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    Summary
    EudraCT Number:2021-000835-30
    Sponsor's Protocol Code Number:MONET
    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:2021-08-30
    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 number2021-000835-30
    A.3Full title of the trial
    RESCUE THERAPY WITH THE HUMAN ANTI-CD38 ANTIBODY MOR202 (FELZARTAMAB) IN PATIENTS WITH MEMBRANOUS NEPHROPATHY WHO FAILED ANTI-CD20 TARGETED THERAPY: A PILOT, PROOF-OF-CONCEPT STUDY
    “Rescue therapy” con MOR202, un anticorpo anti-CD38, in pazienti con nefropatia membranosa resistenti alla terapia con anticorpi anti-CD20
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MOR202 for refractory MN
    Impiego di Felzartamab in pazienti con nefropatia membranosa resistenti alla terapia con anticorpi anti-CD20
    A.3.2Name or abbreviated title of the trial where available
    MOR202 for refractory MN
    MOR202 nella nefropatia membranosa resistente
    A.4.1Sponsor's protocol code numberMONET
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMorphoSys AG
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportIstituto di Ricerche Farmacologiche Mario Negri IRCCS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche Mario Negri IRCCS
    B.5.2Functional name of contact pointLab. Att. Regolatorie Studi Clinici
    B.5.3 Address:
    B.5.3.1Street Addressvia G.B. Camozzi, 3
    B.5.3.2Town/ cityRanica
    B.5.3.3Post code24020
    B.5.3.4CountryItaly
    B.5.4Telephone number0354535307
    B.5.5Fax number0354535372
    B.5.6E-mailpaola.boccardo@marionegri.it
    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 nameMOR202
    D.3.2Product code [MOR202]
    D.3.4Pharmaceutical form Lyophilisate for solution for 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.3.9.1CAS number 2197117-39-1
    D.3.9.2Current sponsor codeMOR202
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Membranous Nephropathy who Failed Anti-CD20 Target Therapy.
    Nefropatia membranosa resistente alla terapia con anti-CD20.
    E.1.1.1Medical condition in easily understood language
    Membranous Nephropathy who Failed Anti-CD20 Target Therapy.
    Nefropatia membranosa resistente alla terapia con anti-CD20.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10027170
    E.1.2Term Membranous nephropathy
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of MOR202 in reducing and/or abrogating urinary protein excretion in MN patients with nephrotic-range proteinuria who are resistant to or dependent from anti-CD20 antibodies.
    Valutare l’efficacia di MOR202 nel ridurre e/o eliminare l'escrezione urinaria di proteine nei pazienti affetti da NM con proteinuria nel range nefrosico resistenti o dipendenti dagli anticorpi anti-CD20.
    E.2.2Secondary objectives of the trial
    To assess, in MN patients with nephrotic-range proteinuria who are resistant to or dependent from anti-CD20 antibodies:
    - The clinical efficacy of MOR202 over the whole follow-up period.
    - The effect of MOR202 on anti-PLA2R and anti-THSD7A levels over time.
    - The incidence of immunological and clinical relapses after the MOR202-induced immunologic and/or clinical NS remission.
    - The effects of MOR202 on renal function, glomerular permselectivity and metabolic parameters over time.
    - The consequences of MOR202 administration on circulating NK-, T- and B-cell subsets.
    - The effects of MOR202 on patient-perceived outcomes.
    - The immunogenicity and pharmacokinetic profile of MOR202.
    - The safety of MOR202 administration.
    Valutare, in pazienti affetti da NM con proteinuria nel range nefrosico resistenti o dipendenti da anticorpi anti-CD20:
    - L’efficacia clinica di MOR202 durante tutto il periodo di follow-up.
    - L’effetto nel tempo di MOR202 sui livelli di anti-PLA2R e anti-THSD7A.
    - L'incidenza di recidive immunologiche e cliniche dopo la remissione immunologica e/o clinica di NS indotta da MOR202.
    - Gli effetti nel tempo di MOR202 sulla funzione renale, sulla permselettività glomerulare e sui parametri metabolici.
    - Le conseguenze della somministrazione di MOR202 sui sottogruppi di cellule NK, T e B circolanti.
    - Gli effetti di MOR202 sugli outcome percepiti dal paziente.
    - L'immunogenicità e il profilo farmacocinetico di MOR202.
    - La sicurezza della somministrazione di MOR202.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age =18 years.
    - Biopsy-proven membranous nephropathy with or without detectable circulating anti-PLA2R or anti-THSD7A antibodies.
    - Background treatment with RAS blocking agents (ACE inhibitor and/or ARBs), at maximum tolerated doses and adequately controlled blood pressure (BP <140/90 mmHg in at least three consecutive readings at screening).
    - One condition between:
    • Anti-CD20 Resistance: residual proteinuria =3.5 g/day (mean of three consecutive 24-hour urine collections), with less than 50% reduction compared to pre-treatment values at least 12 months after anti-CD20 antibody therapy.
    • Anti-CD20 Dependence: frequently relapsing NS (nephrotic-range proteinuria for >50% of time in the last five years or since disease onset, whichever is shorter) despite repeated treatments with anti-CD20 antibodies.
    - Estimated GFR >30 ml/min/1.73m2 (CKD-EPI equation) and less than 50% of sclerotic glomeruli in patients receiving renal biopsy.
    - A minimum 12-month wash-out from last anti-CD20 therapy with rituximab and/or other monoclonal antibodies.
    - No immunosuppressive therapy with steroid, cyclophosphamide, cyclosporine, mycophenolate mofetil or any other immunosuppressant over the last 6 months; in case of therapies administered for less than 2 weeks, no washout time will be required prior to inclusion.
    - Completed anti SARS Cov 2 Vaccination
    - Written informed consent
    - Età =18 anni;
    - Nefropatia membranosa confermata da biopsia con o senza anticorpi circolanti anti-PLA2R o anti-THSD7A rilevabili.
    - Terapia con agenti bloccanti RAS (ACE inibitori e/o ARB), alle dosi massime tollerate e pressione sanguigna adeguatamente controllata (PA <140/90 mmHg in almeno 3 letture consecutive allo screening).
    - Una delle seguenti condizioni:
    • Resistenza agli anti-CD20: proteinuria residua =3,5 g/die (media di 3 raccolte consecutive di urine nelle 24 ore), con una riduzione inferiore al 50% rispetto ai valori pre-trattamento ad almeno 12 mesi dalla terapia con anticorpi anti-CD20.
    • Dipendenza da anti-CD20: SN frequentemente recidivante (proteinuria nel range nefrosico per >50% del tempo negli ultimi 5 anni o dall'esordio della malattia, se insorta più recentemente), nonostante trattamenti ripetuti con anticorpi anti-CD20.
    - GFR stimata >30 ml/min/1.73m2 (calcolato con l’equazione CKD-EPI) e meno del 50% di glomeruli sclerotici (valutato nei pazienti sottoposti a biopsia renale).
    - Wash-out minimo di 12 mesi dall’ultima terapia anti-CD20 con rituximab e/o altri anticopri monoclonali.
    - Nessuna terapia immunosoppressiva con steroidi, ciclofosfamide,ciclosporina, micofenolato mofetil o altri farmaci immunosoppressori negli ultimi 6 mesi.; In caso di terapie somministrate per un periodo inferiore alle due settimane, non verrà richiesto nessun periodo di washout prima dell’inclusione nello studio
    - Ciclo vaccinale anti SARS Cov 2 completato
    - Consenso informato scritto.
    E.4Principal exclusion criteria
    - Clinically relevant neutropenia (neutrophils < 1.5 x 109/L), anemia (Hb levels <9.0 g/dL), thrombocytopenia (platelet count < 150.000/mm3), hypogammaglobulinemia (serum immunoglobulin =5.0 g/L), increased liver transaminase or bilirubin levels (total bilirubin, aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN).
    - Significant uncontrolled cardiovascular disease (including arterial or venous thrombotic or embolic events over the last three months) or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator.
    - Clinically relevant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening.
    - History of significant cerebrovascular disease (stroke or transitory ischemic attack over the last three months) or sensory or motor neuropathy of toxicity = grade 3.
    - Any clinical condition that in the investigator judgment could affect the possibility to complete the study or could have a major confounding effect on study findings and data interpretation.
    - Known intolerance to the study drug or its excipients
    - Any viral, bacterial or fungal infection without complete symptoms resolution from at least two weeks.
    - Serologic or virologic markers positive for HIV, hepatitis C (patients with positive antihepatitis C virus [anti-HCV] antibody but negative HCV RNA polymerase chain reaction [PCR] can enroll) or active or latent hepatitis B (patients with positive hepatitis B surface antigen [HBsAg] are excluded). Patients with isolated positive hepatitis B core antibody [anti-HBc], hepatitis B virus (HBV) DNA test by PCR must be non-detectable to enroll.
    - History of malignancy within the prior 5 years.
    - Participation in other clinical trials within 4 weeks of signing the consent form.
    - Expected need of anti SARS Cov 2 vaccination during the study period
    - Pregnancy or breast-feeding.
    - Childbearing potential in males and females non using an highly effective method of contraception according to 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf).
    - Legal incapacity or limited legal capacity.
    - Neutropenia clinicamente rilevante (neutrofili <1,5x109/L), anemia (livelli di Hb <9.0g/dL), trombocitopenia (conta piastrinica <150.000/mm3), ipogammaglobulinemia (immunoglobulina sierica =5.0g/L), transaminasi epatiche o livelli di bilirubina aumentati (bilirubina totale, aspartato transaminasi o alanina aminotransferasi >1.5xULN, fosfatasi alcalina >3.0xULN);
    - Malattia cardiovascolare non controllata importante a giudizio dello sperimentatore (compresi eventi trombotici o embolici arteriosi o venosi nei 3 mesi precedenti) o insufficienza cardiaca (di classe IV in accordo con la NYHA).
    - Anomalie clinicamente rilevabili sull’ECG), allo screening.
    - Storia di malattia cerebrovascolare importante (ictus o attacco ischemico transitorio negli ultimi 3 mesi), oppure di neuropatia sensoriale o motoria di tossicità = grado 3.
    - Qualsiasi condizione clinica che, a parere dello sperimentatore, possa condizionare la possibilità di completare lo studio o avere un significativo effetto confondente sui risultati dello studio e sulla interpretazione dei dati.
    - Intolleranza nota al farmaco sperimentale o ai suoi eccipienti
    - Qualsiasi infezione virale, batterica o fungina non completamente risolta da almeno due settimane
    - Marcatori sierologici e virologici positivi per HIV, epatite C (possono essere arruolati i pazienti positivi agli anticorpi contro l’epatite C [anti-HCV], ma negativi alla PCR per HCV RNA), oppure a epatite B attiva o latente (sono esclusi i pazienti positivi all’antigene di superficie dell’epatite B [HBsAg]). Per l’arruolamento di pazienti positivi all’anticorpo core dell’epatite B [anti-Hbc], il test per il DNA del virus dell’epatite B (HBV) mediante PCR deve risultare non rilevabile.
    - Storia di tumori maligni nei 5 anni precedenti.
    - Partecipazione ad altri studi clinici nelle 4 settimane precedenti alla firma del modulo di consenso.
    - Gravidanza o allattamento al seno.
    - Vaccinazione anti SARS CoV 2 programmata durante lo studio
    - Soggetti maschi e femmine in età fertile che non utilizzano un metodo contraccettivo ritenuto efficace secondo le Raccomandazioni CTFG del 2020 relative alla contraccezione e ai test di gravidanza negli studi clinici (accessibile all’indirizzo: https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf);
    - Incapacità legale o capacità legale limitata.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome
    - Reduction in 24-hour urinary protein excretion at 12 months after the first MOR202 administration compared to baseline.
    Co-primary Outcome
    - Composite endpoint of complete remission (24-hour urinary protein excretion <0.3 g or urinary protein to creatinine ratio < 300 mg/g, with serum albumin > 3.5 g/dL) or partial remission (24-hour urinary protein excretion <3.5 g or urinary protein to creatinine ratio < 3500 mg/g, with at least 50% reduction compared to baseline) of nephrotic syndrome at 12 months from the first infusion;
    Primari e Co-primari
    Valutare l’efficacia di MOR202 nel ridurre e/o eliminare l'escrezione urinaria di proteine nei pazienti affetti da NM con proteinuria nel range nefrosico resistenti o dipendenti dagli anticorpi anti-CD20.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At screening, basa, after 1, 4 and 24 months after the first IMP infusion visits.
    Alle visite di screening, basale, dopo 1, 4 e 24 mesi dalla prima somministrazione di farmaco.
    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 No
    E.6.5Efficacy No
    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 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 No
    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 trial1
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months0
    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 months0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    aaaaaa
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    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 Decision2021-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-12
    P. End of Trial
    P.End of Trial StatusOngoing
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