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    Summary
    EudraCT Number:2022-003336-59
    Sponsor's Protocol Code Number:211038
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-04
    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 number2022-003336-59
    A.3Full title of the trial
    Efficacy and Safety of Obinutuzumab versus Rituximab in childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome :
    a double-blind multicenter randomized controlled study
    Efficacité et tolérance de l’obinutuzumab comparé au rituximab dans le syndrome néphrotique corticodépendant ou à rechutes fréquentes de l’enfant : essai multicentrique, randomisé controlé en double aveugle.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Obinutuzumab versus Rituximab in childhood Nephrotic Syndrome

    Efficacité et tolérance de l’obinutuzumab comparé au rituximab dans le syndrome néphrotique corticodépendant de l’enfant
    A.3.2Name or abbreviated title of the trial where available
    OBIRINS
    OBIRINS
    A.4.1Sponsor's protocol code number211038
    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 SponsorAPHP
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address1,Avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.4CountryFrance
    B.5.6E-mailfadila.amerali@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name RIXATHON® 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ GmbH
    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.3.4Pharmaceutical form Concentrate for 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 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 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 Yes
    D.2.1.1.1Trade name GAZYVARO® 1000 mg/40 mL
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical form Concentrate for 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic nephrotic syndrome (INS)
    Le syndrome néphrotique idiopathique
    E.1.1.1Medical condition in easily understood language
    glomerulopathy
    néphropathies
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the superiority of one infusion of obinutuzumab compared to one infusion of rituximab on the relapse-free survival at 12-months.
    Evaluer la supériorité d’une perfusion d’OBI comparée à une perfusion de RTX sur la survie sans rechute à 12 mois.
    E.2.2Secondary objectives of the trial
    1.To assess the superiority of obinutuzumab compared to rituximab on the relapse-free survival at 24-months
    2. To compare the duration of B-cell depletion after OBI and RTX
    3. To compare the relapse-free survival after B-cell recovery after OBI and RTX
    4. To compare the number of relapses, steroid courses and second line treatment strategies required within 24 months in both arms
    5. To compare the safety of the two treatments including infusion-related reactions, infections, levels of immunoglobulins, neutropenia
    6. To assess the factors associated with sustained remission
    7. To assess the cost-effectiveness of the OBI strategy
    8. To assess the budgetary impact of the generalization of the OBI strategy
    9. To assess pharmacokinetics of Obinutuzumab and Rituximab
    10. To assess the development of antidrug antibodies
    1.Evaluer la supériorité d’une perfusion d’OBI comparée à une perfusion de RTX sur la survie sans rechute à 24 mois
    2.Comparer la durée de déplétion B après OBI et RTX
    3.Comparer la survie sans rechute après la réplétion B après OBI et RTX
    4.Comparer le nombre de rechute, les traitements corticoides et immunosuppresseurs nécessaires dans les 2 bras
    5.Comparer la tolérance des 2 traitements, incluant les reactions liées à l’infusion, infections, neutropénies et effets sur le niveau d’immunoglobulines
    6.Evaluer les facteurs associés au maintien en rémission
    7.Evaluer le rapport côut-efficacité de la stratégie de traitement avec l’OBI
    8.Evaluer l’impact budgétaire de la généralisation du traitement par OBI
    9.Evaluer la pharmacocinetique de l’OBI et du RTX.
    10.Evaluer le développement des auto-anticorps anti-médicament.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age between 3 and 18 years
    -Steroid dependant Nephrotique Syndrome defined as:
    •2 or more relapses during steroids or within 2 weeks following discontinuation.
    •2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal
    OR Frequent Relapsing Nephrotic Syndrome defined as:
    • 2 or more relapses within 6 months following first remission
    • 3 or more relapses within any 12-month period
    - Last relapse within 3 months prior to inclusion
    - In remission, defined as 3 consecutive urinary dipsticks without proteinuria, at the time of randomization
    - Vaccination schedule in accordance with the current recommendations in France
    -Informed consent from parents
    -age entre 3 à 18 ans
    -Syndrome Nephrotique Corticodépendant définie par :
    •Au moins 2 rechutes sous corticoïdes ou dans les 2 semaines qui suivent l’arrêt
    •Ou au moins 2 rechutes, dont une sous immunosuppresseur oral (MMF, anticacineurine, cyclophosphamide, levamisole) ou dans les 6 mois qui suivent l’arrêt
    OU
    Rechutes fréquentes définies par :
    •au moins 2 rechutes dans les 6 mois suivant la première rémission
    •au moins 3 rechutes sur toute période de 12 mois
    -Dernière rechute dans les 3 mois précédent l’inclusion
    -En rémission, définie une bandelette urinaire négative 3 jours consécutifs
    -Vaccination à jour selon les recommandations en France
    -Signature du consentement éclairé par les 2 parents ou par le titulaire de l’autorité parentale
    E.4Principal exclusion criteria
    Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
    -Primary or secondary steroid resistance nephrotic syndrome
    -Prior treatment with Rituximab within 6 months
    -Prior treatment with obinutuzumab at any time
    -CD20+ B-cell count < 2.5%
    -Patient with neutrophils < 1.5 G/L and/or platelets < 75 G/L
    - GFR < 80 ml/min/1.73m2
    - Weight <16kg
    -History of severe infection such as tuberculosis, hepatitis B, hepatitis C or HIV infection or LEMP
    - History of malignancy- Uncontrolled infection (viral, bacterial and fungal)
    - Vaccination with a live vaccine within 4 weeks prior to assignment/randomization
    - Known hyperprolinemia
    - Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients
    -Pregnancy or breastfeeding or ability to become pregnant and refusal to use effective contraception during the 18 months following the study treatment (only 1 infusion of obinutuzumab/Rituximab at the beginning of the study)
    -Patient without medical insurance coverag
    - Cause secondaire du syndrome néphrotique (comme la néphropathie membraneuse, la néphropathie à IgA, la néphrite lupique)
    - Syndrome néphrotique corticorésistant primaire ou secondaire.
    - Traitement par rituximab dans les 6 derniers mois
    - Traitement antérieur par Obinutuzumab à tout moment
    - Compte des Lymphocytes B CD20 < 2.5 %
    - Compte des polynucléaires neutrophiles <1500/mm3 ou des plaquettes < 75G/L
    - GFR < 80ml/min/1.73m2
    - Poids < 16 kg
    - Histoire médicale d’infection sévère comme la tuberculose, l’hépatite B, l’hépatite C, le VIH ou LEMP
    - Antécédents de malignité - Infection non contrôlée (virale, bactérienne et fongique)
    - Vaccin vivant réalisé dans les 4 semaines précédant la randomisation
    - Allergie ou contre-indication au rituximab ou à l’obinutuzumab ou à l’un de leur excipients
    - Hyperprolinémie connue
    - Patientes en âge de procréer refusant une contraception pendant les 18 mois suivant la prise du traitement de la recherche (une seule perfusion de obinutuzumab/Rituximab en début de leur participation à cette recherche)
    - Femmes enceintes ou désireuse de l’être ou allaitantes
    - Patient ne bénéficiant pas d’un régime de protection sociale ou ayant droit (hors AME)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the occurrence of a relapse defined as a 3+ proteinuria on dipstick on 3 consecutive days, with 1 laboratory urine dosage of Protein-over-creatinine ratio > 0.20g/mmol (> 0.2g/g), within 12 months following the initiation of Treatment
    Survenue d’une rechute au cours des 12 mois suivant la perfusion, la rechute étant définie par une protéinurie à 3+ à la bandelette urinaire pendant 3 jours consécutifs associée à un dosage au laboratoire du rapport protéinurie/créatininurie > 0.20g/mmol (> 0.2 g/g).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 month
    12 mois
    E.5.2Secondary end point(s)
    1.To assess the superiority of obinutuzumab compared to rituximab on the relapse-free survival at 24-months
    2. To compare the duration of B-cell depletion after OBI and RTX
    3. To compare the relapse-free survival after B-cell recovery after OBI and RTX
    4. To compare the number of relapses, steroid courses and second line treatment strategies required within 24 months in both arms
    5. To compare the safety of the two treatments including infusion-related reactions, infections, levels of immunoglobulins, neutropenia
    6. To assess the factors associated with sustained remission
    7. To assess the cost-effectiveness of the OBI strategy
    8. To assess the budgetary impact of the generalization of the OBI strategy
    9. To assess pharmacokinetics of Obinutuzumab and Rituximab
    10. To assess the development of antidrug antibodies
    1. Evaluer la supériorité d’une perfusion d’OBI comparée à une perfusion de RTX sur la survie sans rechute à 24 mois
    2. Comparer la durée de déplétion B après OBI et RTX
    3. Comparer la survie sans rechute après la réplétion B après OBI et RTX
    4. Comparer le nombre de rechute, les traitements corticoides et immunosuppresseurs nécessaires dans les 2 bras
    5. Comparer la tolérance des 2 traitements, incluant les reactions liées à l’infusion, infections, neutropénies et effets sur le niveau d’immunoglobulines
    6. Evaluer les facteurs associés au maintien en rémission
    7. Evaluer le rapport côut-efficacité de la stratégie de traitement avec l’OBI
    8. Evaluer l’impact budgétaire de la généralisation du traitement par OBI
    9. Evaluer la pharmacocinetique de l’OBI et du RTX.
    10. Evaluer le développement des auto-anticorps anti-médicament.
    OBIRINS est un essai prospectif multicentrique de supériorité, randomisé, contrôlé, en double-aveugle contre un comparateur actif (2 bras parallèles 1 :1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 month
    24 mois
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned13
    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 dernier patient
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 88
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 44
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 44
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state88
    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 Decision2023-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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