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    Summary
    EudraCT Number:2020-001942-20
    Sponsor's Protocol Code Number:CCFZ533B2201E1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001942-20
    A.3Full title of the trial
    A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome
    Uno studio di estensione dello studio TWINSS per valutare sicurezza e tollerabilità di CFZ533 (iscalimab) a 2 diversi dosaggi somministrato per via sottocutanea in pazienti con Sindrome di Sjögren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety and tolerability of CFZ533 in patients with Sjögren's Syndrome
    Studio di sicurezza e tollerabilità di CFZ533 in pazienti con Sindrome di Sjögren
    A.3.2Name or abbreviated title of the trial where available
    Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome
    Studio di sicurezza e tollerabilità di CFZ533 in pazienti con Sindrome di Sjögren
    A.4.1Sponsor's protocol code numberCCFZ533B2201E1
    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 Farma S.p.A.
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio (VA)
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number0296541
    B.5.5Fax number029659066
    B.5.6E-mailinfo.studiclinici@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 nameiscalimab
    D.3.2Product code [CFZ533]
    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 INNISCALIMAB
    D.3.9.2Current sponsor codeCFZ533
    D.3.9.4EV Substance CodeSUB195512
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Sjögren’s Syndrome.
    Sindrome di Sjögren.
    E.1.1.1Medical condition in easily understood language
    Autoimmune condition of unknown cause where the body's own self-defenses attack glands that secrete fluids resulting in inflammation of the glands. The inflammatory process can involve other organs.
    Condizione autoimmune di causa sconosciuta in cui le autodifese del corpo attaccano le ghiandole, che secernono fluidi, con conseguente infiammazione delle stesse e di eventuali altri organi.
    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 evaluate the safety and tolerability of iscalimab at two dose levels (600 mg and 300 mg) in patients with Sjögren’s Syndrome, who participated in the TWINSS core study, CCFZ533B2201.
    Valutare la sicurezza e la tollerabilità di iscalimab a 2 diversi dosaggi (600mg e 300mg) in pazienti con Sindrome di Sjögren che hanno partecipato allo studio core TWINSS, CCFZ533B2201.
    E.2.2Secondary objectives of the trial
    1. To assess the pharmacokinetics (PK trough levels) and dose-exposure relationship of iscalimab;
    2. To assess immunogenicity of iscalimab.
    1. Valutare la farmacocinetica (livelli pre-somministrazione) e la relazione dose-esposizione di iscalimab;
    2. Valutare l’immunogenicità di iscalimab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants eligible for inclusion in this study must meet all of the following criteria:
    1. Participants must have participated in the TWINSS core study, CCFZ533B2201, and must have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60
    2. Signed informed consent must be obtained prior to participation in the extension study (i.e. before commencement of the Week 60 assessments of the core study)
    3. In the judgement of the Investigator, participants must be expected to clinically benefit from continued iscalimab therapy.
    I partecipanti eleggibili per l’inclusione in questo studio devono rispettare tutti i seguenti criteri:
    1. Devono aver partecipato allo studio core TWINSS, CCFZ533B2201, e devono aver completato tutto il periodo di trattamento fino alla settimana 48 e il periodo di follow-up fino alla settimana 60;
    2. Il consenso informato deve essere firmato prima della partecipazione allo studio di estensione (prima dell’inizio delle valutazioni dello studio core alla settimana 60);
    3. A giudizio dell’investigatore, è atteso per i partecipanti un beneficio clinico dalla terapia continuativa con iscalimab.
    E.4Principal exclusion criteria
    Participants meeting any of the following criteria are not eligible for inclusion in this study.
    1. Sjögren’s Syndrome overlap syndromes where another autoimmune rheumatic disease 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 ESSDAI domains
    • Active rheumatoid arthritis (RA) that impedes on the ability to score the ESSDAI articular domain
    • Systemic sclerosis
    • Any other concurrent connective tissue disease (e.g., lupus nephritis (LN), 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 organ domain assessments
    2. Use of other investigational drugs other than iscalimab during the core study
    3. Active uncontrolled viral, bacterial or other infections requiring systemic treatment at the time of enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
    4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test
    5. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 14 weeks after stopping of investigational drug.
    Highly effective contraception methods include:
    • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment
    • Male sterilization (at least 6 months prior to screening and confirmed as successful). For female patients in the study, the vasectomized male partner should be the sole partner for that patient. In case the vasectomized male partner is not the sole partner of the female patient, highly effective method of contraception must be applied
    (double barrier contraception is not sufficient)
    • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill
    for a minimum of 3 months before taking investigational drug.
    Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of
    the woman has been confirmed by follow up hormone level assessment she is considered not of childbearing potential.
    In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the Informed Consent Form (ICF).
    I partecipanti che presentino uno di questi criteri non sono eleggibili per l’inclusione in questo studio:
    1. Sindromi da overlap con la Sindrome di Sjögren, nella quale un’altra malattia autoimmune costituisce la malattia principale, ed in particolare:
    • Lupus Eritematoso Sistemico attivo di entità moderata-severa, con positività per anticorpi anti-dsDNA e coinvolgimento renale, o altro coinvolgimento d’organo che limiti la capacità di valutare lo score ESSDAI;
    • Artrite Reumatoide attiva, che limiti la capacità di valutare il dominio articolare dello score ESSDAI;
    • Sclerosi sistemica;
    • Qualunque altra connettivopatia (esempio: nefrite lupica, vasculite dei grossi vasi, Sindrome di Sharp – malattia mista del tessuto connettivo) che sia attiva e richieda terapia immunosoppressiva al di fuori degli scopi di questo studio, e che possa limitare la valutazione dei domini d’organo della Sindrome di Sjögren.
    2. Uso di altri farmaci sperimentali oltre ad iscalimab durante lo studio core.
    3. Infezioni virali o batteriche attive e non controllate, o altre infezioni che richiedano terapia sistemica al momento dell’arruolamento, o anamnesi positiva per infezioni ricorrenti clinicamente significative o di infezioni batteriche da organismi capsulati.
    4. Donne in gravidanza o allattamento, dove la gravidanza è definita come lo stato di una donna dopo il concepimento e fino al termine della gestazione, confermato dalla positività di un test di laboratorio per la gonadotropina corionica umana (hCG);
    5. Donne in età fertile, definite come donne che possono fisiologicamente iniziare una gravidanza, a meno che non stiano utilizzando metodi contraccettivi altamente efficaci durante il trattamento e nelle 14 settimane dopo il termine del trattamento sperimentale. Metodi contraccettivi ad alta efficacia includono:
    • Astinenza completa dai rapporti sessuali (se in coerenza con lo stile di vita abituale e preferito). L’astinenza periodica (ad esempio, da calendario, ovulatoria, sintotermico, metodi post-ovulatori) e il coito interrotto non sono considerati metodi contraccettivi accettabili;
    • Sterilizzazione femminile (precedente ooforectomia bilaterale chirurgica con o senza isterectomia), isterectomia totale o legatura delle tube almeno nelle sei settimane precedenti l’inizio della somministrazione del trattamento in studio. Nel caso di sola ooforectomia, lo stato riproduttivo deve essere confermato da una valutazione di follow-up del livello ormonale.
    • Sterilizzazione maschile (almeno 6 mesi prima dello screening e di successo confermato). Per le partecipanti donne dello studio, il partner maschile vasectomizzato deve essere l’unico partner. Se il partner vasectomizzato non fosse l’unico partner, deve essere utilizzato un metodo anticoncezionale ad alta efficacia.
    • Impiego di contraccezione ormonale per via orale (estrogeni e progesterone), o utilizzo di un dispositivo intrauterino (IUD) o di un sistema intrauterino (IUS) o di altre forme di contraccezione ormonale di efficacia comparabile (frequenza d’insuccesso < 1%), come ad esempio, anello ormonale vaginale o contraccezione ormonale transdermica. In caso di utilizzo della contraccezione ormonale orale questa deve mantenersi stabile per un minimo di 3 mesi prima dell’assunzione del trattamento in studio.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of Treatment-emergent adverse events (TEAEs)/ serious adverse events (SAEs);
    - Routine hematology and clinical chemistry laboratory test results at analysis visits up to end of study;
    - Vital signs at analysis visits up to end of study.
    - Incidenza di eventi avversi rilevanti ai fini del trattamento (TEAE)/ eventi avversi gravi (SAE);
    - Risultati dei test di laboratorio di ematologia e chimica clinica di routine durante le visite di analisi fino alla fine dello studio;
    - Segni vitali alle visite di analisi fino alla fine dello studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Repeatedly until study completion (60 weeks).
    Ripetutamente fino al completamento dello studio (60 settimane).
    E.5.2Secondary end point(s)
    1. Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods;
    2. Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study.
    1. Concentrazione libera di iscalimab nel plasma durante il trattamento (Ctrough) e il follow-up (fino alla fine dello studio);
    2. Incidenza di anticorpi anti-iscalimab nel plasma durante le visite di analisi fino alla fine dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Repeatedly until study completion (60 weeks).
    Ripetutamente fino al completamento dello studio (60 settimane).
    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 No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability and Immunogenicity.
    Tollerabilità e immunogenicità.
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Doppio cieco fino al Database Lock finale (DBL) dello studio Core (CFZ533B2201), aperto dopo DBL.
    Double-blind until final database lock (DBL) of Core study (CFZ533B2201), open after DBL.
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Turkey
    United States
    Austria
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Portugal
    Romania
    Slovenia
    Sweden
    United Kingdom
    Argentina
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial 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: 136
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 160
    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)
    Continuing care should be provided by investigator and/or referring physician.
    L'assistenza continuativa deve essere fornita dal ricercatore e/o dal medico curante.
    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 Decision2021-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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