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    Summary
    EudraCT Number:2020-000599-38
    Sponsor's Protocol Code Number:RC20_0007
    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:2020-06-12
    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 number2020-000599-38
    A.3Full title of the trial
    A phase I/II study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of FR104, a novel antagonist pegylated anti-CD28 Fab’ antibody fragment in de novo renal transplant patients
    Etude de phase I/II destinée à évaluer la sécurité d’emploi, la tolérance, l’efficacité, la pharmacocinétique (PK) et la pharmacodynamie (PD) du FR104, nouvel anticorps monoclonal anti CD28, chez des patients transplantés rénaux de novo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 study of FR104 first administration In patient with Renal Transplantation: FIRsT study
    Étude de phase 1/2 : première administration de FR104 chez des patients ayant une première transplantation rénale : étude FIRsT
    A.3.2Name or abbreviated title of the trial where available
    FIRsT
    A.4.1Sponsor's protocol code numberRC20_0007
    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 SponsorNANTES CHU
    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 supportOSE Immunotherapeutics
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNANTES CHU
    B.5.2Functional name of contact pointLaetitia BERLY
    B.5.3 Address:
    B.5.3.1Street Address5 Allée de l'ile Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number0033253526204
    B.5.5Fax number0033253482836
    B.5.6E-mailbp-prom-regl@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.2.5The 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 nameFR104
    D.3.2Product code FR104
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Kidney transplant
    Transplantés rénaux
    E.1.1.1Medical condition in easily understood language
    Kidney transplant
    Transplantés rénaux
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10051366
    E.1.2Term Kidney graft dysfunction
    E.1.2System Organ Class 100000004863
    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 safety of the FR104 up to 12 months
    Evaluer la sureté du FR104 pendant 12 mois
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of the treatment up to 12 months
    •On the renal function at M6 and M12
    •On Biopsy-proven acute rejection (BPAR) up to M12
    •On clinically-treated acute rejections up to M12
    •On steroid-resistant episodes up to M12
    •On multiples rejection episodes up to M12
    •On chronic allograft nephropathy up to M12
    •On graft survival up to M12
    •Evaluate the treatment failure time
    •Evaluate the first BPAR time (per Banff criteria 2017)
    •Evaluate the appearance of Donor specific Antibodies (DSA)
    •Long-term follow-up (1 year post-treatment)
    Evaluer l’efficacité du traitement
    •Sur la fonction rénale à 6 mois et 12 mois
    •Sur les rejets aigus prouvés par biopsie jusqu'à 12 mois.
    •Sur les rejets aigus médicalement traités jusqu'à 12 mois.
    •Sur les rejets résistants aux stéroïdes jusqu’ à 12 mois.
    •Sur les épisodes de rejet multiples jusqu'à 12 mois
    •Sur la néphropathie chronique d'allogreffe jusqu'à 12 mois.
    •Sur la survie du greffon jusqu'à 12 mois
    •Evaluer le délai en cas d’échec de traitement
    •Evaluer le délai d’apparition du premier rejet aïgu prouvé par biopsie
    •Evaluer l’apparition des DSA
    •Suivi sur le long-terme (1 an après la fin du traitement)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Male or female ≥ 18 years old
    2)Signed and dated written informed consent prior to any study procedure
    3)First kidney transplantation
    4)Willing and able to participate to the study
    5)Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception during the clinical trial (oral contraception, implant or IUD) throughout the study period and for 90 days after the last dose of FR104(see EMA guidance on section 2.2.2)
    6)WOCBP must have a negative urinary pregnancy test the day of transplantation
    7)All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agree to no sperm donation until the end of the study, or for 90 days after the last dose of FR104, whichever is longer
    8)Recipient of a kidney from deceased donor
    9)Recipient of a de novo kidney transplant able to start the immunosuppressive regimen at the protocol-specified time point
    10)Recipients of a kidney with a cold ischemia time (CIT) < 36 hours
    11)Patients with French social security
    1) Homme ou femme de 18 ans ou plus
    2) Consentement écrit signé et daté avant toute procédure d'étude
    3) Première transplantation rénale
    4) Désireux et capable de participer à l'étude
    5) Les femmes en âge de procréer doivent utiliser une méthode de contraception appropriée pendant l'essai clinique (contraception orale, implant ou DIU) tout au long de la période d'étude et pendant 90 jours après la dernière dose de FR104. (voir les directives de l'EMA sur la section 2.2.2)
    6) Chaque femme en âge de procréer doit avoir un test de grossesse urinaire négatif le jour de la transplantation
    7) Tous les sujets masculins sexuellement actifs doivent accepter d'utiliser une méthode de contraception adéquate tout au long de la période d'étude et pendant 90 jours après la dernière dose de médicament d'étude et accepter de ne pas donner de sperme avant la fin de l'étude, ou pendant 90 jours après la dernière dose de FR104, selon ce qui est plus long
    8)Receveur d'un rein d'un donneur décédé
    9)Le receveur de la greffe doit être capable de suivre le traitement immunosuppresseur du protocole
    10)Temps d'ischémie froide < 36 heures
    11)Patients avec sécurité sociale française
    E.4Principal exclusion criteria
    1)Recipient of a kidney from living donor
    2)Patient at high immunological risk of rejection as determined for assessment of anti-donor reactivity:
    •High TGI >20%
    or
    •Presence of pre-formed DSA with MFI>500 (results 12 weeks prior to enrollment are acceptable if no blood transfusion or abortion occurred during this period)
    3)Any retransplantation and combined transplantations
    4)ABO incompatible transplantation
    5)HIV-positive, EBV-negative or suffering active viral hepatitis B (AgHbs positive excluded) or hepatitis C, syphilis serology- positive recipient
    6)CMV negative recipients of CMV positive donors (R-D+)
    7)Patient with known history of tuberculosis
    8)Uncontrolled concomitant infection or any other unstable medical condition (heart failure, severe liver disease, psychiatric disorders, substance abuse) that could interfere with the study objectives
    9)A known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components
    10)Previous history of cancer (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured)
    11)Pregnant woman or likely to become pregnant or nursing
    12)Patient under guardianship or trusteeship
    13)Patient participating in another interventional clinical trial
    14)Live viral or bacterial vaccines/treatment agents given from 3 months prior to FR104 administration (12 months for BCG vaccine)
    1)Receveur d'un rein d'un donneur vivant
    2)Patient au risque immunologique élevé de rejet avec un évaluation de la réactivité d'anti-donor :
    •TGI (Taux de Greffons Incompatibles)>20 % ou
    •La présence d'un DSA préformée avec MFI> 500 (les résultats 12 semaines avant l'inscription sont acceptables si aucune transfusion sanguine ou grossesse n'a pas eu lieu au cours de cette période).
    3)Toute retransplantation ou transplantations combines
    4)Greffe ABO incompatible
    5)Receveur , HIV positif, EBV-négatif ou avec une hépatite B active (AgHbs positif exclu) ou une hépatite C ou sérologie de la syphilis-bénéficiaire positive.
    6)Receveur CMV négatif et donneurs CMV positif (R-D+)
    7)Patient avec antécédent de Tuberculose connu.
    8)Infection concomitante incontrôlée ou toute autre condition médicale instable (insuffisance cardiaque, maladie hépatique grave, troubles psychiatriques, toxicomanie) qui pourrait interférer avec les objectifs de l'étude
    9)Présence d’une allergie, d’une hypersensibilité ou d’une intolérance connue au médicament de l'étude, ou à l'un de ses composants
    10)Antécédents de cancer (à l'exception d'un cancer de la peau non mélanome dûment traité ou d'un cancer du col de l'utérus localisé, ou d'autres tumeurs locales considérées comme guéries).
    11)Femme enceinte ou susceptible de devenir enceinte ou allaitante
    12)Patient sous tutelle ou curatelle.
    13)Patient participant à un autre essai clinique interventionnel.
    14)Aucun vaccin/traitement viral ou bactérien vivant ne devra être administré dans les 3 mois avant l'administration de FR104
    E.5 End points
    E.5.1Primary end point(s)
    Type, severity, number and percent of Adverse Events with a focus on infectious complications. In particular the following cumulative incidences will be calculated: Incidence of bacterial, fungal, viral, or parasitic infection, incidence of new malignancies, lymphopenia, anemia, leucopenia, cytopenia or biochemical disturbances related to the study drug.
    Type, gravité, nombre et pourcentage d'événements indésirables en mettant l'accent sur les complications infectieuses. En particulier, les incidences cumulatives suivantes seront calculées : Incidence de l'infection bactérienne, fongique, virale ou parasitaire. Incidence de nouvelles tumeurs malignes. Incidence de lymphopénie, d'anémie, de leucopénie, de cytopénie ou de perturbations biochimiques liées au médicament d'étude.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This evaluation will be done at each visit up to M12 with a special focus on relevant grades 3 and 4 adverse effects.
    Cette évaluation sera effectuée à chaque visite jusqu'à M12, en mettant l'accent sur les grades 3 et 4 pertinents.
    E.5.2Secondary end point(s)
    The efficacy of the treatment will be evaluated by:

    •Calculated glomerular filtration rate (CKD EPI) at each visit.
    •Acute cellular rejection seen on renal biopsy up for cause up to M12 (per Banff criteria 2017)
    •Graft acute rejection up to M12
    •Steroid resistant episodes up to M12
    •Rejection episodes up to M12
    •Chronic allograft nephropathy seen on renal biopsy for cause up to M12
    •Renal dialysis or new kidney transplant up to M12
    •Time to treatment failure up to M12 (BPAR, Graft Loss or Death)
    •Time to the first BPAR
    •Appearance of DSA
    •Long-term follow-up 1 year post-treatment to collect data (renal function, incidence of rejection, incidence of significant infections, incidence of new malignancies, occurrence of all suspected FR104 related adverse effects, patient survival and graft survival).
    L'efficacité du traitement sera évaluée par :

    •Calcul du taux de filtration glomérulaire (CKD EPI) à chaque visite
    •L’apparition de rejet cellulaire aigu observé lors d'une biopsie rénale pour cause dans les 12 mois post greffe (selon les critères de Banff 2017).
    •L’apparition de rejet Aigu du greffon apparu dans les 12 mois post greffe.
    •L’apparition de rejets résistants aux stéroïdes dans les 12 mois post greffe
    •L’apparition d’épisodes multiples de rejets jusqu'à 12 mois
    •L’apparition de Néphropathie chronique d'allogreffe observée lors d'une biopsie rénale pour cause dans les 12 mois post greffe.
    •Dialyse rénale ou retransplantation dans les 12 mois post greffe
    •Evaluation du délai d’échec de traitement dans les 12 mois post greffe (rejet, perte du greffon, décès)
    •Evaluation du délai d’apparition du premier rejet aigu prouvé par biopsie
    •Evaluation de l’apparition des DSA
    •Suivi à long terme (1 an après la fin du traitement) pour recueillir des données (fonction rénale, incidence des rejets, incidence des infections importantes, incidence des nouvelles malignités, apparition de tous les effets indésirables soupçonnés d'être liés au FR104, survie des patients et des greffons).
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Calculated glomerular filtration rate (CKD EPI) at each visit up to M24
    •Acute cellular rejection seen on renal biopsy for cause up to M12
    •Graft acute rejection up to M12
    •Steroid resistant episodes up to M12
    •Rejection episodes up to M12
    •Chronic allograft nephropathy seen on renal biopsy for cause up to M12
    •Renal dialysis or new kidney transplant up to M12
    •Time to treatment failure up to M14 (BPAR, Graft Loss or Death)
    •Time to the first BPAR
    •Appearance of DSA
    •Long-term follow-up at Year 2 post-transplantation
    •Calcul du taux de filtration glomérulaire (CKD EPI) à chaque visite jusqu'à M24
    •L’apparition de rejet cellulaire aigu dans les 12 mois post greffe
    •L’apparition de rejet Aigu du greffon apparu dans les 12 mois post greffe
    •L’apparition de rejets résistants aux stéroïdes dans les 12 mois post greffe
    •L’apparition d’épisodes multiples de rejets jusqu'à 12 mois
    •L’apparition de Néphropathie chronique d'allogreffe dans les 12 mois post greffe
    •Dialyse rénale ou retransplantation dans les 12 mois post greffe
    •Evaluation du délai d’échec de traitement dans les 12 mois post greffe (rejet, perte du greffon, décès)
    •Evaluation du délai d’apparition du premier rejet aigu prouvé par biopsie
    •Evaluation de l’apparition des DSA
    •Suivi à long-terme à 2 ans post-greffe
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration to renal transplant patient
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state10
    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)
    Normal treatment for this medical condition
    Traitement habituel à la condition médicale étudiée
    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 Decision2020-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
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