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    Clinical Trial Results:
    A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29)

    Summary
    EudraCT number
    		 2014-001295-65
    Trial protocol
    		 BE   DE   AT   IT  
    Global end of trial date
    07 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Feb 2018
    First version publication date
    03 Feb 2018
    Other versions
    Summary report(s)
    		 CATS29 CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    TXC-CD-002-2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02327221
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TxCell
    Sponsor organisation address
    Allée de la Nertière, Valbonne Sophia-Antipolis, Les Cardoulines, France, 06560
    Public contact
    Clinical Department, TxCell, +33 (0) 497 218 301, contact@txcell.com
    Scientific contact
    Clinical Department, TxCell, +33 (0) 497 218 301, regulatory@txcell.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
    06 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Controlled versus placebo confirmation of the ability of a single intravenous (i.v.) injection of 1.10^6 cells dose of Ovasave (Ova-Treg cells) to induce a CDAI response (CDAI decrease ≥ 100 points) 6 weeks post administration compared to placebo in patients with moderately to severely active refractory Crohn’s Disease (CD).
    Protection of trial subjects
    Data and Safety Monitoring Board
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2014
    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
    France: 10
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Germany: 7
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    26
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study began on 03 Dec 2014.26 study centres were initiated, of which 11 were active site as follows: 4 centres in France, 3 in Belgium, 3 in Germany and 1 in Austria. 32 patients screened, 26 enrolled, and 7 randomised and received at least 1 administration of study treatment. The clinical trial was halted prematurely on 11 October 2016.

    Pre-assignment
    Screening details
    		 Patients were screened for eligibility against the inclusion criteria in the protocol at the Screening Visit (Visit 1). 32 patients were screened, 26 patients enrolled, and 7 patients were randomised and received at least 1 administration of the study treatment. The clinical trial was halted prematurely on 11 Oct 2016 following TxCell’s decision.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1.10e4
    Arm description
    		 1.10e4 cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ovasave
    Investigational medicinal product code
    Other name
    Ova-Treg
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Injection of 1x10e4 cells at Week 0 (visit 4) and Week 8 (visit 7)

    Arm title
    		 1.10e6
    Arm description
    		 1.10e6 cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ovasave
    Investigational medicinal product code
    Other name
    Ova-Treg
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Injection of 1x10e6 cells at Week 0 (visit 4) and Week 8 (visit 7)

    Arm title
    		 1.10e7
    Arm description
    		 1.10e7 cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ovasave
    Investigational medicinal product code
    Other name
    Ova-Treg
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Injection of 1x10e7 cells at Week 0 (visit 4) and Week 8 (visit 7)

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for Ovasave
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo for Ovasave injection at Week 0 and week 8

    Number of subjects in period 1 [1]
    		1.10e4 1.10e6 1.10e7 Placebo
    Started
    2
    1
    2
    2
    Completed
    2
    1
    2
    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: 32 subjects were screened and 26 were enrolled but only 7 were randomised and received treatment

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 7 7
    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)
    		 7 7
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 4 4
    Subject analysis sets

    Subject analysis set title
    Full Analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set includes all subjects who were randomised and received at least 1 administration of study treatment which is 7 subjects in total. The clinical trial was halted prematurely on 11 October 2016 following TxCell’s decision.

    Subject analysis sets values
    		 Full Analysis
    Number of subjects
    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)
    7
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    7 ± 7
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    4

    End points

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    End points reporting groups
    Reporting group title
    1.10e4
    Reporting group description
    		 1.10e4 cells

    Reporting group title
    1.10e6
    Reporting group description
    		 1.10e6 cells

    Reporting group title
    1.10e7
    Reporting group description
    		 1.10e7 cells

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    Full Analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set includes all subjects who were randomised and received at least 1 administration of study treatment which is 7 subjects in total. The clinical trial was halted prematurely on 11 October 2016 following TxCell’s decision.

    Primary: CDAI response

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    End point title
    		 CDAI response [1]
    End point description
    The primary clinical efficacy endpoint was the percentage of patients with a CDAI response (CDAI decrease from baseline ≥100 points) in the active group of 1.10e6 Ova-Treg cells, 6 weeks after 1 Ovasave administration (Week 6 [Visit 6])
    End point type
    Primary
    End point timeframe
    6 weeks after IMP administration
    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: As the study was terminated early, planned statistical analyses were not carried out.
    End point values
    		 1.10e4 1.10e6 1.10e7 Placebo Full Analysis
    Number of subjects analysed
    2
    1
    2
    2
    7
    Units: number
        number (not applicable)
    2
    1
    2
    2
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For Acute reactions - within 2 hours of IMP administration For other general reactions - anytime throughout the study
    Adverse event reporting additional description
    The type and incidence of adverse events (AEs) and serious adverse events (SAEs) were recorded at all visits and coded according to the medical dictionary for regulatory activities (MedDRA) criteria. Abnormal laboratory results constituted an AE, and were reported as such, if they are considered abnormal within the pathology of this study populatio
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 All subjects who were randomised and received at least 1 administration of study treatment.

    Serious adverse events
    		 All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 7 (57.14%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
    Additional description: Acute renal failure
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    Investigations
    Body temperature decreased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Feeling hot
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Sense of oppression
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Stomatitis
    Additional description: Aphthous stomatis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Iron deficiency
         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
    27 Feb 2015
    To propose changes concerning the quality of Ovasave
    20 Jul 2015
    To inform the NCAs and ECs of the 6 participating countries of a temporary halt of CATS29 study since 07 July 2015. This decision followed ANSM decision S15/217 (dated 07 July 2015) to suspend the manufacturing authorisation M14/298 granted to the TxCell Besançon site, the only site allowed to produce the IMP.
    02 Dec 2015
    To request the modification of the clinical study protocol while CATS29 study remained on hold. The main change was proposal of a new study design with 2 arms (Ovasave at the 1.10e6 cells dose versus placebo) instead of 4 arms (Ovasave at three doses of 1.10e4, 1.10e6, 1.10e7 cells versus placebo). The primary objective, study hypothesis and sample size calculations remained unchanged on the controlled assessment of the 1.10e6 cells dose versus placebo
    25 Feb 2016
    • To request the authorisation to restart the study • To modify the clinical study protocol • To produce the IMP by a new manufacturer with the quality section of the IMPD updated accordingly, and few quality related changes
    14 Apr 2016
    • To address the points raised by P-NCAs in the email dated 07 Apr 2016 while rejecting VHP555 SA4 • In addition to the changes already described in the Amendment 4, its clarified version addressed VHP concerns regarding the comparability between Ovasave batches manufactured at the initial and the new manufacturing site following manufacturer change

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    07 Jul 2015
    The study was temporarily halted on 07 July 2015 due to the decision of the Agence National de Sécurité du Médicament et des produits de santé (ANSM) to suspend the manufacturing authorisation of the only site used for production of clinical supplies for CATS29 (decision S15/217 dated 07 July 2015). National Competent Authorities (NCAs) and ECs were all informed about this temporary halt. The ANSM decision to suspend the manufacturing authorisation followed an ANSM inspection at TxCell’s Besançon site in April 2015. The patients who had already received study treatment were followed as per protocol and all other patients were withdrawn from the study. TxCell decided to end the trial on 11 October 2016, due to challenges in Ovasave manufacturing (with suspension of the manufacturing site and transfer to a new manufacturing site), and a need to finalise and GMP-validate a more efficient manufacturing process prior to the conduct of clinical trials with Ovasave.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As well as countries listed in the summary, this trial additionally ran in FR & UK Due to manufacturing challenges and premature termination, the limited data obtained in this study does not allow for any firm conclusion on either efficacy or safety
    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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