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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-005055-20
    Sponsor's Protocol Code Number:CVAY736A2103
    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:2021-11-10
    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 number2020-005055-20
    A.3Full title of the trial
    An open-label, non-randomized, biopsy-based mechanistic study on efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome
    Etude mécanistique en ouvert, non randomisée, basée sur l'analyse des biopsies, et portant sur l'efficacité, la pharmacocinétique, la pharmacodynamie, la sécurité d'emploi et la tolérance du ianalumab chez des patients atteints du syndrome de Sjögren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study with biopsy to investigate how ianalumab works in Sjögren`s and how safe it is
    Une étude clinique avec biopsie pour étudier comment l'ianalumab agit dans la maladie de Sjögren et à quel point il est sûr
    A.3.2Name or abbreviated title of the trial where available
    Biopsy-based mechanistic study
    A.4.1Sponsor's protocol code numberCVAY736A2103
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address8/10 rue Henry Sainte Claire Deville, CS 40150
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92563
    B.5.3.4CountryFrance
    B.5.4Telephone number+3315547 6600
    B.5.5Fax number+3315547 6100
    B.5.6E-mailicm.phfr@novartis.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 nameIanalumab
    D.3.2Product code VAY736
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIANALUMAB
    D.3.9.1CAS number 1929549-92-7
    D.3.9.2Current sponsor codeVAY736
    D.3.9.4EV Substance CodeSUB193896
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Sjögren's syndrome
    Syndrome de Sjögren
    E.1.1.1Medical condition in easily understood language
    Sjögren's syndrome
    Syndrome de Sjögren
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate changes in salivary gland histology after treatment with ianalumab
    Étudier les changements histopathologiques des glandes salivaires après traitement par ianalumab
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of ianalumab
    To characterize changes in salivary gland tissue by multimodal salivary gland ultrasound after treatment with ianalumab
    To assess the pharmacokinetics of ianalumab
    To assess the immunogenicity of ianalumab
    To investigate changes in salivary flow rate after treatment with ialanumab
    Évaluer la sécurité d’emploi et la tolérance du ianalumab ;
    Caractériser les changements du tissu des glandes salivaires par l’échographie multimodale des glandes salivaires après traitement par ianalumab ;
    Évaluer la pharmacocinétique (PK) du ianalumab ;
    Évaluer l'immunogénicité (IG) du ianalumab ;
    Étudier les changements du débit salivaire après traitement par ianalumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Classification of Sjögren's syndrome according to the 2016 ACR/EULAR criteria at screening.
    Historical labial minor salivary gland biopsy showing a focus score ≥1 Seropositive at screening for anti-Ro/SSA antibodies
    Screening EULAR Sjögren’s syndrome patient reported index (ESSPRI) score ≥ 5
    Syndrome de Sjögren primitif confirmé d'après les critères de classification ACR/EULAR 2016 à la sélection.
    Historique de biopsies de glandes salivaires labiales mineures montrant un focus score ≥ 1. Séropositivité pour les anticorps anti-Ro/anti-SSA à la selection
    Score ESSPRI ≥ 5 à la sélection.
    E.4Principal exclusion criteria
    - Presence of another autoimmune rheumatic disease that is active and constitutes the principle illness, specifically:
    - Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSPRI or ESSDAI
    - Active rheumatoid arthritis (RA) that impedes on the ability to
    score ESSPRI or ESSDAI
    Systemic sclerosis
    - Any other concurrent connective tissue disease (e.g., large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's syndrome assessment ESSPRI or ESSDAI.
    Prior use of ianalumab
    - Prior use of any B cell depleting therapy (e.g., rituximab or other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb within 1 year prior to dosing
    - B cell count <50 cells/μL
    - Current use of prednisone >10 mg/day [or equivalent other corticosteroid] or dose change within 2 weeks prior to dosing
    - Prior treatment with any of the following within 6 months of baseline: CTLA4-Fc Ig (abatacept), Anti-TNF-α mAb, intravenous Ig, plasmapheresis, i.v. or oral cyclophosphamide, i.v. or oral cyclosporine A.
    - patients taking either hydroxychloroquine more than 400 mg/day or methotrexate more than 25 mg weekly or leflunomide at not stable dose within 3 months prior to dosing. Patients who are taking the above mentioned drugs can be included if dose is within the mentioned limits and maintained at stable dose throughout the study
    - Active viral, bacterial or other infections that may require systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
    - Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect
    - For patients undergoing contrast ultrasound: known contraindication to SonoVue (sulphur hexafluoride microbubbles) ultrasound contrast agent
    - History of head and neck radiation therapy or of having received
    radioactive iodine
    - Présence d'une autre maladie rhumatismale auto-immune active et constituant la maladie principale, notamment :
    -Lupus érythémateux systémique actif modéré à sévère, avec positivité des anti-ADNdb et atteinte rénale, ou autre atteinte d'un organe compromettant l’évaluation des scores ESSPRI ou ESSDAI ;
    - Polyarthrite rhumatoïde (PR) active compromettant l’évaluation des scores ESSPRI ou ESSDAI ;
    Sclérodermie systémique;
    -Toute autre maladie concomitante du tissu conjonctif (par ex. vascularite des gros vaisseaux, syndrome de Sharp (maladie du collagène mixte)), active et nécessitant un traitement immunosuppresseur n'entrant pas dans le cadre de cet essai et susceptible de compromettre les évaluations des scores ESSPRI ou ESSDAI du syndrome de Sjögren.
    -Utilisation antérieure du ianalumab.
    -Utilisation antérieure de tout traitement induisant une déplétion des lymphocytes B (par ex. rituximab ou autres anticorps monoclonaux anti-CD20, anticorps monoclonaux anti-CD22 ou anticorps monoclonaux anti-CD52) au cours de l’année précédant l’administration du traitement.
    -Numération des lymphocytes B < 50 cellules/μL à la sélection.
    -Actuelle de prednisone > 10 mg/jour [ou d'un autre corticoïde équivalent] ou modification posologique dans les 2 semaines précédant l’administration du traitement.
    - Traitement antérieur par l’un des traitements suivants dans les 6 mois précédant la baseline :
    CTLA4-Fc Ig (abatacept) ;Anticorps monoclonal (AcM) anti-TNF-α ;. Ig par voie intraveineuse Plasmaphérèse ;Cyclophosphamide par voie intraveineuse ou orale ; Cyclosporine A par voie intraveineuse ou orale ; Patients prenant plus de 400 mg/jour d'hydroxychloroquine ou plus de 25 mg par semaine de méthotrexate ou de léflunomide à dose non stable dans les 3 mois précédant l'administration du traitement.
    - Infections actives virales, bactériennes ou autres susceptibles de nécessiter un traitement systémique au moment de la sélection ou de la baseline, ou antécédents d'infection récurrente cliniquement significative ou d'infections bactériennes avec des organismes encapsulés.
    - Utilisation régulière nécessaire de médicaments connus pour provoquer une sècheresse buccale/oculaire comme effet indésirable régulier et majeur.
    - Pour les patients subissant une échographie de contraste : contre-indication connue à l'agent de contraste échographique SonoVue (microbulles d'hexafluorure de soufre)
    - Antécédents de radiothérapie de la tête et du cou ou d’administration d'iode radioactif.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25
    (EOT)
    Changement par rapport à la ligne de base du logarithme des cellules B/B + T des glandes salivaires rapport à la semaine 25
    (fin d'étude)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 25
    Semaine 25
    E.5.2Secondary end point(s)
    1. Occurrence of treatment emergent adverse events (both serious and non-serious) during the study and occurrence of treatment emergent abnormal vital signs, laboratory and ECG data over the study period.
    2. Change from baseline in SGUS parameters over the study period
    3. Serum ianalumab concentrations during treatment and follow up. PK parameters AUClast, AUCinf, Cmax, Tmax, T1/2 and any other parameters as required
    4. Serum anti-ianalumab antibody (ADA assay) and incidence of ADA positive
    patients over the study period.
    5. Change from baseline in mean stimulated and unstimulated salivary flow rate changes over the study period.
    1. Survenance d'événements indésirables apparus sous traitement (à la fois graves et non graves) au cours de l'étude et survenue de signes vitaux anormaux, de données de laboratoire et d'ECG anormaux apparus sous traitement au cours de la période d'étude.
    2. Variation par rapport à la ligne de base des paramètres SGUS au cours de la période d'étude
    3. Concentrations sériques d'ianalumab pendant le traitement et le suivi. Paramètres PK AUClast, AUCinf, Cmax, Tmax, T1/2 et tout autre paramètre selon les besoins
    4. Anticorps sériques anti-ianalumab (test ADA) et incidence des ADA positifs
    patients au cours de la période d'étude.
    5. Variation par rapport à la ligne de base des variations du débit salivaire moyen stimulé et non stimulé au cours de la période d'étude.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Over the study period
    2. Over the study period
    3. During treatment and follow-up
    4. Over the study period
    5. Over the study period
    1. Au cours de la période d'étude
    2. Au cours de la période d'étude
    3. Pendant le traitement et le suivi
    4. Au cours de la période d'étude
    5. Au cours de la période d'étude
    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 No
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, immunogenicity
    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 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.8.2.4Number of treatment arms in the trial1
    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.8.5The 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 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
    LVLS
    DVDS
    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 months7
    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 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: 24
    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 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 state24
    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)
    Each subject will be required to complete the study in its entirety and thereafter no further study treatment will be made available to them.
    The investigator must provide follow-up medical care for all patients who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care
    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 Decision2022-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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