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    Summary
    EudraCT Number:2020-005054-19
    Sponsor's Protocol Code Number:MOR202C206
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-18
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-005054-19
    A.3Full title of the trial
    A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy
    A.4.1Sponsor's protocol code numberMOR202C206
    A.5.4Other Identifiers
    Name:INDNumber: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 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 Operations
    B.5.3 Address:
    B.5.3.1Street AddressSmartLabs, 2 Tower Place, HI-Bio - 16th Floor
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1408214 2419
    B.5.5Fax number+1888 235 6126
    B.5.6E-mailkaren@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 nameFelzartamab
    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 INNFelzartamab
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for 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
    IgA Nephropathy (IgAN)
    E.1.1.1Medical condition in easily understood language
    Autoimmune kidney diseases IgA nephropathy
    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 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
    To assess the efficacy of Felzartamab compared to placebo in patients with IgAN based on the change in urine protein to creatinine ratio (UPCR) at 9 months.
    E.2.2Secondary objectives of the trial
    To assess the relationship between exposure, safety, and efficacy in each of the three dose groups vs. placebo to support a decision for a dose in further trials
    To assess the efficacy of Felzartamab compared to placebo in patients with IgAN based on the following:
    - Change in UPCR at 3, 6, 12, 18 and 24 months
    - Complete response (CR) at 3, 6, 9, 12, 18 and 24 months
    - Proportion of patients with response at 3, 6, 9, 12, 18 and 24 months
    - Albumin-creatinine ratio (ACR) at 6, 9, 12, 18 and 24 months
    - Duration of response
    - Time to response
    To assess the renal function of Felzartamab compared to placebo in patients with IgAN.
    To assess the safety of Felzartamab in patients with IgAN.
    To assess the pharmacokinetic (PK) profile of Felzartamab in patients with IgAN.
    To investigate the potential immunogenicity of Felzartamab in patients with IgAN
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least
    of legal age in the given country
    2. Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF
    3. Proteinuria at screening visit ≥ 1.0 g/d
    4. Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control (recommended BP is < 125 mm Hg systolic and < 75 mm Hg diastolic).
    In case a patient is intolerant to even a very low dose of either ACEi or ARB therapy, approval for participation in the trial has to be obtained from the Medical Monitor prior to randomization.
    5. A female of childbearing potential (FCBP) is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance 5 during the treatment period and for at least 3 months after the last dose of Felzartamab.
    E.4Principal exclusion criteria
    1. Secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits (e.g. Lupus nephritis, Schönlein-Henoch purpura, ankylosing spondylitis, dermatitis herpetiformis, chronic liver disease, inflammatory bowel disease, celiac disease).
    2. Severe renal impairment as defined by estimated GFR < 30 mL/min (using chronic kidney
    disease-epidemiology collaboration [CKD-EPI] formula) or the need for dialysis or renal transplant.
    3. Rapidly progressive variant of IgAN, defined as eGFR loss by more than 30% per 3 months and not explained by changes in renin angiotensin system (RAS) blockade.
    4. Minimal change variant of IgAN.
    5. Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
    6. Systemic immunosuppression (e.g. mycophenolate mofetil [MMF], cyclophosphamide, biologics like rituximab [RTX]), in particular corticosteroid therapy exceeding 20 mg/day prednisone-equivalent for more than 7 consecutive days within 180 days prior to signing ICF.
    7. Any previous treatment with an anti-CD38 antibody.
    8. Body mass index (BMI) > 35 kg/m^2.
    9. Hemoglobin < 90 g/L.
    10. Thrombocytopenia: Platelets < 100.0 x 10^9/L.
    11. Neutropenia: Neutrophils < 1.5 x 10^9/L.
    12. Leukopenia: Leukocytes < 3.0 x 10^9/L.
    13. Diabetes mellitus type 1.
    14. Diabetes mellitus type 2: Patients with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to signing ICF shows IgAN without evidence of diabetic nephropathy and their disease is controlled, such as:
    a. Glycated hemoglobin (HbA1c) < 8.0% or < 64 mmoL/mol.
    b. No diabetic retinopathy known.
    c. No peripheral neuropathy known.
    15. Significant uncontrolled cardiovascular disease (including arterial or venous thrombotic or embolic events) or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator.
    16. Clinically significant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening.
    17. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity ≥ grade 3.
    18. Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN.
    19. Known or suspected hypersensitivity to Felzartamab and its excipients (L-histidine, sucrose, polysorbate 20).
    20. Serologic markers positive for HIV or history of HIV, hepatitis C (patients with positive anti-hepatitis 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). For patients with positive hepatitis B core antibody [anti-HBc], hepatitis B virus (HBV) DNA test by PCR must be non-detectable to enroll).
    21. 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 other non-melanomatous skin cancer.
    22. Treatment within 5 terminal half-lives (if known) or within the last 30 days prior to Visit 2, whatever is longer) with investigational drugs.
    23. Any active infection (viral, fungal, bacterial) requiring systemic therapy.
    E.5 End points
    E.5.1Primary end point(s)
    Relative change in UPCR in 24h urine compared to the reference proteinuria value in the Felzartamab dose groups vs. placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months
    E.5.2Secondary end point(s)
    Integrative analysis of several endpoints.
    Relative change in UPCR in 24h urine compared to the reference proteinuria value in each Felzartamab dose group vs. placebo.
    Complete response in each Felzartamab dose group vs. placebo.
    Proportion of patients with response in each Felzartamab dose group vs. placebo.
    Albumin-creatinine ratio from 24 h urine in each Felzartamab dose group vs. placebo.
    Duration of response in each Felzartamab dose group vs. placebo.
    Time to response in each Felzartamab dose group vs. placebo.
    Renal function (determined by estimated glomerular filtration rate [eGFR] over time) in each Felzartamab dose group vs. placebo.
    Frequency, incidence, seriousness, relatedness, and severity of treatment-emergent adverse events (TEAEs) across all treatment groups.
    Serum concentrations of Felzartamab over time in each Felzartamab dose group.
    Formation of anti-drug antibodies (ADAs) over time in all groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis will be performed after all randomized patients in Part I of the study have completed their 9 month-visit or discontinued the trial earlier. The final analysis of all endpoints will be performed after all randomized patients (both Part I and Part II) have completed their last visit, or discontinued the trial earlier.
    The secondary endpoints will be assessed at 3, 6, 9, 12, 18, 24 months as defined per each in 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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Australia
    Canada
    Japan
    Korea, Republic of
    Malaysia
    Philippines
    Taiwan
    United States
    Georgia
    Ukraine
    Serbia
    Belgium
    Bulgaria
    Czechia
    Germany
    Spain
    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 months1
    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 months1
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 48
    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)
    Best standard of care at investigator's discretion
    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 Decision2021-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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