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    Summary
    EudraCT Number:2022-002690-29
    Sponsor's Protocol Code Number:CVAY736F12302
    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:2022-10-28
    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 number2022-002690-29
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)
    Etude de phase 3 multicentrique, randomisée, en double aveugle, contrôlée versus placebo, évaluant l'efficacité, l’innocuité et la tolérance du ianalumab en association au traitement standard chez des patients atteints de lupus érythémateux systémique (SIRIUS-SLE2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 study to evaluate ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)
    Etude de phase 3 évaluant le ianalumab ajouté au traitement standard chez des patients atteints de lupus érythémateux systémique (SIRIUS-SLE 2)
    A.4.1Sponsor's protocol code numberCVAY736F12302
    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+33 1 5547 6600
    B.5.5Fax number+33 1 5547 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 in pre-filled syringe
    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.3.9.3Other descriptive nameVAY736
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus
    Lupus érythémateux systémique
    E.1.1.1Medical condition in easily understood language
    An inflammatory disease caused when the immune system attacks its own tissues.
    Maladie inflammatoire causée lorsque le système immunitaire attaque ses propres tissus.
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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 demonstrate superiority of subcutaneous (s.c.) ianalumab 300 mg monthly, compared to placebo, in achieving Systemic Lupus Erythematosus Responder Index (SRI-4) at Week 60
    Démontrer la supériorité du ianalumab 300 mg administré mensuellement par voie sous-cutanée (s.c.), par rapport au placebo, sur l’obtention d’une réponse SRI-4 (Systemic Lupus Erythematosus Responder Index) à la semaine 60
    E.2.2Secondary objectives of the trial
    To demonstrate superiority of s.c. ianalumab 300 mg monthly compared to placebo in: Reducing moderate or severe British Isles Lupus Assessment Group flares up to Week(Wk) 60; Maintaining corticosteroid dose ≤5 mg/day or ≤baseline dose, whichever is lower, b/w Wk 36 & Wk 60; Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Wk 60; Achieving Lupus Low Disease Activity State at Wk 60; Time to first occurrence of SRI-4 from baseline up to Wk 60; Achieving SRI-4 at Wk 60 while maintaining reduced corticosteroid dose ≤5 mg/day or ≤baseline dose, whichever is lower, b/w Wk 36 & Wk 60; Achieving SRI-6 at Wk 60; Maintaining corticosteroid dose ≤5mg/day or ≤baseline dose, whichever is lower, b/w Wk 24 & Wk 60

    To evaluate safety & tolerability of ianalumab 300 mg s.c. monthly

    To evaluate immunogenicity of ianalumab 300 mg s.c. monthly

    To characterize the PK of ianalumab 300 mg s.c monthly
    Démontrer la supériorité du ianalumab 300 mg administré mensuellement par voie sous-cutanée par rapport au placebo sur: Réduction des poussées modérées ou sévères selon le score BILAG (British Isles Lupus Assessment Group) jusqu'à la semaine 60; o Maintien de la dose de corticoïdes (CS) ≤ 5 mg/jour ou ≤ à la dose à la baseline, la valeur la plus basse prévalant, entre la semaine 36 et la semaine 60; o Atteinte de la réponse BICLA (BILAG-based Composite Lupus Assessment) à la semaine 60; o Atteinte du LLDAS (Lupus Low Disease Activity State) à la semaine 60; o Délai jusqu'à la première apparition d'une réponse SRI-4 de la baseline jusqu'à la semaine 60; o Atteinte d'une réponse SRI-4 à la semaine 60 avec le maintien d’une dose de CS réduite ≤ 5 mg/jour ou ≤ à la dose à la baseline, la valeur la plus basse prévalant, entre la semaine 36 et la semaine 60; o Atteinte d'une réponse SRI-6 à la semaine 60...
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and Female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed.

    Diagnosis of systemic lupus erythematosus (SLE) according to EULAR/ACR SLE classification criteria at least 6 months prior to screening

    Elevated serum titers at screening of Antinuclear Antibodies (≥1:80) as determined by a central laboratory with a SLE typical fluorescence pattern.

    Currently receiving corticosteroids and/or anti-malarial treatment and/or another Disease-modifying antirheumatic drug (DMARD) as specified in the protocol.

    SLEDAI-2K Criteria at screening: SLEDAI-2K score ≥6 points, excluding points attributed to “fever”, “lupus headache”, "alopecia", and “organic brain syndrome”
    British Isles Lupus Assessment Group-2004 disease activity level at screening of at least 1 of the following:
    British Isles Lupus Assessment Group-2004 level A disease in ≥1 organ system,
    Or
    British Isles Lupus Assessment Group-2004 level B disease in ≥2 organ systems

    Weigh at least 35 kg at screening
    Patients masculins et féminins âgés de 18 ans ou plus dans les pays de l'Espace Economique Européen et dans les autres pays où l'inclusion de patients de moins de 18 ans n'est pas autorisée.• Diagnostic de lupus érythémateux systémique selon les critères de classification du LES de l’ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) au moins 6 mois avant la sélection.
    Titres sériques d’anticorps anti-nucléaires (AAN) élevés ≥ 1:80 à la sélection avec un profil de fluorescence typique du LES et déterminés par un laboratoire centralisé.
    Patients sous corticothérapie (CS) et/ou traitement antipaludéen et/ou autre traitement antirhumatismal modificateur de la maladie (DMARD) tel qu’indiqué dans le protocole.• Critères SLEDAI-2K à la sélection : Score SLEDAI-2K ≥ 6 points, à l'exclusion des points attribués à « fièvre », « céphalée lupique », « alopécie » et « syndrome cérébral organique »
    Niveau d'activité BILAG-2004 de la maladie défini par au moins 1 des éléments suivants :
    o BILAG-2004 score A dans ≥ 1 système d’organe,
    Ou
    o BILAG-2004 score B dans ≥ 2 systèmes d’organe
    Poids d’au moins 35 kg à la sélection
    E.4Principal exclusion criteria
    Prior treatment with Ianalumab

    History of receiving following treatment I) high dose corticosteroids, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) 12 weeks prior to screening II) Cyclophosphamide or biologics such as immunoglobulins (i.v. or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cell activating factor-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) Any B-cell depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)

    Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization or history of recurrent clinically significant infection

    Chronic infection with hepatitis B (HBV) or hepatitis C (HCV)

    Evidence of active tuberculosis infection

    History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening

    Any one of the following laboratory values prior to randomization
    Platelets <25000/mm^3 (<25 x 10^3/μL)
    Hemoglobin (Hgb) <8.0 g/dL (<5 mmol/L), or <7.0 g/dL (<4.3 mmol/L) if related to participant's SLE such as in active hemolytic anemia
    Absolute neutrophil count (ANC) (<0.8 x 10^3/ μL)

    Severe organ dysfunction or life-threatening disease at screening

    History of major organ, hematopoietic stem cell or bone marrow transplant

    Presence of severe lupus kidney disease as defined by proteinuria above 2g/day or equivalent using spot urine protein creatinine ratio

    Receipt of live/attenuated vaccine within a 4-week period before first dosing

    Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms

    History of hypersensitivity to drugs of similar chemical class (e.g., IgG1 biologics) or oral
    CS or to any of the constituents of the study drugs (sucrose, L-histidine hydrochloride, Lhistidine,
    polysorbate 20)

    History of non-compliance with medical regimens or considered potentially unreliable

    Use of other investigational drugs within 5 half-lives of enrollment or within 30 days or
    until the expected pharmacodynamic effect has returned to baseline, whichever is longer,
    or longer if required by local regulations

    Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic corticosteroids

    History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer

    Pregnant or nursing (lactating) women.

    Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational drug.

    US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse while taking study treatment

    Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study
    Traitement antérieur par ianalumab
    Antécédents de traitements suivants
    o Corticoïdes à forte dose, inhibiteurs de la calcineurine, inhibiteurs de JAK ou autres inhibiteurs de kinases, ou autres DMARD (sauf ceux listés dans les critères d'inclusion) administrés dans les 12 semaines précédant la sélection
    o Cyclophosphamide ou agents biologiques tels que immunoglobulines (par voie intraveineuse ou sous-cutanée), plasmaphérèse, agents biologiques anti-récepteur de l'interféron de type I, anti-CD40, CTLA4-Fc Ig ou agents ciblant le facteur d'activation des lymphocytes B (BAFF) administrés dans les 24 semaines précédant la sélection ; belimumab administré dans les 12 semaines précédant la sélection
    o Tout traitement visant la déplétion des lymphocytes B, autre que le ianalumab, administré dans les 36 semaines précédant la randomisation ou tant que le nombre de lymphocytes B est inférieur à la limite inférieure de la normale ou à la valeur de baseline avant l’initiation du traitement visant la déplétion des lymphocytes B (la valeur la plus basse prévalant).
    Infections actives virales, bactériennes ou autres nécessitant un traitement systémique au moment de la sélection ou de la randomisation, ou antécédents d'infection récurrente cliniquement significative
    Infection chronique par le virus de l'hépatite B (VHB) ou de l'hépatite C (VHC).
    Signes de tuberculeuse active
    Antécédents d'immunodéficience primaire ou secondaire, y compris un résultat positif au dépistage du virus de l'immunodéficience humaine (VIH) à la sélection
    Présence d’une des valeurs biologiques anormales suivantes avant la randomisation :
    • Plaquettes < 25 000/mm3 (< 25 x 103/μL)
    • Hémoglobine (Hb) < 8,0 g/dL (< 5 mmol/L) ou < 7,0 g/dL (< 4,3 mmol/L) si liée au LES, comme en cas d’anémie hémolytique active
    • Nombre absolu de neutrophiles (NAN) (< 0.8 x 103/μL)
    Dysfonction sévère d'organe ou maladie engageant le pronostic vital à la sélection
    Présence d'une maladie lupique rénale sévère définie par une protéinurie supérieure à 2 g/jour ou équivalent d’après le rapport protéines/créatinine urinaires sur un échantillon urinaire
    Administration d’un vaccin vivant/atténué au cours des 4 semaines précédant la première administration
    Toute pathologie concomitante grave non contrôlée qui, de l'avis de l'investigateur, pourrait mettre le patient à risque du fait de sa participation ou perturber l'évaluation des symptômes liés au LES
    Affections autres que le lupus telles qu’asthme, goutte ou urticaire, nécessitant un traitement intermittent ou chronique par CS systémique
    Antécédents de cancer autre que carcinome basocellulaire localisé ou cancer in-situ du col utérin
    Femmes enceintes ou allaitant
    Femmes en mesure d’avoir des enfants, à savoir toute femme physiologiquement apte à être enceinte, sauf si elles utilisent des méthodes de contraception très efficaces pendant la durée de l’administration du traitement à l'étude et pendant 6 mois après l’arrêt du médicament à l’essai
    Pathologies chirurgicales, médicales, psychiatriques ou physiques qui, de l'avis de l'investigateur, risquent de compromettre la participation à cette étude
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving SRI-4 at Week 60
    Proportion de patients ayant obtenu une réponse SRI-4 à la semaine 60.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 60
    Semaine 60
    E.5.2Secondary end point(s)
    1. Proportion of participants with no moderate or severe British Isles Lupus Assessment Group flare up to Week 60

    2. Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower.

    3. Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 60

    4. Proportion of participants achieving Lupus Low Disease Activity State at Week 60

    5. Time to first occurrence of SRI-4 from baseline to Week 60
    6. Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower
    7. Proportion of participants achieving SRI-6 at Week 60
    8. Proportion of participants maintaining between Week 24 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day, or ≤baseline dose, whichever is lower

    Proportion of participants with AEs and SAEs

    Clinical laboratory measurements

    Vital Signs

    Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time

    Ianalumab concentration in serum during the treatment and follow-up (up to the end of study)
    1. Proportion de patients exempts de poussée modérée ou sévère selon le score BILAG jusqu’à la semaine 60

    2. Proportion de patients conservant entre la semaine 36 et la semaine 60 une dose réduite de predniso(lo)ne ≤ 5 mg/jour ou ≤ à la dose à la baseline, la valeur la plus basse prévalant

    3. Proportion de patients ayant atteint la réponse BICLA à la semaine 60.

    4. Proportion de patients ayant atteint le LLDAS à la semaine 60

    5. Délai jusqu'à la première apparition d'une réponse SRI-4 de la baseline à la semaine 60

    6. Proportion de patients ayant obtenu une réponse SRI-4 à la semaine 60 avec le maintien entre la semaine 36 et la semaine 60 d’une dose de predniso(lo)ne ≤ 5 mg/jour ou ≤ à la dose de la baseline, la valeur la plus basse prévalant

    7. Pourcentage de patients ayant obtenu une réponse SRI-6 à la semaine 60

    8. Proportion de patients conservant entre la semaine 24 et la semaine 60 une dose réduite de predniso(lo)ne ≤ 5 mg/jour, ou ≤ à la dose de la baseline, la valeur la plus basse prévalant

    Proportion de patients présentant des événements indésirables (EI) et des événements indésirables graves (EIG)

    Paramètres biologiques cliniques

    Signes vitaux

    Incidence et concentration sérique des anticorps anti-médicament (ianalumab) (ADA) au fil du temps

    Concentration sérique du ianalumab pendant les périodes de traitement et de suivi (jusqu'à la fin de l'étude)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,3,4,6,7 - Week 60

    2 - Between Week 36 and Week 60


    5 - from baseline to Week 60


    8 - Between Week 24 and Week 60
    1,3,4,6,7 - Semaine 60

    2 - entre la semaine 36 et la semaine 60

    5 - de la baseline à la semaine 60

    8 - entre la semaine 24 et la semaine 60
    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 Yes
    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
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Chile
    Colombia
    India
    Korea, Republic of
    Mexico
    Taiwan
    United States
    France
    Romania
    Germany
    Italy
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    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: 28
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 224
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 280
    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)
    Up to 2 year safety follow-up: Patients will be followed for at least 20 weeks (mandatory follow-up) or longer (conditional follow-up), until B cell recovery or up to 2 years after the end of treatment (EOT visit). In addition, the Investigator must provide follow-up medical care for all subjects, including subjects 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 Decision2023-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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