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    Summary
    EudraCT Number:2020-000727-40
    Sponsor's Protocol Code Number:230LE301
    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:2022-11-18
    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 number2020-000727-40
    A.3Full title of the trial
    A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
    Studio multicentrico in 2 parti, senza soluzione di continuità con Parte A (Fase 2)/Parte B (Fase 3), randomizzato, in doppio cieco, controllato con placebo, volto a valutare l’efficacia e la sicurezza di BIIB059 in partecipanti affetti da lupus eritematoso cutaneo subacuto e/o lupus eritematoso cutaneo cronico in fase attiva con o senza manifestazioni sistemiche e refrattari e/o intolleranti alla terapia antimalarica (AMETHYST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
    Uno studio per valutare l’efficacia e la sicurezza di BIIB059 in partecipanti affetti da lupus eritematoso cutaneo subacuto e/o lupus eritematoso cutaneo cronico in fase attiva con o senza manifestazioni sistemiche e refrattari e/o intolleranti alla terapia antimalarica.
    A.3.2Name or abbreviated title of the trial where available
    AMETHYST
    AMETHYST
    A.4.1Sponsor's protocol code number230LE301
    A.5.4Other Identifiers
    Name:INDNumber:135703
    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 SponsorBIOGEN IDEC RESEARCH LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailclinicaltrials@biogen.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 nameNot applicable
    D.3.2Product code [BIIB059]
    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 INNHA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM
    D.3.9.2Current sponsor codeBIIB059
    D.3.9.3Other descriptive nameHumanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
    D.3.9.4EV Substance CodeSUB208560
    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 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 Yes
    D.3.11.13.1Other medicinal product typerecombinant monoclonal antibody
    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
    Subacute Cutaneous Lupus Erythematosus
    Chronic Cutaneous Lupus Erythematosus
    lupus eritematoso cutaneo subacuto
    upus eritematoso cutaneo cronico
    E.1.1.1Medical condition in easily understood language
    Lupus
    Lupus
    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 10056509
    E.1.2Term Cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057903
    E.1.2Term Subacute cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057929
    E.1.2Term Chronic cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    The primary objectives of the study are to evaluate the efficacy of
    BIIB059 compared with placebo in reducing skin disease activity
    measured by the Cutaneous Lupus Activity of Physician's Global
    Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the
    Cutaneous Lupus Erythematosus Disease Area and Severity Index
    Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE
    and/or CCLE with or without systemic manifestations and refractory
    and/or intolerant to antimalarials.
    Gli obiettivi primari dello studio consistono nel valutare l’efficacia di BIIB059 rispetto al placebo nel ridurre l’attività della malattia cutanea misurata mediante il punteggio della Valutazione globale dello sperimentatore dell’attività del lupus cutaneo - versione modificata (CLA-IGA-R) [Parti A e B (Stati Uniti)] e il punteggio dell’Indice di area e gravità della malattia nel lupus eritematoso cutaneo relativo all’attività (CLASI-A) [Parte B (resto del mondo [ROW])] in partecipanti con LECS e/o LECC in fase attiva, con o senza manifestazioni sistemiche e refrattari e/o intolleranti agli antimalarici.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the efficacy of
    BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R,
    CLASI-A; to evaluate additional efficacy parameters of BIIB059 in
    reducing SCLE and/or CCLE disease activity; safety; tolerability; and
    immunogenicity of BIIB059 [Parts A and B].
    Gli obiettivi secondari dello studio consistono nel valutare l’efficacia di BIIB059 nel ridurre l’attività della malattia nel LECS e/o LECC mediante i punteggi CLA-IGA-R e CLASI-A; nel valutare ulteriori parametri di efficacia di BIIB059 nel ridurre l’attività della malattia nel LECS e/o LECC; nel valutare la sicurezza, la tollerabilità e l’immunogenicità di BIIB059 [Parti A e B].
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    1. Histologically confirmed (in the past or at Screening) diagnosis of CLE
    with or without systemic manifestations.
    2. Must have active cutaneous manifestations that meet study criteria.
    3. Must have a CLASI-A score =10.
    4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.
    Principali criteri di inclusione:
    1. Diagnosi di LEC confermata istologicamente (in passato o allo screening) con o senza manifestazioni sistemiche.
    2. Il soggetto deve presentare manifestazioni cutanee attive che soddisfino i criteri dello studio.
    3. Il soggetto deve presentare un punteggio CLASI-A =10.
    4. Il soggetto deve presentare una lesione LEC attiva nonostante un’adeguata sperimentazione del trattamento antimalarico.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    1. Any active skin conditions other than CLE that may interfere with the
    study assessments of CLE.
    2. Active severe lupus nephritis.
    3. Active neuropsychiatric SLE.
    4. Use of immunosuppressive or disease-modifying treatments for SLE or
    CLE [via an oral, intravenous (IV), or SC route] that were initiated less
    than 12 weeks prior to randomization, have not been at a stable and
    allowable dose.
    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
    Principali criteri di esclusione:
    1. Qualsiasi condizione cutanea attiva diversa dal LEC che possa interferire con le valutazioni del LEC previste dallo studio.
    2. Nefrite attiva grave da lupus.
    3. LES neuropsichiatrico attivo.
    4. Uso di trattamenti immunosoppressori o modificanti la malattia per il LES o il LEC [per via orale, endovenosa (EV) o SC] che sono stati iniziati meno di 12 settimane prima della randomizzazione e che non sono stati a una dose stabile e consentita.
    NOTA: sono applicabili altri criteri di esclusione/inclusione definiti dal protocollo
    E.5 End points
    E.5.1Primary end point(s)
    *Parts A (US+ROW) and B (US): Percentage of Participants who Achieve
    a Cutaneous Lupus Activity of Physician's Global Assessment-Revised
    (CLA-IGA-R) Erythema Score of 0 or 1
    * Part B (ROW): Percentage of Participants who Achieve Cutaneous
    Lupus Erythematosus Disease Area and Severity Index Activity Score
    (CLASI-70) Response, Defined as = 70% Decrease in CLASI-A Score
    From Baseline
    *Parti A (Stati Uniti+resto del mondo [ROW]) e B (Stati Uniti): percentuale di partecipanti che ottengono un punteggio di Valutazione globale dello sperimentatore dell’attività del lupus cutaneo - versione modificata (CLA-IGA-R) pari a 0 o 1.
    *Parte B (ROW): percentuale di partecipanti che ottengono una risposta secondo il punteggio dell’Indice di area e gravità della malattia nel lupus eritematoso cutaneo (CLASI-70). Risposta, definita come diminuzione = 70% del punteggio CLASSI-A da baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Parts A (US+ROW) and B (US): Week 16
    Part B (ROW): Baseline to Week 24
    Parti A (Stati Uniti+resto del mondo [ROW]) e B (Stati Uniti):): Settimana 16;
    Part B (ROW): dal baseline alla Settimana 24
    E.5.2Secondary end point(s)
    *Parts A and B (ROW): Percentage of Participants who Achieve a CLA-IGA-R Score of 0 or 1
    *Parts A and B (US): Percentage of Participants who Achieve a CLASI-70 Response
    *Part A: Percentage of Participants who Achieve a CLASI-50 Response
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a Score of 0 or 1 in the CLA-IGA-R Erythema Characteristic
    *Parts A and B (US and ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement in the 4 Morphological Characteristics Jointly
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a Score of 0 or 1 in the CLA-IGA-R Erythema Characteristic OR at Least 1 Level of Improvement in the 4 Morphological Characteristics Jointly
    *Parts A and B (US and ROW): Percentage of Participants who Achieve any Improvement in the Global Score of the CLA-IGA-R
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a CLASI-A Score 0 to 1
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a CLASI-A Score 0 to 3
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline CLASI-A Score
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A
    *Parts A and B (US and ROW): CLA-IGA-R Erythema Sub-Total Score
    *Parts A and B (US and ROW): CLA-IGA-R Scale-Hypertrophy Sub-Total Score
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a Score of 0 to 1 in CLASI-A Erythema sub-Total Score and in the Scale-Hypertrophy sub-Total Score
    *Parts A and B (US and ROW): Percentage of Participants who Achieve any Improvement in Nonscarring Alopecia and Hair Loss by a Measure of CLASI-A Subcomponents
    *Parts A and B (US and ROW): Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders who Receive BIIB059 During the DBPC Treatment Period at Weeks 16 [Part A/Part B(US)] and 24 [Part A/Part B(ROW)]
    *Parts A and B (US and ROW): Percentage of Participants With a CLA-IGA-R 0 to 1 Response Among Responders who Receive BIIB059 During the DBPC Treatment Period With a CLA-IGA-R Score of 0 to 1 at Weeks 16 [Part A/Part B(US)] and 24 [Part A/Part B(ROW)]
    *Parts A and B (US and ROW): Percentage of Participants With CLASI-70 Response Among CLASI-70 Nonresponders who Receive Placebo During the DBPC Treatment Period at Weeks 16 [Part A/Part B(US)] and 24 [Part A/Part B(ROW)]
    *Parts A and B (US and ROW): Percentage of Participants With a CLA-IGA-R 0 to1 Response Among CLA-IGA-R 0 to1 Nonresponders who Receive Placebo During the DBPC Treatment Period at Weeks 16 [Part A/Part B(US)] and 24 [Part A/Part B(ROW)]
    *Parts A&B(US+ROW): Annualized Mild and Moderate Safety of
    Estrogens in LE National Assessment-SLE Disease Activity Index Flare
    Index (SFI) Rate and Annualized Severe SFI Rate Through W24
    *Parts A and B (US and ROW): Annualized Mild and Moderate SELENA-SLEDAI Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Weeks 16, 24 and 52
    *Part A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score
    Parts A and B (US and ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    *Parts A and B (US and ROW): Number of Participants With Anti-BIIB059 Antibodies in Serum During the Duration of the Study
    *Part B (US and ROW): Percentage of Participants who Achieve CLA-IGA-R 0 to 1 in the Global Score
    *Part B (US and ROW): Absolute and Percent Change in CLASI-D
    *Part B (US and ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL)
    *Part B (US and ROW): Change From Baseline in Dermatology Life Quality Index (DLQI)
    *Part B (US and ROW): Impression of Change Items From Subject Global Assessment of Skin-Follow-up (SGA-Skin-FU)
    *Part B (US and ROW): Difference Between Global Assessment Items From Subject Global Assessment of Skin-Baseline (SGA-Skin-BL) at Baseline and the Same Items in SGA-Skin-FU
    *Parti A e B (ROW): Percentuale di partecipanti che raggiungono un punteggio CLA-IGA-R pari a 0 o 1
    *Parti A e B (Stati Uniti): percentuale di partecipanti che ottengono una risposta CLASI-70.
    *Parte A: percentuale di partecipanti che ottengono una risposta CLASI-50.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono un punteggio pari a 0 o 1 nella caratteristica dell’eritema dello strumento CLA-IGA-R.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono almeno 1 livello di miglioramento nelle 4 caratteristiche morfologiche congiuntamente.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono un punteggio pari a 0 o 1 nella caratteristica dell’eritema dello strumento CLA-IGA-R OPPURE almeno 1 livello di miglioramento nelle 4 caratteristiche morfologiche congiuntamente.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono un qualsiasi miglioramento nel punteggio CLA-IGA-R globale.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono un punteggio dell’Indice di area e gravità della malattia nel lupus eritematoso cutaneo relativo all’attività (CLASI-A) da 0 a 1.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono un punteggio CLASI-A da 0 a 3.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono una riduzione di 7 punti rispetto al punteggio CLASI-A basale.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono una riduzione del 50% nell’Indice CLASI-A.
    *Parti A e B (Stati Uniti e ROW): Percentuale di partecipanti che raggiungono una riduzione del 70% nel CLASI-A
    *Parti A e B (Stati Uniti e ROW): punteggio subtotale di eritema dello strumento CLA-IGA-R.
    *Parti A e B (Stati Uniti e ROW): punteggio subtotale di desquamazione/ipertrofia dello strumento CLA-IGA-R.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono un punteggio da 0 a 1 nel punteggio subtotale di eritema e nel punteggio subtotale di desquamazione/ipertrofia dello strumento CLASI-A.
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti che ottengono un qualsiasi miglioramento dell’alopecia non cicatrizzante e della perdita di capelli in base a una misura dei sottocomponenti CLASI-A.
    *Parti A e B (Stati Uniti e ROW): Percentuale di partecipanti con una risposta CLASI-70 tra i soggetti che ricevono BIIB059 durante il periodo di trattamento DBPC alle Settimane 16 [Parte A/Parte B(USA)] e 24 [Parte A/Parte B(ROW)]
    *Parti A e B (Stati Uniti e ROW): Percentuale di partecipanti con una risposta CLA-IGA-R da 0 a 1 tra i soggetti che ricevono BIIB059 durante il periodo di trattamento DBPC con un punteggio CLA-IGA-R da 0 a 1 alle Settimane 16 [Parte A/Parte B(USA)] e 24 [Parte A/Parte B(ROW)]
    *Parti A e B (Stati Uniti e ROW): percentuale di partecipanti con una risposta CLASI-70 tra i non rispondenti CLASI-70 che ricevono il placebo durante il periodo di trattamento DBPC alle Settimane 16 [Parte A/Parte B (Stati Uniti)] e 24 [Parte A/Parte B (ROW)].
    *Parti A&B (US+ROW): tasso annualizzato di sicurezza degli estrogeni lieve e moderato in LE National Assessment-SLE Disease Activity Index Flare Index (SFI) rate e tasso annualizzato di SFI grave fino a W24
    *Parti A e B (Stati Uniti e ROW): Percentuale di partecipanti con una risposta CLA-IGA-R da 0 a 1 tra i non rispondenti che ricevono placebo durante il periodo di trattamento DBPC alle Settimane 16 [Parte A/Parte B(USA)] e 24 [Parte A/Parte B(ROW)]
    *Parti A e B (Stati Uniti e ROW): Tasso annualizzato di un Indice di riacutizzazione SELENA-SLEDAI (SFI) e tasso annualizzato di SFI grave fino alle Settimane 16, 24 e 52
    *Parte A: Variazione rispetto al basale nel punteggio dell’indice di gravità e area della malattia del lupus eritematoso cutaneo relativo al danno (CLASI-D)
    Parti A e B (USA e ROW): numero di partecipanti che manifestano eventi avversi emergenti dal trattamento (TEAE) ed eventi avversi seri (SAE).
    *Parti A e B (Stati Uniti e ROW): Numero di partecipanti con anticorpi anti-BIIB059 nel siero durante la durata dello studio
    *Parte B (Stati Uniti e ROW): Percentuale di partecipanti che raggiungono la CLA-IGA-R da 0 a 1 nel punteggio globale
    *Parte B (Stati Uniti e ROW): variazione assoluta e percentuale nel punteggio CLASI-D.
    *Parte B (Stati Uniti e ROW): variazione rispetto al basale nel questionario relativo alla qualità della vita nel lupus eritematoso cutaneo (CLE-QoL).
    *Parte B (Stati Uniti e ROW): variazione rispetto al basale nell’Indice di qualità della vita in ambito dermatologico (DLQI).
    *Parte B (Stati Uniti e ROW): impressione di variazione delle voci dello strumento di Valutazione cutanea globale del soggetto - Follow-up (SGA-Skin-FU).
    *Parte B (Stati Uniti e ROW): differenza tra le voci di valutazione globale dello strumento di Valutazione cutanea globale del soggetto - Basale (SGA-Skin-BL) al basale e tra le stesse voci dello strumento SGA-Skin-FU.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to Week 16, Week 16, Up to Week 24, Week 24, Up to Week 52, Week
    52, Baseline up to Week 52, Up to Week 76
    Fino alla Settimana 16, Settimana 16, fino alla , Settimana 24, Settimana 24, fino a Settimana 52, Baseline fino a Settimana 52, fino a Settimana 76
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity and tolerability
    immunogenicità e tollerabilità
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Studio in 2 parti, senza soluzione di continuità
    A 2-part seamless design study
    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 trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Argentina
    Brazil
    Canada
    Chile
    China
    Colombia
    Japan
    Korea, Republic of
    Mexico
    Philippines
    Puerto Rico
    Saudi Arabia
    Taiwan
    United States
    France
    Poland
    Sweden
    Bulgaria
    Spain
    Switzerland
    Germany
    Italy
    Belgium
    Hungary
    Portugal
    Russian Federation
    Slovakia
    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
    The end of the study period (i.e., DBPC followed by ETP) is Week 52/EOS.
    La fine del periodo di studio (vale a dire, DBPC seguito da ETP) è la settimana 52/EOS.
    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 months2
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days29
    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: 464
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 474
    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)
    Participants who successfully stay in treatment up to Week 52 visit will be offered the opportunity to enroll in an open-label LTE study, which will be described in a separate protocol.
    Ai partecipanti che rimangono con successo in trattamento fino alla visita della settimana 52 verrà offerta l'opportunità di iscriversi a uno studio LTE in aperto, che sarà descritto in un protocollo separato.
    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 Decision2023-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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