of the Section 8.7.5 – Immunogenicity Testing by clarification that in case of positive result for the presence of neutralizing anti-ApoA-1 antibody at the end of treatment period visit, the patients must return monthly for testing until the antibodies return to screening value, • Update of the Section 12.5 - Populations for Analysis, by modifiying the ITT population into midfied mITT population
    13 Dec 2016
    • Addition of an open-labeled safety extension phase after the 48 weeks of blinded treatment as described in the protocol version 2.0 19NOV2015, • Update of the planned recruitment period and anticipated study duration, • Update of the objectives and parameters related to open-labeled safety extension study, • Redefinition of study population with the update of ApoA-1 level as ≤110 mg/dL and HDL level as ≤ 35 mg/dL or 0.9 mmol/L, • Clarification to the inclusion criterion n°6 regarding the stable lipid lowering therapies definition • Addition of inclusion criteria for background symptomatic or asymptomatic cardiovascular disease, ApoA-1 level ≤ 110 mg/dL and HDL-cholesterol level ≤ 35 mg/dL or 0.9 mmol/L

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 Dec 2018
    Results from the double-blind portion of the TANGO STUDY were analyzed and showed that although no major treatment-related adverse events were observed, confirming the safety and good tolerance profile of CER-001, there was also no evidence of benefit since analysis of the primary efficacy Endpoint data did not show a statistically significant reduction in carotid atheroma plaque of CER-001 relative to placebo treatment. In view of this lack of benefit to patients, the trial was terminated early.
    -

    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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