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    Summary
    EudraCT Number:2019-000780-24
    Sponsor's Protocol Code Number:MOR202C103
    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:2020-01-22
    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 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
    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
    A.4.1Sponsor's protocol code numberMOR202C103
    A.5.4Other Identifiers
    Name:IND Number Number: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+49898992726640
    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
    E.1.1.1Medical condition in easily understood language
    Membranous Nephropathy (a condition of the kidneys).
    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)
    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
    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.
    13. Female of non-childbearing potential fulfilling one of the criteria:
    a. post-menopausal: after 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms)
    b. surgically sterile: tubal ligation at least 6 weeks before taking trial treatment, hysterectomy, or bilateral oophorectomy
    c. genetically sterile: e. g. Turner syndrome, uterine agenesis.
    14. Sexually active females of reproductive potential should use one of the following contraception options until 3 months after the last dose of MOR202:
    a. One method of contraception that has a typical use failure rate of <1% (i.e., less than 1 pregnancy expected per 100 women), which would include
    sterilization surgery for women, sterilization implant for women, sterilization surgery for men, Copper IUD, IUD with progestin, or implantable rod
    b. A hormonal method of contraception (i.e., shot/injection, oral contraceptive, contraceptive patch, vaginal contraceptive ring, having typical use failure rate ≤ 9%) plus a barrier method (i.e., diaphragm with spermicide, sponge with spermicide, cervical cap with spermicide, male condom, female condom, spermicide alone).

    Note: France will only enroll patients in Cohort 2.
    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)
    8. Diabetes mellitus type 1
    9. Diabetes mellitus type 2: Subjects with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to screening shows membranous nephropathy without histological signs of diabetic nephropathy and their disease is controlled, such as:
    o Hba1c <8.0 % or 64 mmol/mol,
    o No diabetic retinopathy known
    o No peripheral neuropathy known
    10. Previous treatment with an anti-CD38 antibody
    Note: Cohort 1 specific criteria are not applicable in France
    11. Cohort 1 newly diagnosed subjects only: previous treatment for MN with alkylating agents, RTX, cyclosporine, tacrolimus, MMF, all with or without corticosteroids
    12. Cohort 1 relapse subjects and Cohort 2: Treatment within 3 months prior to screening with alkylating agents, RTX, CSA, tacrolimus, MMF, all with or without corticoster-oids
    13. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator
    14. Clinically relevant findings on a 12 lead ECG as determined by the investigator at screening
    15. History of significant cerebrovascular disease or sensory or motor neuropathy of tox-icity ≥ grade 3
    16. Total bilirubin, aspartate aminotransferase and alanine aminotransferase >1.5 x ULN, alkaline phosphatase >2.0 x ULN
    17. Treatment within five terminal half-lives (if known) or within the last 30 days prior to baseline (whatever is longer) with investigational drugs.
    18. Known or suspected hypersensitivity to MOR202 and its excipients (L-histidine, su-crose, polysorbate 20)
    19. Serologic or virologic markers positive for active or latent hepatitis B, C, or HIV at screening (central lab, HBsAg positive subjects are not eligible; HBcAb positive sub-jects are only eligible, if HBsAb is positive as well)
    20. For any other preexisting symptoms and impairments of health classified or any re-sidual toxicity from prior therapy ≥ grade 3 (NCI-CTCAE, see 3.2): these subjects may be included upon confirmation by the medical department of the sponsor
    21. Pregnancy or breast feeding
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of treatment-emergent adverse events (TEAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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
    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.8.5The 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
    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 state
    F.4.2 For a multinational trial
    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.
    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 Decision2019-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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