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    Summary
    EudraCT Number:2019-004034-42
    Sponsor's Protocol Code Number:CA41705
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-04-10
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-004034-42
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH ISN/RPS 2003 CLASS III OR IV LUPUS NEPHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis
    A.4.1Sponsor's protocol code numberCA41705
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Yes
    D.2.1.1.1Trade name Gazyvaro
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameobinutuzumab
    D.3.2Product code RO5072759
    D.3.4Pharmaceutical form 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 INNOBINUTUZUMAB
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRO5072759
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Myfenax
    D.2.1.1.2Name of the Marketing Authorisation holderTeva B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namemycophenolate mofetil
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmycofenolate mophetyl
    D.3.9.3Other descriptive nameMYCOPHENOLATE MOFETIL
    D.3.9.4EV Substance CodeSUB03360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for concentrate for solution 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
    lupus nephritis
    E.1.1.1Medical condition in easily understood language
    LN is inflammation of the kidney that is caused by systemic lupus erythematosus (SLE) which is an autoimmune disease in which the
    body's immune system mistakenly attacks healthy tissue.
    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 PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of obinutuzumab compared with placebo based on proportion of patients who achieve a complete renal response (CRR) at Week (WK) 76
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of obinutuzumab compared with placebo
    based on proportion of patients who achieve proteinuric response at WK
    76, overall renal response (ORR) at WK 50, proportion of patients who
    experience death or renal-related events and mean change in eGFR from
    baseline to WK 76, proportion of patients who achieve CRR with
    successful prednisone taper at WK 76, change in anti-double stranded
    DNA antibody (anti-dsDNA) titer and C3 from baseline to WK 50, change
    in SLE Disease Activity Index 2000 (SLEDAI-2K) from baseline to WK 76,
    time to onset of CRR and change in Functional Assessment of Chronic
    Illness Therapy-Fatigue (FACIT-F) from baseline to WK 76, proportion of
    patients who achieve CRR with serum creatinine criteria at WK 76.
    • To evaluate safety of obinutuzumab compared with placebo
    • To characterize obinutuzumab pharmacokinetic profile
    • To evaluate immune response to obinutuzumab
    • To characterize obinutuzumab-induced changes in circulating B-cells
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-75 years
    - Ability to comply with the study protocol, in the investigator's
    judgment
    - Active or active/chronic International Society of Nephrology / Renal
    Pathology Society (ISN/RPS) 2003 Class III or IV proliferative LN by
    renal biopsy performed in the 6 months prior to screening or during
    screening
    XML File Identifier: OiHS8XjxxANYWOoJmetVc/TGaSE=
    Page 15/26
    - SLE according to the 2019 European League Against Rheumatism/
    American College of Rheumatology (EULAR/ACR) Classification Criteria,
    which are met by the presence of Class III or IV LN (above) and: Current
    or past positive antinuclear antibody (ANA), as evidenced by ANA at a
    titer of >= 1:80 on HEp-2 cells or an equivalent positive ANA test at least
    once
    - Urinary protein-to-creatinine ratio >= 1 g/g on a 24-hour collection
    at screening
    - Receipt of at least one dose of pulse methylprednisolone IV (>= 250
    mg) or equivalent for treatment of the current episode of active LN
    during the 6 months prior to screening or during screening; or to be
    given on Day 1 prior to the first infusion. A maximum of 3 g
    methylprednisolone IV or equivalent during the 4 weeks prior to
    screening or during screening is allowed.
    - For women of childbearing potential: agreement to remain abstinent
    or use highly effective contraception, women must remain abstinent or
    use two reliable methods of contraception, including at least one method
    with a failure rate of < 1% per year, during study treatment and for 18
    months after the final dose of obinutuzumab and 6 weeks after the final
    dose of mycophenolate mofetil (MMF)
    - For men: agreement to remain abstinent or use contraceptive
    methods, and agreement to refrain from donating sperm, with a female
    partner of childbearing potential, men who are not surgically sterile
    must remain abstinent or use a condom plus an additional contraceptive
    method used by the female partner that together result in a failure rate
    of < 1% per year during the treatment period and for 90 days after the
    final dose of MMF, men must remain abstinent or use a condom during
    the treatment period
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding, or intending to become pregnant during
    the study or within 18 months after the final dose of obinutuzumab or
    placebo or within 6 weeks after the final dose of MMF
    - Severe renal impairment, as defined by eGFR < 30 mL/min/1.73 m2
    or the need for dialysis or renal transplantation
    - Sclerosis in > 50% of glomeruli on renal biopsy
    - Presence of rapidly progressive glomerulonephritis
    - Receipt of an excluded therapy
    - Severe, active central nervous system SLE, including retinitis, poorlycontrolled
    seizure disorder, acute confusional state, myelitis, stroke,
    cerebellar ataxia, or dementia
    - High risk for clinically-significant bleeding or any condition requiring
    plasmapheresis, intravenous immunoglobulin, or acute blood product
    transfusions
    - Significant or uncontrolled medical disease which, in the
    investigators opinion, would preclude patient participation
    - HIV and Tuberculosis infection; latent TB after completion of
    appropriate treatment is not exclusionary.
    - Active infection of any kind, excluding fungal infection of the nail
    beds
    - Any major episode of infection that required hospitalization or
    treatment with IV or oral antibiotics or anti-infectives during the 8
    weeks prior to screening or during screening.
    - History of serious recurrent or chronic infection
    - History of progressive multifocal leukoencephalopathy
    - History of cancer, including solid tumors, hematological
    malignancies, and carcinoma in situ, within the past 5 years
    - Major surgery requiring hospitalization during the 4 weeks prior to
    screening or during screening
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    - Current alcohol or drug abuse or history of alcohol or drug abuse
    within 12 months prior to screening or during screening
    - Intolerance or contraindication to study therapies
    - Laboratory parameters
    • AST or ALT > 2.5 × upper limit of normal (ULN)
    • Amylase or lipase > 2 × ULN
    • Neutrophils < 1.5 × 103/μL
    • Positive hepatitis B surface antigen (HBsAg)
    • Positive hepatitis C serology
    • Hemoglobin < 7 g/dL, unless caused by autoimmune hemolytic
    anemia resulting from SLE
    • Platelet count < 25,000/μL
    • Positive serum human chorionic gonadotropin measured at screening
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who achieve a CRR at Week 76
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 76
    E.5.2Secondary end point(s)
    1. Proportion of patients who achieve a proteinuric response at Week 76
    2. Proportion of patients who achieve CRR with successful prednisone
    taper at Week 76
    3. Proportion of patients who achieve an ORR, evaluated at Week 50
    4. Proportion of patients who experience death or renal-related events
    through Week 76
    5. Mean change in eGFR from baseline to Week 76
    6. Change in anti-dsDNA titer from baseline to Week 50
    7. Change in C3 from baseline to Week 50
    8. Change in SLEDAI-2K from baseline to Week 76
    9. Time to onset of CRR over the course of 76 weeks
    10. Change in FACIT-F scale from baseline to Week 76
    11. Proportion of patients who achieve CRR with serum creatinine
    criteria at Week 76
    12. Incidence and severity of adverse events, with severity determined
    according to National Cancer Institute Common Terminology Criteria for
    Adverse Events (NCI CTCAE) v5.0
    13. To characterize adverse events of special interest, including among
    others, IRRs, neutropenia, infections and thrombocytopenia.
    14. Change from baseline in targeted vital signs
    15. Change from baseline in targeted clinical laboratory test results
    16. Maximum observed concentration (Cmax) of obinutuzumab
    17. Minimum observed concentration (Cmix) of obinutuzumab
    18. Area under concentration- time curve (AUC) of obinutuzumab
    19. Clearance (CL) of obinutuzumab
    20. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence
    of ADAs post-treatment during the study
    21. Total peripheral B-cell count at specified timepoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. At Week 76
    3. At Week 50
    4-5. At Week 76
    6-7. Baseline (Day 1) to Week 50
    8-11. Baseline to Week 76
    12-15. Up to 8 years
    16-19. Baseline, WK 2, 4, 12, 24, 26, 36, 50, 52, 64, 76, 80, 106,
    132,158, 184, every 6 months thereafter, unplanned visit (UV) and at
    study discontinuation (SD); open label extension(OLE): WK 0, 2, 4, 12,
    24, 26, 36, 52, 76, every 6 months thereafter, UV, SD
    20. Baseline, Week 2, 4, 12, 24, 36, 50, 76, 80, 106, 132,158, 184, every
    6 months thereafter, unplanned visit (UV) and at study discontinuation
    (SD); open label extension(OLE): WK 0, 2, 12, 24, 36, 52, 76, every 6
    months thereafter, UV, SD
    21. Baseline, WK 4, 24, 50, 76, 106, 132, 158, 184 every 6 months
    thereafter, open label extension(OLE): WK 0, 4, 24, 52, 76, every 6
    months thereafter
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial3
    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 concerned15
    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 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
    Argentina
    Brazil
    Canada
    Colombia
    Israel
    Mexico
    Peru
    South Africa
    United States
    Russian Federation
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    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
    The end of this study is defined as the date when the last patient, last
    visit (LPLV), occurs or the date at which SFU is received from the last
    patient up to a maximum of 18 months from the last obinutuzumab
    infusion (blinded and open-label). The end of the study is expected to
    occur approximately 8.5 years after the last patient is enrolled. In
    addition, the Sponsor may decide to terminate the study at any time.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years11
    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: 236
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If patients cannot read the consent or they have relatives with the legal ability to make medical decisions for them, they would be able to be included in the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 250
    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)
    The Sponsor will offer continued access to Roche IMP (obinutuzumab and MMF) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in the protocol, section 4.3.5.
    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 Decision2020-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-28
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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