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    Summary
    EudraCT Number:2020-003509-72
    Sponsor's Protocol Code Number:20200234
    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:2021-08-17
    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 number2020-003509-72
    A.3Full title of the trial
    A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
    Studio di fase 2b di dose-ranging per valutare l’efficacia e la sicurezza di efavaleukin alfa in soggetti con lupus eritematoso sistemico attivo con risposta inadeguata alla
    terapia standard
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus
    Efficacia e sicurezza di efavaleukin alfa in soggetti con lupus eritematoso sistemico attivo
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number20200234
    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 SponsorAMGEN INC.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@amgen.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 nameEfavaleukin Alfa
    D.3.2Product code [AMG 592]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNEFAVALEUKIN ALFA
    D.3.9.2Current sponsor codeAMG 592
    D.3.9.3Other descriptive nameRECOMBINANT FACTOR FC FUSION PROTEIN
    D.3.9.4EV Substance CodeSUB195522
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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/infusion
    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
    Active Systemic Lupus Erythematosus
    Lupus Eritematoso Sistemico attivo
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus
    Lupus Eritematoso Sistemico
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of efavaleukin alfa at week 52, as measured by the SRI-4 response
    Valutare l’efficacia di efavaleukin alfa alla settimana 52 in base alla risposta SRI-4
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of efavaleukin alfa at week 52, as measured by the BICLA index responses
    - Evaluate the efficacy of efavaleukin alfa at week 52, as measured by LLDAS response
    - Evaluate the efficacy of efavaleukin alfa at week 52, as measured by OCS tapering
    - Evaluate the efficacy of efavaleukin alfa at week 24, as measured by SRI-4 response
    - Evaluate the efficacy of efavaleukin alfa at week 24, as measured by the BICLA index responses
    - Evaluate the efficacy of efavaleukin alfa at weeks 24 and 52, as measured by hSLEDAI
    - Evaluate the efficacy of efavaleukin alfa on joints and skin
    - Evaluate the efficacy of efavaleukin alfa using BILAG score
    - Evaluate the efficacy of efavaleukin alfa using patient reported outcomes
    - Characterize the safety of efavaleukin alfa
    - Characterize the PK of efavaleukin alfa
    - Valutare l’efficacia di efavaleukin alfa alla settimana 52 in base alle risposte dell’indice BICLA
    - Valutare l’efficacia di efavaleukin alfa alla settimana 52 in base alla risposta LLDAS
    - Valutare l’efficacia di efavaleukin alfa alla settimana 52 in base alla riduzione graduale degli OCS
    - Valutare l’efficacia di efavaleukin alfa alla settimana 24 in base alla risposta SRI-4
    - Valutare l’efficacia di efavaleukin alfa alla settimana 24 in base alle risposte dell’indice BICLA
    - Valutare l’efficacia di efavaleukin alfa alle settimane 24 e 52 in base allo strumento hSLEDAI
    - Valutare l’efficacia di efavaleukin alfa sulle articolazioni e la cute
    - Valutare l’efficacia di efavaleukin alfa utilizzando il punteggio BILAG
    - Valutare l’efficacia di efavaleukin alfa utilizzando gli esiti riferiti dai pazienti
    - Caratterizzare la sicurezza di efavaleukin alfa
    - Caratterizzare la PK di efavaleukin alfa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject has provided informed consent prior to initiation of any study specific activities/procedures
    - Age >= 18 years to 75 years at screening
    - Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody >= 1:80 by immunofluorescence on Hep-2 cells being present at screening. AntidsDNA results based on the Phadia method will be used for SLE classification criteria and for the purposes of hSLEDAI scoring during screening and throughout the study
    - Hybrid SLEDAI score >= 6 points with a "Clinical" hSLEDAI score >= 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine and immunologic parameters. Including the following protocol specific rules: - Arthritis: for hSLEDAI scoring purposes, arthritis must involve small joints in the hands or wrists. - Alopecia: subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia >= 2. - Oral ulcers: ulcers location and appearance must be documented by the investigator. - Scleritis and episcleritis: the presence of stable SLE-related scleritis and episcleritis (ie, that will likely not require initiation/increase in immunosuppressants/immunomodulators as outlined in the inclusion/exclusion criteria) must be documented by an ophthalmologist and other causes excluded. - Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent) in a clean catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI >= 4. - Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI

    *Please refer to protocol for the full list
    - I soggetti hanno fornito il consenso informato prima di iniziare qualsiasi attività/procedura studio specifica
    - Età >=18 anni fino a 75 anni al momento dello screening
    - Soddisfare i criteri di classificazione del LES in accordo ai criteri di classificazione per il LES del 2019 dell'European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) con anticorpi antinucleo >=1:80 rilevati tramite immunofluorescenza su cellule Hep-2 allo screening. I risultati di AntidsDNA basati sul metodo Phadia vengono utilizzati per i criteri di classificazione del LES e ai fini del punteggio hSLEDAI durante lo screening e durante lo studio
    - Punteggio hSLEDAI >=6 punti con un punteggio hSLEDAI clinico >=4 punti. Il punteggio hSLEDAI "clinico" corrisponde alla valutazione del punteggio hSLEDAI senza l'inclusione di punti attribuibili ai risultati di laboratorio, inclusa l'urina e parametri immunologici. Comprese le seguenti regole protocollo specifiche: - Artrite: ai fini del punteggio hSLEDAI, l'artrite deve coinvolgere articolazioni piccole delle mani o dei polsi. - Alopecia: i soggetti devono presentare caduta dei capelli senza cicatrici; non devono presentare né alopecia areata né alopecia androgenetica; e dovrebbero avere un punteggio di attività CLASI per l'alopecia >= 2. - Ulcere orali: la posizione e l'aspetto delle ulcere devono essere documentate dall'investigatore. - Sclerite e episclerite: la presenza di sclerite ed episclerite stabile correlata al LES (cioè, che probabilmente non richiederanno inizio/aumento di immunosoppressori/immunomodulatori come delineati nei criteri di inclusione/esclusione) devono essere documentati da un oftalmologo e devono essere escluse altre cause. Renale: i soggetti con rapporto proteina dell'urina/creatinina <3000mg/g (o equivalente) in un campione pulito di urina possono essere arruolati e valutati nel hSLEDAI, e il soggetto ha un hSLEDAI clinico >= 4. - Pleurite e pericardite: sintomi
    di pleurite e pericardite devono essere accompagnati da riscontri oggettivi per essere valutati nel hSLEDAI.

    *Fare riferimento al protocollo per la lista completa
    E.4Principal exclusion criteria
    - Lupus nephritis with urine protein creatinine ratio > 3000 mg/g at screening or having required induction therapy within 1 year prior to screening.
    - Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
    Other Medical Conditions:
    - Currently present or within 1 year prior to screening a diagnosis of any inflammatory joint or skin disease other than SLE which would interfere with SLE disease assessment based on investigator judgement.
    - History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 4 months prior to screening.
    - Active infection for which anti-infectives were indicated within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.
    - Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.

    *Please refer to the protocol for the full list
    - Nefrite da lupus con rapporto di creatinina proteica urinaria> 3000 mg / g allo screening o che ha richiesto una terapia di induzione entro 1 anno prima dello screening.
    - Lupus attivo del SNC entro 1 anno prima dello screening inclusi, ma non limitati a, meningite asettica, atassia, vasculite del SNC, neuropatia cranica, sindrome demielinizzante, neurite ottica, psicosi, convulsioni o mielite trasversa.
    Altre condizioni mediche:
    - Diagnosi attualmente presente o entro 1 anno prima dello screening di qualsiasi malattia infiammatoria articolare o della pelle diversa dal LES che interferirebbe con la valutazione della malattia LES sulla base del giudizio dello sperimentatore.
    - Storia di qualsiasi malattia diversa dal LES che abbia richiesto un trattamento con corticosteroidi orali o parenterali per> 2 settimane entro 4 mesi prima dello screening.
    - Infezione attiva per la quale gli antinfettivi sono stati indicati entro 4 settimane prima della visita di screening OPPURE presenza di infezione grave, definita come la necessità di ricovero in ospedale o di antinfettivi per via endovenosa entro 8 settimane prima della visita di screening.
    - Tubercolosi attiva o tubercolosi latente senza anamnesi passata documentata di trattamento adeguato secondo lo standard di cura locale.

    *Fare riferimento al protocollo per la lista completa
    E.5 End points
    E.5.1Primary end point(s)
    SRI-4 response at week 52
    Risposta SRI-4 alla settimana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    E.5.2Secondary end point(s)
    - BICLA response at week 52
    - LLDAS response at week 52
    - Reduction of OCS to <= 7.5 mg/day by week 44 and sustained through week 52 in subjects with a baseline OCS dose = 10 mg/day
    - SRI-4 response at week 24
    - BICLA response at week 24
    - hSLEDAI response (ie, reduction >= 4 points from baseline) at week 24
    - hSLEDAI response (ie, reduction = 4 points from baseline) at week 52

    *Please refer to protocol for the full list
    - Risposta BICLA alla settimana 52
    - Risposta LLDAS alla settimana 52
    - Riduzione di OCS a <=7,5 mg/die entro la settimana 44 e mantenuta fino alla settimana 52 in soggetti con una dose al basale di OCS >=10 mg/die
    - Risposta SRI-4 alla settimana 24
    - Risposta BICLA alla settimana 24
    - Risposta hSLEDAI (ossia, riduzione >= 4 punti rispetto al basale) alla settimana 24
    - Risposta hSLEDAI (ossia, riduzione >= 4 punti rispetto al basale) alla settimana 52

    *Fare riferimento al protocollo per la lista completa
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 8, 12, 24, 36, and 52; Settimane 8, 12, 24, 36 e 52
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Canada
    Chile
    Colombia
    Hong Kong
    Japan
    Mexico
    Russian Federation
    Taiwan
    Turkey
    United States
    Austria
    Bulgaria
    France
    Italy
    Poland
    Switzerland
    Greece
    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
    Completion of follow-up
    Al completamento del follow-up
    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 months8
    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 months8
    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: 215
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 320
    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)
    6 week safety follow-up
    6 settimane di follow-up sulla sicurezza
    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 Decision2021-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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