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    Summary
    EudraCT Number:2014-001295-65
    Sponsor's Protocol Code Number:TXC-CD-002-2011
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2014-001295-65
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease
    A.3.2Name or abbreviated title of the trial where available
    CATS29
    A.4.1Sponsor's protocol code numberTXC-CD-002-2011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02327221
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTxCell
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTxCell
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTxCell
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressAllée de la Nertière - Les Cardoulines
    B.5.3.2Town/ cityValbonne - Sophia-Antipolis
    B.5.3.3Post code06560
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0) 497 218 301
    B.5.5Fax number+33(0) 493 641 580
    B.5.6E-mailclinical@txcell.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOvasave
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOva-Treg
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeOva-Treg
    D.3.9.3Other descriptive nameAutologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10e6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberOvasave classified as "somatic cel therapy medicinal product", "not combined". Reference: EMA/CAT/765386/2009 (scientific recommendation) and EMA/CAT/38247/2010 (letter)
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to severely active Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Moderately to severely active Crohn's Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    - Safety assessment of a first and second i.v. injection of Ovasave (CATS29-DB) and of a 3rd and 4th i.v. injection of Ovasave (CATS29-OL).
    - Assessment of the efficacy and the safety of the dose 1.10e6 cells compared to Placebo.
    - Assessment at V8 (Week 14) of the safety and efficacy (response and remission) of a second injection of 1.10e6 cells (performed at V7 (Week 8)).
    - Reduction of steroids treatment at V8 (Week 14).
    - Assessment of safety during the 3-year Long-Term Safety Follow-Up after first dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with active refractory Crohn's Disease, meeting the following criteria:

    1) Willing and able to provide written Informed Consent (IC);
    2) Male or Female aged between 18 and 70 (inclusive) years of age;
    3) Crohn's Disease diagnosis defined as patients with medical history of signs, symptoms and biological evidence of active bowel inflammation:
    - Documented Magnetic Resonance Imaging (MRI) or endoscopic evidence of inflammatory bowel disease (IBD), compatible with Crohn's diagnosis at least 1 year prior to V1;
    AND
    - Available endoscopy or MRI, performed within 1 year prior to V1. If the one available has more than 1 year at V1 a new exam (endoscopy or MRI) needs to be performed prior V2;
    4) Documented CDAI (Crohn's Disease Activity Index) ≥ 250 at V1 or within 12 weeks prior to V1;
    5) Elevated High sensitive C-reactive protein (hs-CRP) > 10 mg/L at V1;
    6) Calprotectin ≥ 250 μg/g at V1;
    7) Failure or intolerance to conventional treatments including corticosteroid, immunosuppressant and at least one biologics; and had not responded (primarily failure) or responded and then lost response completely (no response or need to increase the dose / secondary failure) or were intolerant to this therapy at a dose indicated for CD (Refer to Appendix 17.6 for the definition of refractoriness);
    8) Total white cell count between 4.0.10e9 /L and 10.10e6 /L;
    9) Platelets between 150.10e9 and 600.10e9 /L (included);
    10) Hemoglobin between 8.5 g/dL and 16 g/dL;
    11) Full Blood Count (FBC) and biochemistry without any clinically significant abnormalities except if CD-related, at Investigator's discretion;
    12) Prothrombin Time (PT) between 70-100% (or International Normalized Ratio (INR) between 0.8 and 1.2) and activated Partial Thromboplastin Time (aPTT) between 0.8 and 1.2 (Ratio);
    13) Normal, or no clinically significant abnormality in the electrocardiogram (ECG) at Investigator's discretion;
    14) Patients willing and able to observe an intake of ovalbumin through the ingestion of a meringue (cooked pasteurized egg white with sugar) daily after the first administration until the end of the DB-phase and during the OL-phase if the patient receives additional administration.

    Additional eligibility criteria for IMP administration:

    At the Visit 3 (Week -4):

    1) CDAI ≥ 250;
    2) Evidence of inflammation by an elevated hs-CRP value (> 5 mg/L);
    OR elevated calprotectin (≥ 250 μg/g);
    OR endoscopic / MRI evidence of local intestinal inflammation (to be confirmed before V4);
    3) Absence of any of the following conditions:
    - Concomitant abdominal, perianal or anal undrained abscess;
    - Actively draining fistula;
    - Anal or rectal stricture;
    - Clinically active infection.

    At Visit 4 (Week 0): Absence of any of the following conditions:

    - Concomitant abdominal, perianal or anal undrained abscess;
    - Presence of actively draining fistula;
    - Clinically active infection.

    At each subsequent administration visits (V7, V9, V11): Absence of clinically active infection.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1) Current or recent history (within 1 year prior to V1) of major organ or system failure or condition, acute or chronic that in the opinion of the Investigator should preclude enrolment, except Crohn's Disease;
    2) Current or previous history of malignancy except a local basal cell carcinoma without metastases;
    3) History of major immune deficiency disorder, except Crohn's Disease;
    4) Gamma immunoglobulinaemia < 6 g/L at V1 or any signs or history of major immune deficiency disorder;
    5) First degree family or personal history of clinically significant venous, arterial or pulmonary thromboembolism events;
    6) History of thrombocytosis over 600.10e9 / L within 1 year prior to V1;
    7) History of tuberculosis (TB) except if documentation of adequate compliance to treatment is provided; Test to be performed at V1 if not already done in the 12 weeks prior to V1;
    8) Concomitant clinically active infection;
    9) Serious infection (as per definition of sepsis) within 12 weeks prior to V1;
    10) Opportunistic infections within 6 months (26 weeks) prior to V1;
    11) Infectious enteritis within 4 weeks prior to V1;
    12) Evidence or Clostridium difficile at V1;
    13) History of human immunodeficiency virus (HIV);
    14) Recent history of contamination by the Epstein-Barr virus (EBV), Cytomegalovirus (CMV) and/or toxoplasma within 6 months (26 weeks) prior to V1; If EBV or CMV positive at V1, virus load will be performed at V2. If positive at V2, virus load will be assessed again at V3. If decrease, and upon discussion with the medical monitor, the patient could continue the study;
    15) Inflammatory eye disease or pyoderma gangrenosum;
    16) History of intestinal resection or intra-abdominal surgery within 6 months (26 weeks) prior to V1;
    17) Patients with ileostomy or colostomy;
    18) Patients with short bowel syndrome with less than 1.5 m of small bowel;
    19) Complication of Crohn's Disease such as strictures, stenosis, short gut syndrome, penetrating disease, or any other manifestation that might require surgery, could preclude the use of CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with Ovasave;
    20) Intestinal functional fibrotic stricture responsible for the patient's symptoms or previous major gastrointestinal (GI) resection;
    21) Parenteral nutrition if not compatible with the meringue intake;
    22) History of documented hypersensitivity or intolerance to chicken eggs;
    23) History of known hypersensitivity or intolerance to any component of the IMP (Refer to Appendix 17.7 for the composition of the IMP);
    24) Females of childbearing potential who are either pregnant, breastfeeding or without the use of birth control. Female patients of childbearing potential must have a negative pregnancy test at Screening and must agree to use an acceptable method of birth control with a low failure rate (i.e. less than 1% per year) in a consistent and correct manner for the whole duration of the study treatment period and during 12 weeks following the end of the study treatment period (V13/Week 32). Abstinence, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, a contraceptive vaginal ring (e.g. NuvaRing or equivalent) or a contraceptive transdermal patch (e.g. EVRA or equivalent) administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly or a subcutaneous implant of etonogestrel (Implanon or equivalent) for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral ovariectomy. A documented sterilization of the patient's partner is also allowed;
    25) History of poor clinic attendance or, in the opinion of the Investigator, patients considered unlikely to comply with the required visit schedule and other protocol requirements;
    26) Use of any experimental medicinal product within the 12 weeks prior to V1, or during the study, and up to the end of the 3-year Long-Term Safety Follow-Up.
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical efficacy endpoint is the percentage of patients with a CDAI response (CDAI decrease from baseline ≥ 100 points) in the active group of 10^6 Ova-Treg cells, 6 weeks after 1 Ovasave administration (Week 6= V6) compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks after 1 Ovasave administration (Visit 6)
    E.5.2Secondary end point(s)
    - CDAI:

    • Percentage of patients with a CDAI remission (CDAI < 150 points) and response (CDAI decrease from baseline ≥ 100 points) 6 weeks after the second administration (V8=Week 14),
    • Percentage of patients with a CDAI response at each other postbaseline visit,
    • Percentage of patients achieving a CDAI remission (CDAI < 150 points) at each post-baseline visit,
    • Raw value in CDAI total score at each post-baseline visit,
    • Raw value in each CDAI sub-score at each post-baseline visit,
    • Change from baseline in CDAI total score at each post-baseline visit.

    - Steroids sparing effect:

    • Steroid decrease from Visit 7 (Week 8) will be recorded at Visit 8 (Week 14) (including the daily dose taken between V7 and V8),
    • Percentage of patient by decrease steroids dose (decrease in total of 20, 15, 10, 5 or 0 mg/day) at Week 14.

    - Inflammatory markers:

    • Raw value in hs-CRP at each post-baseline visit,
    • Change from baseline in hs-CRP at each post-baseline visit,
    • Raw value in Calprotectin at each post-baseline visit,
    • Change from baseline in Calprotectin at each post-baseline visit.

    - Investigator's opinion on the investigational product:

    • Qualify the investigational product,
    • Would you like to test the investigational product again?
    E.5.2.1Timepoint(s) of evaluation of this end point
    - CDAI:

    • At Visit 8 (Week 14)
    • At each other post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit

    - Steroids sparing effect:

    • At Visit 8 (Week 14)
    • At Visit 8 (Week 14)

    - Inflammatory markers:

    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit

    - Investigator's opinion on the investigational product:

    • At Visit 9 (Week 16) and Visit 13 (Week 32), and at Early Termination Visit (ET)
    • At Visit 9 (Week 16) and Visit 13 (Week 32), and at Early Termination Visit (ET)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 157
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-11
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