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    Summary
    EudraCT Number:2020-001537-13
    Sponsor's Protocol Code Number:ALXN1210-NEPH-202
    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:2021-06-08
    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 number2020-001537-13
    A.3Full title of the trial
    A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
    Studio di fase 2, in doppio cieco, randomizzato, controllato con placebo per valutare l'efficacia e la sicurezza di ravulizumab in partecipanti adulti con nefrite lupica (LN) proliferativa o nefropatia da immunoglobulina A (IgAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
    Studio con Ravulizumab in nefrite lupica (LN) o nefropatia da immunoglobulina A (IgAN)
    A.3.2Name or abbreviated title of the trial where available
    Ravulizumab in LN or IgAN
    Ravulizumab in LN or IgAN
    A.4.1Sponsor's protocol code numberALXN1210-NEPH-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04564339
    A.5.4Other Identifiers
    Name:INDNumber:148192
    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 SponsorALEXION PHARMACEUTICALS INCORPORATED
    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 supportAlexion Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexion Europe SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address103-105 rue Anatole France
    B.5.3.2Town/ cityLevallois-Perret
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number0033789973326
    B.5.5Fax number0033789973326
    B.5.6E-mailclinicaltrials.eu@alexion.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 Yes
    D.2.1.1.1Trade name Ultomiris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS EU/1/19/1371/001
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRavulizumab
    D.3.2Product code [ALXN1210]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRavulizumab
    D.3.9.1CAS number 1803171-55-2
    D.3.9.2Current sponsor codeALXN1210
    D.3.9.4EV Substance CodeSUB192773
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboConcentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus Nephritis (LN) - Immunoglobulin A Nephropathy (IgAN)
    Nefrite lupica (LN) e nefropatia da immunoglobulina A
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis (LN) - Immunoglobulin A Nephropathy (IgAN)
    Nefrite lupica (LN) e nefropatia da immunoglobulina A
    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 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021263
    E.1.2Term IgA nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy of ravulizumab compared with placebo in adult participants with LN and IgAN
    Valutare l'efficacia di ravulizumab rispetto al placebo per ridurre la proteinuria nei partecipanti adulti con LN o IgAN
    E.2.2Secondary objectives of the trial
    - Safety and tolerability of ravulizumab and additional efficacy measures
    - Valutare l'efficacia e la tollerabilità di ravulizumab e ulteriori valutazioni di efficacia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Common to both disease cohorts:
    - 18 - 75 years of age
    - Proteinuria = 1 (g/d or g/g)
    - Vaccinated against meningococcal infection
    - Vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae

    For LN cohort:
    - Diagnosis of active focal or diffuse proliferative LN Class III or IV
    - Clinical active LN, requiring/receiving immunosuppression induction treatment

    For IgAN cohort:
    - Diagnosis of primary IgAN
    - Compliance with stable and optimal dose of RAS inhibitor treatment for = 3 months
    In comune per entrambe le malattie
    - 18-75 anni
    - proteinuria = 1 (g/d or g/g)
    - vaccinati contro infezione meningococcica
    - vaccinati contro Haemophilus influenzae type b (Hib) e Streptococcus pneumoniae

    Per la coorte LN
    - diagnosi di LN proliferativa localizzata o diffusa di classe III e IV
    - LN clinicamente attiva, che richiede/sta già ricevendo trattamento con immunosoppressori

    Per la coorte IgAN
    - diagnosi di IgAn primaria
    - conformità con una ottimale e stabile dose di inibitori RAS per = 3 mesi
    E.4Principal exclusion criteria
    Common to both disease cohorts:
    - Estimated GFR < 30 mL/min/1.73 m2
    - Previously received a complement inhibitor (eg, eculizumab) at any time
    - Concomitant significant renal disease other than LN or IgAN
    - History of other solid organ or bone marrow transplant
    - Uncontrolled hypertension

    For IgAN cohort:
    - Diagnosis of rapid progressive glomerulonephritis
    - Prednisone or prednisone equivalent > 20 mg for > 14 consecutive days or any other immunosuppression within 6 months
    In comune per entrambe le malattie
    - GFR stimata < 30 mL/min/1.73 m2
    - ha ricevuto in precedenza un inibitore del complemento (ad es. eculizumab) in qualsiasi momento
    - malattia renale concomitante ed importante al di fuori di LN o IgAN
    - precedenti trapianti di organi solidi o di midollo osseo
    - ipertensione non controllata

    Per la coorte IgAN
    - diagnosi di glomerulonefrite a progressione rapida
    - Prednisone o farmaco equivalente > 20 mg per > 14 giorni consecutivi o qualsiasi altro immunosoppressore nei 6 mesi precedenti
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change in proteinuria from basal to week 26
    Variazione percentuale della proteinuria dal basale alla Settimana 26 (sulla base della raccolta delle urine delle 24 ore in ciascun punto temporale)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 26
    Dal basale alla settimana 26
    E.5.2Secondary end point(s)
    - Percentage change in proteinuria
    - Change from baseline in eGFR
    For LN:
    - Percentage of participants meeting the criteria for Complete Renal Response
    - Percentage of participants meeting the criteria for Partial Renal Response
    - Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g
    - Percentage of participants achieving corticosteroid taper to 7.5 mg/day
    - Percentage of participants with Renal Flare
    - Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare

    For IgAN:
    - Percentage of participants meeting the criteria for Partial Remission
    - Variazione percentuale della proteinuria dal basale alla Settimana 50 (sulla base della raccolta delle urine delle 24 ore in ciascun punto temporale)
    - Variazione dell'eGFR rispetto al basale alla Settimana 26 e alla Settimana 50

    Per LN
    - Percentuale di partecipanti che soddisfano i criteri per CRR alla Settimana 26 e alla Settimana 50
    - Percentuale di partecipanti che soddisfano i criteri per PRR alla Settimana 26 e alla Settimana 50
    - Tempo a UPCR <0,5 g/g misurato su campione di urina per dosaggio su spot
    - Percentuale di partecipanti che hanno raggiunto una riduzione graduale dei corticosteroidi a 7,5 mg/die alle Settimane 14, 26 e 50
    - Percentuale di partecipanti con riacutizzazione renale fino alla Settimana 50
    - Percentuale di partecipanti con riacutizzazione del LES extra renale fino alla Settimana 50

    Per IgAN
    - Percentuale di partecipanti che soddisfano i criteri per la remissione parziale alla Settimana 26 e alla Settimana 50
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout, Week 26 and/or Week 50
    Continuativo, e alla settimana 26 e/o 50.
    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 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
    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 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 EEA35
    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
    Canada
    Korea, Democratic People's Republic of
    Singapore
    Taiwan
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 41
    F.4.2.2In the whole clinical trial 120
    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)
    Ravulizumab will not be administered to participants after the end of the study. Upon completion of the last study visit, participants will return to the care of their treating physician.
    Ravulizumab non verrà somministrato ai partecipanti dopo la fine dello studio. Dopo il completamento dell'ultima visita, i partecipanti torneranno in cura presso i rispettivi medici.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NephroSynergy CRO, LLC
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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