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    Summary
    EudraCT Number:2019-000780-24
    Sponsor's Protocol Code Number:MOR202C103
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-07-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-000780-24
    A.3Full title of the trial
    A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE
    Ensayo clínico en fase Ib/IIa, abierto y multicéntrico para evaluar la seguridad y la eficacia del anticuerpo humano anti-CD38 MOR202 en la nefropatía membranosa (NM) positiva para anticuerpos anti-PLA2R – M-PLACE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy
    Ensayo clínico abierto para evaluar la seguridad y eficacia de MOR202 en la nefropatía membranosa
    A.4.1Sponsor's protocol code numberMOR202C103
    A.5.4Other Identifiers
    Name:IND NumberNumber:142840
    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 SponsorMorphoSys AG
    B.1.3.4CountryGermany
    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 supportMorphoSys AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMorphoSys AG
    B.5.2Functional name of contact pointSenior Global Program Medical Direc
    B.5.3 Address:
    B.5.3.1Street AddressSemmelweisstrasse 7
    B.5.3.2Town/ cityPlanegg
    B.5.3.3Post codeD-82152
    B.5.3.4CountryGermany
    B.5.4Telephone number+3495701 04 40
    B.5.5Fax number+498989927 526640
    B.5.6E-mailinfo@morphosys.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 nameMOR202
    D.3.2Product code MOR202
    D.3.4Pharmaceutical form Powder for concentrate 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.3.8INN - Proposed INNNo INN assigned yet
    D.3.9.1CAS number 2197112-39-1
    D.3.9.2Current sponsor codeMOR202
    D.3.9.3Other descriptive nameMOR03087
    D.3.9.4EV Substance CodeSUB32212
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number65
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal anti-CD38 antibody
    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
    Primary (anti-PLA2R antibody positive) Membranous Nephropathy
    Primario (anticuerpo anti-PLA2R positivo) membranosa nefropatía
    E.1.1.1Medical condition in easily understood language
    Membranous Nephropathy (a condition of the kidneys).
    Nefropatía membranosa (una condición de los riñones).
    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 10027170
    E.1.2Term Membranous nephropathy
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of MOR202 treatment in subjects with anti-PLA2R antibody positive membranous nephropathy (aMN)
    Evaluar la seguridad y la tolerabilidad del tratamiento con MOR202 en sujetos con nefropatía membranosa positiva al anticuerpo anti-PLA2R (aMN)
    E.2.2Secondary objectives of the trial
    To assess the effect of MOR202 on serum anti-PLA2R antibodies in subjects with aMN
    To assess immunogenicity of MOR202 (anti-MOR202 antibody formation)
    To assess the pharmacokinetic (PK) profile of MOR202
    To assess safety in the follow-up phase
    Evaluar el efecto de MOR202 sobre los anticuerpos séricos anti-PLA2R en sujetos con NM
    Para evaluar la inmunogenicidad de MOR202 (formación de anticuerpos anti-MOR202)
    Para evaluar el perfil farmacocinético (FC) de MOR202
    Evaluar la seguridad en la fase de seguimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥18 to ≤80 years (at date of signing ICF)
    2. Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g (as measured from a 24 hour urine collection)
    3. MN diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
    4. Estimated glomerular filtration rate (eGFR) ≥50 ml/min/1.73m² or >30 and <50 ml/min/1.73m², and IFTA (interstitial fibrosis and tub-ular atrophy) score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening. If a subject falls into the latter range without availability of an adequate biopsy, a biopsy at screening should be performed for IFTA assessment.
    5. The subject is on supportive treatment with an ACEI or an ARB for at least 4 weeks prior to screening. The ACEI or ARB treatment should have reached a stable dose according to best local practice.
    6. Systolic BP ≤ 150 mmHg and diastolic BP ≤ 100 mmHg after a period of 5 minutes of rest as measured at screening
    7. Subject vaccinated against Pneumococcus within the last 3 years prior to date of signing ICF (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days (1)).
    8. Cohort 1: Serum anti-PLA2R antibodies ≥ 150.0 RU/mL as determined at screening by Euroimmun ELISA
    9. Cohort 1: Serum anti-PLA2R antibodies before screening ris-ing or stable as judged by the investigator
    10. Cohort 1, relapse subjects only: Must have had complete remission of proteinuria, or a combination of partial remission of proteinuria (demonstrating at least 50 % decrease) with a remission of serum anti-PLA2R anti-body titer to less than 20.0 RU/mL (Euroimmun ELISA) or negative Immunfluorescence Test (IFT). Remission must have lasted for at least 6 months according to clinical judgement.
    11. Cohort 2: Failure of previous therapy, i.e. subject never achieved a reduction of serum anti-PLA2R antibody titers to below 20.0 RU/ml (Euroimmun ELISA) during or after completion of a recognized IST contain-ing CSA, tacrolimus, MMF, ACTH or alkylating agents (e.g. cy-clophosphamide), or RTX determined after at least 6 months after start of this IST.
    12. Cohort 2: Subjects may have received a maximum of two prior treatment lines of immunosuppressive therapy (retreatment for re-lapse with the same regimen is considered a line of its own). A planned, fixed sequence of different therapeutic agents (e. g. STARMEN regimen) is considered as one regimen.
    1. ≥18 a ≤80 años de edad (en la fecha de la firma del FCI).
    2. Cociente proteína/creatinina (P/C) en orina de ≥3,0 g/g (medido a partir de una recogida de orina de 24 horas).
    3. NM diagnosticada en base a una biopsia; se acepta una biopsia de archivo obtenida en los 5 años previos a la selección.
    4. Tasa de filtración glomerular estimada (TFGe) ≥50 ml/min/1,73 m² o >30 y <50 ml/min/1,73 m², y una puntua-ción FIAT (fibrosis intersticial y atrofia tubular) de menos del 25 % en una biopsia renal obtenida en los 6 meses anteriores al inicio de la selección. Si un sujeto se encuentra en este último intervalo sin disponibilidad de una biopsia adecuada, se deberá realizar una biopsia en la selección para la evaluación FIAT.
    5. El sujeto recibe tratamiento de apoyo con un IECA o un BRA durante al menos 4 semanas antes de la selección. El tratamiento con IECA o BRA debe haber alcanzado una dosis estable según la mejor práctica local.
    6. TA sistólica ≤150 mmHg y TA diastólica ≤100 mmHg tras un periodo de 5 minutos de reposo, según la medición realizada en la selección.
    7. Paciente vacunado contra neumococo en los 3 años previos a la fecha de la firma del FCI (los sujetos pueden ser vacunados du-rante la selección para cumplir este criterio; el intervalo de tiem-po hasta la primera dosis de MOR202 debe ser de al menos 14 días) (1).
    8. Cohorte 1: Anticuerpos anti-PLA2R en suero ≥150,0 UR/ml se-gún lo determinado en la selección mediante Euroimmun ELI-SA.
    9. Cohorte 1: Anticuerpos anti-PLA2R en suero antes de la selec-ción en aumento o estables, según el criterio del investigador.
    10. Cohorte 1, solo sujetos en recidiva: Debe haber tenido una remi-sión completa de la proteinuria o una combinación de remisión parcial de la proteinuria (que demuestre por lo menos una reduc-ción del 50 %) con una remisión del título de anticuerpos anti-PLA2R en suero a menos de 20,0 UR/ml (Euroimmun ELISA) o un resultado negativo de la prueba de inmunofluorescencia (PIF). La remisión debe haber durado al menos 6 meses de conformidad con el juicio clínico.
    11. Cohorte 2: Fracaso del tratamiento anterior, es decir, el sujeto nunca logró una reducción de los títulos de anticuerpos anti-PLA2R en suero por debajo de 20,0 UR/ml (Euroimmun ELISA) durante o después de la finalización de un TID reconocido que contuviera CSA, tacrolimús, MMF, ACTH o agentes alquilantes (p. ej., ciclofosfamida) o RTX, según se determinó después de al menos 6 meses desde del inicio de este TID.
    12. Cohorte 2: Los sujetos pueden haber recibido un máximo de dos líneas de tratamiento previas de tratamiento inmunodepresor (la repetición del tratamiento para la recidiva con la misma pauta se considera una línea de tratamiento). Una secuencia fija y planifi-cada de distintos agentes terapéuticos (p. ej., pauta STAR-MEN)(2) se considera como una pauta.
    E.4Principal exclusion criteria
    1. Hemoglobin < 90 g/L
    2. Thrombocytopenia: Platelets < 100.0x10^9/L
    3. Neutropenia: Neutrophils < 1.5x10^9/L
    4. Leukopenia: Leukocytes < 3.0x10^9/L
    5. Hypogammaglobulinemia: Serum immunoglobulins ≤5.0 g/L
    6. Secondary cause of MN (e.g. SLE, medications, malignancies) as determined by the investigator
    7. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy)
    1. Hemoglobina <90 g/l
    2. Trombocitopenia: Plaquetas <100,0 × 109/l
    3. Neutropenia: Neutrófilos <1,5 x 109/l
    4. Leucopenia: Leucocitos <3,0 x 109/l
    5. Hipogammaglobulinemia: Inmunoglobulinas séricas ≤5,0 g/l
    6. Causa secundaria de NM (p. ej., LES, medicamentos, neoplasias malignas) según lo determinado por el investigador
    7. Enfermedad renal concomitante, aparte de NM (p. ej., enfermedad renal diabética, nefritis lúpica, nefropatía por IgA)
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of treatment-emergent adverse events (TEAE)
    Incidencia e intensidad de los acontecimientos adversos surgidos durante el tratamiento (AAST)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    E.5.2Secondary end point(s)
    KEY SECONDARY ENDPOINT: Best Immunological Response: rate of sICR, ICR and IPR based on re-duction of serum anti-PLA2R antibody titer
    SECONDARY ENDPOINTS:
    1. Number and antibody titers of subjects tested positive for anti-MOR202 antibodies
    2. MOR202 serum concentrations after multiple i.v. administrations
    3. Incidence and severity of AEs in the follow-up phase
    CRITERIO DE VALORACIÓN SECUNDARIO CLAVE:
    Mejor respuesta inmunológica: tasa de RCIs, RCI y RPI en base a la reducción del título de anticuerpos anti-PLA2R en suero
    CRITERIOS DE VALORACIÓN SECUNDARIOS:
    1. Número y títulos de anticuerpos de los sujetos que dieron positivo para anticuerpos anti-MOR202
    2. Concentraciones séricas de MOR202 después de múltiples administraciones por vía i.v.
    3. Incidencia e intensidad de las reacciones adversas al fármaco (RAF) en la fase de seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    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
    Inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib/IIa
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    United States
    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
    LVLS
    Ultima visita del último sujeto20
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 20
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 30
    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)
    Further treatment according to the current and local medical practice, on discretion of the treating physician.
    Tratamiento adicional según la práctica médica actual y local, a discreción del médico tratante.
    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 Decision2019-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-24
    P. End of Trial
    P.End of Trial StatusRestarted
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