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    Summary
    EudraCT Number:2017-004967-11
    Sponsor's Protocol Code Number:RC17_0021
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-04-06
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2017-004967-11
    A.3Full title of the trial
    Poca
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis.
    A.3.2Name or abbreviated title of the trial where available
    Poca
    A.4.1Sponsor's protocol code numberRC17_0021
    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 SponsorCHU Nantes
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS-PHRCN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointDirection de la recherche
    B.5.3 Address:
    B.5.3.1Street Address5 allée de l'ile de gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number+33253482833
    B.5.5Fax number+33253482836
    B.5.6E-maillaetitia.biron@chu-nantes.fr
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namesuspension de microbiote fécal
    D.3.2Product code PRD5973697
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typea suspension of faecal material
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10000638
    E.1.2Term Active ileal inflammation
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the relapse delay after fecal microbiota transplantation versus sham transplantation for recurrent pouchitis in IPAA for ulcerative colitis.
    E.2.2Secondary objectives of the trial
    Efficacy of fecal microbiota transplantation on the relapse rate at week 24
    Efficacy of fecal microbiota transplantation on the relapse rate at week 52
    Instauration of alternative treatment within week 52
    Safety of a fecal microbiota transplantation in case of pouchitis
    Modifications of the fecal microbiota of a patient with ileal pouch for ulcerative colitis complicated of recurrent pouchitis, in remission after antibiotherapy after fecal transplant microbiota from a healthy donor at week 8
    Evolution of health-related to disability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
    2. Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure.
    3. Willing and able to adhere to the study visit scheduled and other protocol requirements.
    4. Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
    5. Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy.
    6. Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
    7. Subject must affiliation with social security system or beneficiary from such system
    8. Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception
    E.4Principal exclusion criteria
    1. Crohn disease or indeterminate colitis
    2. Anastomotic stenosis
    3. Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
    4. Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
    5. Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit
    6. Prior treatment with a biologic within 3 month prior the transplantation visit
    7. Documented active infection of any kind in the last 6 months
    8. Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)
    9. Infection with chronic HIV
    10. Pregnant female or breastfeeding
    11. Chronic medical or psychiatric disease that may interfere with subject’s ability to comply with study procedures
    12. Administration of investigational drug within 3 months prior to planned FMT
    13. Adults under guardianship, Safeguard justice or trusteeship
    14. Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
    E.5 End points
    E.5.1Primary end point(s)
    Delay between the date of transplantation and the date of the Clinical and endoscopic relapse defined by a Pouchitis Disease Activity Index (Appendix) ≥ 7 points.
    The Pouchitis Disease Activity Index (PDAI) is a 19 point index of pouchitis activity based on both clinical symptoms and endoscopic and histologic findings . Active pouchitis is defined as a PDAI ≥ 7 and remission is defined as a PDAI < 7. Clinical response to treatment can also be quantified by reduction in the PDAI .
    E.5.1.1Timepoint(s) of evaluation of this end point
    106 weeks
    E.5.2Secondary end point(s)
    1- Relapse at week 24 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 24
    2- Relapse at week 52 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 52
    3- Delay within the transplantation and the instauration of an antibiotherapy or alternative treatment (immunosuppressive and/or biotherapy and/or corticotherapy)
    4- Registered of adverse events defined by Common Terminology Criteria for Adverse Events (4.3) during 104 weeks post-transplantation according to ANSM recommendation.
    5- Fecal microbiota engraftment at 8 weeks defined by :
    Sorensen’s index [receiver 8 weeks after FMT vs donor] > Sorensen’s index [receiver 8 weeks after FMT vs receiver before FMT]) with Sorensen’s index [receiver 8 weeks after FMT vs donor] = 0.6. To assess this endpoint, fecal microbiota composition will be analyzed for donor sample, receiver sample before FMT and 8 weeks after FMT, using 16S sequencing (Illumina Miseq technology)
    6- IBD Disability Index at weeks -5, baseline, 8, 24, 52 and unscheduled visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    1_24 weeks
    2_ 52 weeks
    3_ 106 weeks
    4_ 104 weeks post-transplantation
    5_ 8 weeks
    6_ weeks -5, baseline, 8 weeks, 24 weeks, 52weeks and 104 weeks
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months76
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    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 state42
    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)
    The patient recever receive appropriate routine medical.
    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 Decision2018-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-26
    P. End of Trial
    P.End of Trial StatusOngoing
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