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    The EU Clinical Trials Register currently displays   39233   clinical trials with a EudraCT protocol, of which   6427   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-004366-10
    Sponsor's Protocol Code Number:0642
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-02-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-004366-10
    A.3Full title of the trial
    A Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy
    A.4.1Sponsor's protocol code number0642
    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 SponsorUniversity of Leicester
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leicester
    B.5.2Functional name of contact pointDr. Chee Kay Cheung
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Infection, Immunity and Inflammation, University Rd
    B.5.3.2Town/ cityLeicester
    B.5.3.3Post codeLE1 7RH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01162584195
    B.5.5Fax number01162584764
    B.5.6E-mailcheekay.cheung@uhl-tr.nhs.uk
    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® (belimumab)
    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® (belimumab)
    D.3.2Product code GSK1550188
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 codeUOL 0642
    D.3.9.3Other descriptive nameGSK1550188; Benlysta
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Yes
    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 injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immunoglobulin A (IgA) nephropathy
    E.1.1.1Medical condition in easily understood language
    IgA nephropathy (IgAN) is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) lodges in the filters of the kidneys, causing progressive kidney damage.
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether treatment with belimumab for 12 months can modulate proteinuria in patients with IgA nephropathy.
    E.2.2Secondary objectives of the trial
    • To evaluate whether treatment with belimumab for 12 months can modulate autoantigen and antibody production in IgA nephropathy.
    • To evaluate the safety and tolerability of 12 months treatment with belimumab in IgA nephropathy.
    • To evaluate the effect of belimumab compared to placebo on renal function in IgA nephropathy.
    • To evaluate the effect of 12 months treatment with belimumab on pharmacodynamic (PD) markers and other markers of autoimmunity and their relationship with clinical measures in IgA nephropathy.
    • To evaluate the effect of 12 months treatment with belimumab on quality of life in IgA nephropathy.
    • To evaluate the sustainability of any change in proteinuria, PD markers and quality of life in the 12 months following treatment with belimumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects with IgAN, aged between 18-75 years
    • Biopsy proven IgAN, with an IgAN Oxford Classification Score of M1 and/or E1 and T0/1
    • Clinically active disease, defined by proteinuria ≥ 0.5 g/24h (PCR ≥ 50 mg/mmol) on two separate occasions despite at least 3 months of maximized supportive therapy
    • Female subjects not of child bearing potential, or of child bearing potential agreeing to use one of the contraceptive methods listed in the protocol

    Other protocol defined inclusion criteria may apply.
    E.4Principal exclusion criteria
    • Secondary cause of IgAN, or renal impairment due to a condition that is not IgAN
    • Severely reduced or deteriorating kidney function, defined by an eGFR < 30 ml/min at screening, or >15% decrease in eGFR in 3 months before screening
    • Nephrotic syndrome
    • Uncontrolled hypertension (>150/90 mmHg)
    • Concomitant or recent immunosuppression
    • Participation in another clinical trial of an investigational medicinal product (a minimum period of 1 year will be allowed between study completion of a biological investigational agent and commencement of this study, or 2 months for a non-biologic investigational agent)
    • Use of traditional herbal medicines
    • Prior use of biologic and/or cytotoxic therapies, and/or live vaccines within specified time periods
    • Major organ transplant
    • Malignant neoplasm within last 5 years
    • Acute, chronic or recurrent infection
    • Liver disease or abnormal liver function tests
    • Significant unstable or uncontrolled co-morbid conditions
    • Positive serology (HIV, Hepatitis B or C)
    • History of primary immunodeficiency
    • Significant IgG deficiency
    • IgA deficiency
    • Laboratory test abnormalities
    • Drug sensitivity/anaphylaxis
    • Drug or alcohol abuse or dependence
    • Blood donation during the study period
    • Serious suicide risk or suicidal ideation

    Other protocol defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    • Percent change from baseline in proteinuria at Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    • Change from baseline in proteinuria levels
    • Change from baseline in autoantigen and antibody production
    • Safety and tolerability, as assessed by evaluation of adverse events (AE), clinical laboratory assessments (clinical chemistry, haematology, urinalysis), and vital signs
    • Change from baseline in renal function (serum creatinine, eGFR)
    • Change from baseline in pharmacodynamic/biomarker endpoints, which may include B and T cell populations, cytokines/chemokines, autoantibody profile, as data permit
    • Change from baseline in SF-36 v2 Quality of Life (QoL) questionnaire score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 52 and 104 depending on endpoint
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 21
    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)
    There is currently no provision for continued use of belimumab following completion of the trial. Participants will continue to be monitored for 12 months following the last dose, and will then return to their previous clinical care, according to best medical practice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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