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    Summary
    EudraCT Number:2020-002985-15
    Sponsor's Protocol Code Number:MOR202C205
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-11
    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 ConcernedGreece - EOF
    A.2EudraCT number2020-002985-15
    A.3Full title of the trial
    A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)
    A.3.2Name or abbreviated title of the trial where available
    NewPLACE
    A.4.1Sponsor's protocol code numberMOR202C205
    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 SponsorHuman Immunology Biosciences, 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 supportHuman Immunology Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHuman Immunology Biosciences, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address2 Tower Place, HIBio - 16th Floor
    B.5.3.2Town/ citySouth San Francisco, CA,
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+14082142429
    B.5.5Fax number+18882356126
    B.5.6E-mailclinicaltrials@hibio.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.3.4Pharmaceutical 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 INNnot yet assigned
    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 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
    Anti-PLA2R antibody positive membranous nephropathy (aMN)
    E.1.1.1Medical condition in easily understood language
    Membranous nephropathy (MN)
    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 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 efficacy of 2 different dosing regimens of MOR202 in subjects with anti PLA2R antibody positive MN
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of 2 different dosing regimens of MOR202
    • To assess the safety of MOR202
    • To assess the PK profile of MOR202
    • To investigate the potential immunogenicity of MOR202
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]).
    2. Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g (as determined by a 24 h urine collection) or proteinuria ≥ 3.5 g/24 h (as determined by a 24 h urine collection)
    3. Anti-PLA2R antibody positive MN in need for IST according to the investigator’s judgment. The diagnosis of MN should be histologically documented with a diagnostic biopsy; for this purpose, a biopsy at screening or an archival biopsy acquired within 5 years prior to screening is acceptable.
    4. Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m².
    Alternatively, subjects with an eGFR >30 and < 50 ml/min/1.73 m² can be included provided an interstitial fibrosis and tubular atrophy (IFTA) score of < 25% in a kidney biopsy is histologically documented; for this purpose, a biopsy at screening or an archival biopsy acquired within 6 months prior to start of screening is needed.
    5. Not in spontaneous remission despite proper treatment with angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARBs) (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to ACEI and ARBs, the reason must be documented and approval for enrollment be obtained from the Medical Monitor.
    6. Systolic blood pressure (BP) ≤ 150 mmHg and diastolic BP ≤ 100 mmHg after 5 minutes of rest.
    7. Serum anti-PLA2R antibodies ≥ 50.0 RU/mL determined by Euroimmun ELISA.
    8. Female subjects: A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    a. Not a female of childbearing potential (FCBP) ; OR
    b. A FCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of MOR202.
    E.4Principal exclusion criteria
    1. Hemoglobin < 80 g/L (4.9 mmol/L).
    2. Thrombocytopenia: Platelets < 100.0 x 10^9/L.
    3. Neutropenia: Neutrophils < 1.5 x 10^9/L.
    4. Leukopenia: Leukocytes < 3.0 x 10^9/L.
    5. B-cells < 5 x 10^6/L
    6. Secondary cause of MN (e.g. malignancies, medications, systemic lupus erythematosus).
    7. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, immunoglobulin A (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 MN without evidence of diabetic nephropathy and diabetes is controlled, as shown by:
    a. Glycated hemoglobin (HbA1c) <8.0 % or 64 mmol/mol.
    b. No diabetic retinopathy known.
    c. No peripheral neuropathy known.
    10. Previous treatment with an anti-CD38 antibody.
    11. Prior to screening start, oral or parenteral treatment with:
    a. Mycophenolate mofetil (MMF) or high dose corticosteroids (> 20 mg prednisone/day) within 30 days prior to start of screening.
    b. Alkylating agents (e.g. cyclophosphamide) or calcineurin inhibitors (CNIs) (e.g. tacrolimus, cyclosporine A) within 90 days.
    c. Biologic drugs including rituximab (RTX) within 180 days.
    d. Any other oral/parenteral IST within 180 days.
    12. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator.
    13. Clinically relevant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening.
    14. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity ≥ grade 3.
    15. Total bilirubin, aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN.
    16. Known or suspected hypersensitivity to MOR202 and its excipients (L-histidine, sucrose, polysorbate 20).
    17. All patients will be screened for HIV, HBsAg, HBsAb, HBcAb, HC Ab and Hepatitis C RNA. If a patient tests positive for any of the following: HIV, HBsAg, HBcAb or HC Ab or Hepatitis C RNA, then the patient should be excluded from the study. If a patient tests positive only for HBsAb,
    HBV-DNA should be tested and if this test result is positive the patient should be excluded from the study. Patients who test positive only for HBsAb and negative for HBV-DNA are eligible.
    18. For any other pre-existing symptoms and impairments of health or any residual toxicity from prior therapy classified ≥ grade 3 (NCI-CTCAE)
    19. Any malignancy within 5 years prior to screening start, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non melanomatous skin cancer.
    20. Treatment within 5 terminal half-lives (if known) or within the last
    30 days prior to baseline (whatever is longer) with investigational drugs.
    21. Any active infection (viral, fungal, bacterial) requiring systemic therapy.
    22. Any other disease which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the trial.
    23. Not applicable to EU sites.
    24. Individuals housed in institutions due to official or judicial orders or who are in positions of dependency vis-à-vis the sponsor or investigator are not eligible for participation.
    25. History or current hemostasis or bleeding disorder.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change of anti-PLA2R antibody levels
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months compared to baseline
    E.5.2Secondary end point(s)
    • Immunological complete response (ICR) rate
    • Overall proteinuria response (OPR) rate
    • Frequency, incidence and severity of treatment-emergent adverse events (TEAEs).
    • Serum concentrations of MOR202 over time.
    • Formation of anti drug antibodies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ICR: 3 months, 6 months, 12 months and 24 months
    OPR: 6 months, 12 months and 24 months
    Other time points are according to the Schedule of Activities in the study protocol
    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 Yes
    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 No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different dosing regimen
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Georgia
    Germany
    Greece
    Korea, Republic of
    Russian Federation
    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
    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 months11
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days4
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 22
    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)
    None
    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 Decision2020-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-14
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