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    Summary
    EudraCT Number:2011-000242-38
    Sponsor's Protocol Code Number:BEL114674
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-11-13
    Trial results View 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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-000242-38
    A.3Full title of the trial
    BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 2 year study to investigate belimumab in membranous nephropathy

    A.3.2Name or abbreviated title of the trial where available
    GSK1550188 in membranous nephropathy
    A.4.1Sponsor's protocol code numberBEL114674
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 4466
    B.5.5Fax number+44208990 1234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 BENLYSTA®
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    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 nameBENLYSTA®
    D.3.2Product code GSK1550188 (Belimumab)
    D.3.4Pharmaceutical form Powder 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 INNBELIMUMAB
    D.3.9.1CAS number 356547-88-1
    D.3.9.2Current sponsor codeGSK1550881
    D.3.9.4EV Substance CodeSUB25607
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    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
    Idiopathic Membranous Nephropathy (IMN)
    E.1.1.1Medical condition in easily understood language
    Idiopathic Membranous Nephropathy (IMN)
    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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10038359
    E.1.2Term Renal and urinary disorders
    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 evaluate the efficacy of 10mg/kg belimumab for the treatment of IMN as measured by remission of proteinuria at 2 years.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of belimumab 10mg/kg over a 2 year period in IMN.
    • To evaluate efficacy through other measures of disease activity over a 2 year period.
    • To evaluate the pharmacokinetics of belimumab in IMN over a 2 year period .
    • To evaluate the effect of belimumab on pharmacodynamic markers and other markers of autoimmunity and their relationship with clinical efficacy in IMN over a 2 year period
    • To evaluate the effect of belimumb on quality of life in IMN over a 2 year period
    • To evaluate the benefit of earlier treatment with belimumab compared to delayed treatment with current immunosuppressive treatment regimens during 2 years in the treatment period of the main clinical study and whether there is a positive effect following 2 years treatment in a 5 year off investigational drug follow-up period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. Age & Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent.
    2. Histological diagnosis: Have clinical diagnosis of IMN, as verified by biopsy (either by light microscope with immuno-fluorescence, or by electron microscope) in the last 3 years (biopsy results [and slides, where possible], should be available for independent evaluation). For patients with relapsed disease (see inclusion 3), a biopsy should be available within the preceding 7 years.
    3. Proteinuria: Have clinically active disease (nephrotic range proteinuria) for at least 3 months prior to screening and no improvement (<30% reduction), despite supportive therapy (which must include maximal tolerated doses of ACE inhibitor or ARB unless contraindicated, and may include statins, diuretics, dietary salt restriction). During screening proteinuria must be >400mg/mmol by uPCR (or >4.0g per 24 h) as measured from a 24 h urine collection and/or spot urine sample (early morning where possible) on 2 occasions at least 7 days apart.
    Proteinuria in patients with relapsed disease: Patients who previously achieved proteinuria <2g per 24h for at least 6 months and have subsequently relapsed with proteinuria levels as documented above, may be eligible providing recurrence has been within the previous 3 years and patient is known to be anti-PLA2R positive.
    4. Female Subjects: A female subject is eligible to participate if she is not pregnant or nursing and at least one of the following conditions apply:
    a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/mL (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
    b. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose.
    French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    E.4Principal exclusion criteria
    1. Non-Idiopathic MN or other condition affecting the kidney: If the diagnosis of MN is secondary to other conditions, or the subject has renal impairment from a condition that is not MN.
    Causes of secondary MN include (but are not limited to):
    Immune diseases: Systemic lupus erythematosus, diabetes mellitus; rheumatoid arthritis, Hashimoto’s disease, Grave’s disease, mixed connective tissue disease, Sjogren’s syndrome, primary biliary cirrhosis, bullous pemphigoid, small bowel enteropathy syndrome, dermatitis herpetiformis, ankylosing spondylitis, graft-versushost- disease, Guillain-Barre syndrome.
    Infectious or parasitic diseases: Hepatitis B; Hepatitis C, syphilis, filariasis, hydatid disease, schistosomiasis, malaria, leprosy.
    Drugs and toxins: Gold, penicillamine, non-steroidal anti-inflammatory agents, mercury, captopril, formaldehyde, hydrocarbons, bucillamine. Miscellaneous: Tumors (excluded with reasonable diligence), renal transplantation, sarcoidosis, sickle cell disease, Kimura disease, angiofollicular lymph node hyperplasia.
    2. Anti-PLA2R autoantibody: Patients known to be negative for anti-PLA2R autoantibody.
    3. Severely reduced or deteriorating kidney function: An eGFR at screening < 40 mL/min/1.73m2 (as determined by 4 variable version MDRD equation) or kidney function not stable (as defined by > 15% decrease in eGFR in 3 months before screening unless due to medication change).
    4. Blood Pressure: Uncontrolled hypertension defined as blood pressure (BP) > 150/90 mm Hg (treatment target ≤ 140/80) as assessed by either:
    a. Blood pressures measured 3 times on each of at least 2 clinic visits during screening, after the patient has sat quietly for at least 5 minutes, with >50% of measurements being >150/90 or
    b. Average daytime blood pressure on a 24 hour ambulatory blood pressure monitor.
    5. Prior Therapy: Have received treatment with the following therapies at the times specified prior to Day 0 (Please see section 5.2.2; pages 45-49 of the Protocol for further information).
    6. Transplantation: Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
    7. Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
    8. Acute or chronic infection: Have required management of acute or chronic infections, (Please see section 5.2.2; pages 45-49 of the Protocol for further information).
    9. Liver disease: Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    10. Other diseases/conditions: Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to IMN (i.e., cardiovascular, pulmonary, haematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
    (Please see section 5.2.2; pages 45-49 of the Protocol for further information).
    11. Positive serology: Have a historically positive HIV test or test positive at screening for HIV. Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs
    (Please see section 5.2.2; pages 45-49 of the Protocol for further information).
    12. Liver function tests: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    13. Immunodeficiency: Have an IgA deficiency (IgA level < 10 mg/dL) or have IgG level <250 mg/dL and have previously received any non-glucocorticoid immunosuppression during the previous 6 months.
    14. Laboratory test abnormalities: Have clinically significant abnormalities in screening laboratory assessments (not related to the disease), as judged by investigator.
    15. Drug sensitivity / Anaphylaxis: History of sensitivity or intolerance to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
    (Please see section 5.2.2; pages 45-49 of Protocol for further information).
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of remission (complete or partial) at Week 104
    (complete remission [CR] is defined as uPCR < 30mg/mmol (proteinuria <0.3g protein/24h) with no worsening of renal function (less than 15% reduction in eGFR from baseline); partial remission [PR] is defined as uPCR < 350mg/mmol [proteinuria <3.5g /24hrs] but ≥ 30mg/mmol [proteinuria ≥0.3g /24hrs] AND a decrease of > 50% from baseline (Day 0) based on uPCR, together with no worsening of renal function [less than 15% reduction in eGFR from baseline]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 104
    E.5.2Secondary end point(s)
    • Incidence of progression of IMN or failure to respond as defined by at least one of the following:
    1. Persistent symptomatic nephrotic syndrome potentially necessitating rescue therapy due to:
    • Persistent nephrotic range proteinuria with <30% improvement after at least 6 months observation, or deterioration in proteinuria (>30% increase from baseline) at any time OR
    • Symptoms or other clinically significant evidence of severe nephrotic syndrome- i.e. morbid oedema (defined as oedema that is distressing to a patient because of prolonged duration and inability to achieve adequate control with loop diuretics) or subclinical evidence of thromboembolism, severe hypoalbuminaemia (reduction by 5g/L from baseline and <20g/L) OR
    • Deterioration in renal function - decrease in eGFR from baseline by >20% OR
    • Persistent severe hypogammaglobulinaemia, <250mg/dL- continuing for >6 months.
    2. ESRD (eGFR <15mL/min/1.73m2, dialysis or transplantation)
    3. Clinical thromboembolic events
    4. Death

    Other Secondary Endpoints
    • Time to complete remission
    • Time to partial remission
    • Change from baseline in proteinuria levels at Week 104
    • Change from baseline in serum albumin levels at Week 104
    • Change from baseline in eGFR at Week 104
    • Time to first thromboembolic event
    • Change from baseline in KDQOL-36 score at Week 104
    • Incidence of partial remission at Week 104
    • Incidence of complete remission at Week 104
    • Duration of remission (complete or partial)
    • Risk-benefit calculation based on key efficacy and safety endpoints using a clinical utility index
    Key Safety Endpoints
    • Incidence of serious adverse events (SAEs)
    • Incidence of AEs of special interest:
    • Serious infusion reactions/hypersensitivity/anaphylaxis
    • Fatal events
    • Serious malignancies
    • Serious infections including herpes zoster
    • Cardiovascular SAEs (fatal and non-fatal events) including arrhythmia;
    Congestive Heart Failure, Cerebrovascular Accident, Deep Vein
    thrombosis, Myocardial Infarction/unstable angina; peripheral arterial thromboembolism; revascularization
    • SAEs suggestive of suicidal or self-harming behavior for studies that are not prospectively assessing for suicidality using the C-SSRS and Possible Suicidality Related Questionnaire (PSRQ)

    Other (Endpoints)
    There will be a formal analysis of other endpoints at Weeks 28, 52, 76 and 104/4 week post last dose, unless otherwise stated or already specified in primary and secondary endpoints. Data from other visits will be provided as supporting/descriptive analyses. For proteinuria, absolute values (by uPCR) will be determined at all time points to model temporal effects.
    • Change from baseline in proteinuria levels
    • Incidence of partial remission
    • Incidence of complete remission
    • Incidence of complete or partial remission at any time during 104 weeks treatment
    • Incidence of relapse over 104 weeks
    (relapse is defined as: uPCR>350mg/mmol (proteinuria > 3.5g/24 hrs) AND increase of 50% from lowest remission level, in those patients who had previously achieved any type of remission)
    • Time to relapse (starting from time of first achievement of any type of remission)
    • Change from baseline in eGFR
    • Incidence of >20% decrease in eGFR at any time
    • Change from baseline in serum creatinine levels
    • Incidence of >50% increase in serum creatinine any time
    • Change from baseline in serum albumin levels
    • Change from baseline in cholesterol levels
    • Incidence of oedema by severity
    • Change from baseline in KDQOL-36 questionnaire score by visit
    • Change from baseline in Membranous Nephropathy Quality of Life (MN QOL) questionnaire score by visit
    • Change from baseline in Workplace Productivity and Activity Impairment (WPAI) questionnaire score by visit
    • Change from baseline in 6 minute walk test (6MWT)
    • Unscheduled healthcare contacts/resource utilisation
    • Requirement for rescue therapy
    • Change from baseline in anti-PLA2R antibody levels
    • Incidence of anti-PLA2R antibody remission.
    • Full response: Antibody undetectable
    • Partial response: Reduction in titres by 50%
    • Time to anti-PLA2R antibody remission
    • Serum belimumab C(0-30min), Cmin, AUC(0-tau), and urine Ae(0-24)
    • Pharmacodynamics/biomarkers: May include change in B-cells and other lymphocyte subsets, urine membrane attack complex (MAC), neutrophil gelatinase-associated lipocalin (NGAL), selective proteinuria, BLyS levels, autoantibody profile, change in transcriptomic profile, by visit, as data permit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 104
    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 Yes
    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 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 Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Czech Republic
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 94
    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)
    Subjects will not receive any additional treatment from GSK after completion of the 2 year treatment period of the main clinical study because other treatment options are available and for subjects in remission, the value of belimumab maintenance therapy is unclear. Equally for subjects who have not achieved remission with belimumab by two years, the value of extending therapy beyond two years is unclear.
    (Please see section 10.4; page 75 of the Protocol for further information).
    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 Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-10-23
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