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    Summary
    EudraCT Number:2019-003816-29
    Sponsor's Protocol Code Number:APHP190183
    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:2019-10-14
    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 number2019-003816-29
    A.3Full title of the trial
    Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal
    Transplantation de microbiote fécal dans la maladie de Crohn comme relais après arrêt des anti-TNF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal
    Transplantation de microbiote fécal dans la maladie de Crohn comme relais après arrêt des anti-TNF
    A.3.2Name or abbreviated title of the trial where available
    MIRACLE
    A.4.1Sponsor's protocol code numberAPHP190183
    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 SponsorASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)
    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 supportHelmsley Charitable Trust
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital Saint Louis
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0140 27 57 27
    B.5.5Fax number0144 84 17 01
    B.5.6E-mailcarla.vandenabele@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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 nameFecal microbiota
    D.3.4Pharmaceutical form Rectal solution
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP Role
    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 nameFecal microbiota
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 Yes
    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 placeboRectal solution
    D.8.4Route of administration of the placeboRectal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors
    Patients majeurs atteints de la maladie de Crohn diagnostiquée depuis au moins 6 mois et donneurs volontaires sains
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease
    maladie de Crohn
    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 20.0
    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
    Evaluate the clinical efficacy at week 52 (V8) of FMT versus sham transplantation as a maintenance treatment following anti-TNF agent withdrawal, in patients with Crohn’s disease in steroid-free clinical remission for at least 6 months under anti-TNF agent.
    Evaluer l’efficacité clinique à 52 semaines (V8) de la TMF versus la sham-transplantation comme traitement de maintient après sevrage en anti-TNF chez des patients atteints de maladie de Crohn en rémission clinique sans corticostéroïdes depuis au moins 6 mois.
    E.2.2Secondary objectives of the trial
    Comparison between FMT and sham-transplantation on :
    a.Relapse free survival between week 0 (V2) and 52 (V8)
    b.Mucosal healing at week 52 (V8)
    c. Clinical and endoscopic remission at week 52 (V8)
    d. Changes in inflammation at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)
    e. Changes in intestinal microbiota composition at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)
    Objective of any potential ancillary study :
    - Identify potential microorganisms in healthy volunteers donor’s microbiota associated with positive and negative outcome.
    - Identify blood biomarkers and metabolites associated with maintenance of clinical remission.
    Comparaison entre TMF et sham-transplantation :
    a.Survie sans rechute entre la semaine 0 (V2) et la semaine 52 (V8)
    b.Cicatrisation des muqueuses à la semaine 52 (V8)
    c.Rémission clinique et endoscopique à 52 semaines (V8).
    d.Changement dans l’inflammation à 6 semaines (V3), à 12 semaines (V4), à 24 semaines (V5), à 26 semaines (V6), à 48 semaines (V7) et à 52 semaines (V8).
    e. Changement dans la composition du microbiote intestinal à 6 semaines (V3), à 12 semaines (V4), à 24 semaines (V5), à 26 semaines (V6), à 48 semaines (V7) et à 52 semaines (V8)
    Objectifs pour une future étude ancillaire
    - Identifier les micro-organismes potentiels dans le microbiote du donneur volontaire sain associés à des résultats positifs et négatifs
    - Identifier les biomarqueurs sanguins et les métabolites associés au maintien de la rémission clinique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients :
    -Age ≥ 18 years and < 75 years
    -Crohn’s Disease (according to the Lennard-Jones criteria) for at least 6 months
    -Patient in steroid-free clinical remission for at least 6 months under anti-TNF agent (no clinical evidence of flare nor change in CD specific treatment and CDAI <150 the week before inclusion (Addendum 2)) and willing to withdraw anti-TNF treatment
    -Female of child-bearing age with an active contraception and this during at least the period of treatment (week 52)
    -Patient with health insurance (AME except)
    -Informed Written consent

    Healthy volunteers donor : see protocol
    Patient
    -18 ans ≥ âge < 75 ans
    -Maladie de Crohn (selon les critères Lennard-Jones) diagnostiquée depuis au moins 6 mois
    -Patient en rémission clinique sous anti-TNF et sans corticostéroïdes depuis au moins 6 mois (aucune preuve clinique de poussée ou de changement de traitement spécifique à la maladie de Crohn et score CDAI <150 la semaine avant inclusion) et disposé à arrêter le traitement par anti-TNF à la randomisation
    -Femme en âge de procréer avec une contraception active pendant au moins la période de traitement
    -Bénéficiare d’un régime de sécurité sociale (hors AME)
    -Signature du consentement éclairé écrit

    Donneurs volontaires sains : voir protocole
    E.4Principal exclusion criteria
    Patient :
    -Crohn’s Disease complication requiring surgical treatment
    -Contraindication to colonoscopy or anesthesia
    -Pregnancy or breastfeeding during the study (Cf. Addendum 4)
    -Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
    -History of bowel resection
    -Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion.
    -Participation in any other interventional study
    -Patients under legal protection.

    Healthy volunteers donor : see protocol
    Patient
    -Complication de la maladie de Crohn nécessitant un traitement chirurgical
    -Contre-indication à la coloscopie ou l’anesthésie
    -Grossesse ou allaitement (Cf. addendum 4)
    -Diagnostic de la maladie de Crohn limité au tractus gastro-intestinal supérieur (Å“sophage, estomac, duodénum, jéjunum)
    -Antécédant de résection intestinale
    -Stomie actuelle (iléostomie ou colostomie) ou stomie au cours des 6 derniers mois ou toute autre chirurgie intra-abdominale dans les 3 mois précédant l’inclusion
    -Participation à toute autre étude interventionnelle
    -Patient sous protection juridique

    Donneurs volontaires sains : voir protocole
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission (defined by a CDAI <150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8).

    Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline over 2 consecutive weeks and the need to start any new treatment for CD.
    La rémission clinique (définie par un score CDAI < 150) à 52 semaines (V8) en l’absence de poussée de la maladie entre la semaine 0 (coloscopie (V2)) et la semaine 52 (V8).

    La poussée de la maladie est définie par un score CDAI supérieur à 250 point et entre 150 et 250 points avec un écart de 70 points par rapport à la valeur initiale pendant 2 semaines consécutives et le besoin de débuter aucun nouveau traitement pour la maladie de Crohn.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semaines
    E.5.2Secondary end point(s)
    a.Relapse free survival rate from week 0 (V2) to week 52 (V8)
    b.Proportion of endoscopic remission (SES-CD ≤2) at week 52 (V8) and change (in %) in endoscopic score (SES-CD) between week 0 (V2) and 52 (V8)
    c.Clinical remission defined by a CDAI < 150 at week 52; endoscopic remission defined by a SES-CD ≤ 2.
    d.Measures of inflammation: blood cell count, CRP level, fecal calprotectin at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)
    e.Microbiota composition and diversity using 16s sequencing technology at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)
    a. Taux de survie sans rechute de la semaine 0 (V2) à la semaine 52 (V8)
    b. Proportion de rémission endoscopique (CSE-CD ≤2) à la semaine 52 (V8) et variation (en%) du score endoscopique (CSE-CD) entre la semaine 0 (V2) et la 52 (V8)
    c. Rémission clinique définie par un CDAI <150 à la semaine 52; rémission endoscopique définie par un SES-CD ≤ 2.
    d. Mesures de l'inflammation: nombre de cellules sanguines, taux de CRP, calprotectine fécale à la semaine 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) et 52 (V8)
    e. Composition et diversité des microbiotes à l'aide de la technologie de séquençage 16S à la semaine 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) et 52 (V8)
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 0 (V2) to week 52 (V8)
    Semaine 0(v2) à semaine 52 (v8)
    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 No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States No
    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
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    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: 162
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state200
    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
    Aucun
    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 Decision2019-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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