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    Summary
    EudraCT Number:2011-006215-56
    Sponsor's Protocol Code Number:BEL114424
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-006215-56
    A.3Full title of the trial
    BEL114424: A Phase 2 Pilot, Multicentered, Randomised, Double Blind, Placebo-Controlled Study to Evaluate the Potential for Efficacy and the Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in the Prevention of Allograft Rejection in Adult Subjects After Renal Transplantation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of belimumab in the prevention of kidney transplant rejection
    A.4.1Sponsor's protocol code numberBEL114424
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01536379
    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 and 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
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address1-3, Iron Bridge Road
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442089904466
    B.5.5Fax number+442089901234
    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® (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 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 codeGSK1550188
    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
    Allograft Rejection in Adult Subjects After Renal Transplantation.
    E.1.1.1Medical condition in easily understood language
    Transplant rejection
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10023439
    E.1.2Term Kidney transplant rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy: To estimate the change in naive B cells following belimumab 10 mg/kg (or placebo) in addition to standard of care immunosuppressants in renal transplant patients from the time of transplantation up to 24 weeks.

    Safety: To assess the safety and tolerability of belimumab 10 mg/kg (or placebo) in renal transplant patients in addition to standard of care immunosuppressants.
    E.2.2Secondary objectives of the trial
    To further assess the pharmacodynamic effect of belimumab in addition to standard of care immunosuppressants in renal transplant patients at 24 weeks

    To assess the phenotype and tolerogenic profile of the repopulating B cells after belimumab therapy at week 52.

    To further assess the potential for efficacy of belimumab in addition to standard of care immunosuppressants in reducing the incidence of renal allograft rejection using biomarker and clinical outcomes.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title:
    Pharmacogenetic Research

    Objective:
    The objective of the PGx research (if there is a potential unexpected or unexplained variation) is to investigate a possible genetic relationship response to Belimumab. If at any time it appears there is potential variability in response in this clinical study or in a series of clinical studies with Belimumab that may be attributable to genetic variations of subjects, the following objectives may be investigated – the relationship between genetic variants and study treatment with respect to:
    - Pharmacokinetics and/or pharmacodynamics of study treatment
    - Safety and/or tolerability
    - Efficacy
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. Eligible for kidney transplantation: Considered eligible for transplantation
    after undergoing multidisciplinary evaluation at the institution at which transplantation will be performed
    2. Donor characteristics: Receiving a deceased donor kidney or a living donor kidney allograft
    3. Age & Gender: Male or female between 18 and 75 years of age, inclusive, at the time of signing the informed consent
    4. Female Subjects: 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 the absence of confirmatory laboratory assessments [(a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/mL and estradiol < 40 pg/ml (<147 pmol/L)] in questionable cases, female subjects will be required to use one of the contraception methods described in Section 7.1,
    Contraception Requirements, until confirmatory results become available.
    b. Questionable post-menopausal status and agrees to use one of the contraception methods listed in Section 7.1, Contraception Requirements, from Day 0 until 16 weeks after the last dose of investigational product or until postmenopausal status is confirmed with a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradiol < 40 pg/ml (<147 pmol/L). Females with questionable post-menopausal status who are using hormone replacement therapy (HRT) will be required to use one of the contraception methods in Section 7.1,
    Contraception Requirements, until post-menopausal status is confirmed. 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.
    c. Child-bearing potential and agrees to use one of the contraception methods listed in Section 7.1, Contraception Requirements, from Day 0 until 16 weeks after the last dose of investigational product.
    5. Liver function (most recent values available before transplantation): ALT < 2xULN; bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    6. Immunosuppressants: at the time of transplantation, planned to receive a combination of immunosuppressants including basiliximab, mycophenolate mofetil, tacrolimus, prednisolone.
    E.4Principal exclusion criteria
    1. Donor characteristics: receiving a kidney allograft from a donor with any of the following characteristics
    a.cold ischemic time exceeding 36 hours
    b.age < 5 years old
    c.for donors after brain death (DBD), age >70 years old,
    d. for donors after cardiac death (DCD) age > 70 years old.
    e.ABO blood type incompatible against the recipient
    f.0 0 0 HLA-A -B -DR mismatch against the recipient by NHSBT criteria
    g.T- and/or B-cell positive crossmatch by complement dependent cytotoxicity or flow cytometry against the recipient

    Note: - (In some situations it may be that a pre existing T- and/or B-cell positive crossmatch by complement dependant cytotoxicity and flowcytometry against the recipient will only be fully revealed immediately after transplant; in such situations they will be recorded as having met exclusion criteria and withdraw from further involvement in the study.

    h.serology positive for hepatitis B (except hepatitis B surface antibody and prior vaccination), hepatitis C or human immunodeficiency virus (HIV)

    2. Transplant other than kidney: has previously received a hematopoietic stem cell/marrow transplant or an organ transplant other than a kidney (with the exception of corneal transplantation)
    3. Planned immunosuppressant regimen: are being considered for steroid-free or alemtuzumab induction
    4.Prior therapy at any time: has ever received any of the following:
    a. B-cell targeted therapy (e.g., rituximab, other anti-CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI fragment, crystallizable (Fc), or belimumab)
    5. 364 Day prior therapy: has received any of the following within 364 days before Day 0:
    a.Cyclophosphamide
    b. Abatacept
    c. A biologic investigational agent other than B-cell targeted therapy [e.g.,
    abetimus sodium, anti CD40L antibody (e.g., BG9588/ IDEC 131;
    investigational agent applies to any drug not approved for sale in the country in which it is being used]
    6. 90 Day prior therapy: has received any of the following within 364 days before Day 0:
    a. Anti-TNF or anti-IL-6 therapy (e.g., adalimumab, etanercept, infliximab,
    tocilizumab)
    b. Interleukin-1 receptor antagonists (e.g., anakinra)
    c. IVIG
    d. Plasmapheresis, leukapheresis
    7. 60 Day prior therapy: has received any of the following within 60 days before Day 0:
    a. A non-biologic investigational agent (investigational agent applies to any drug not approved for sale in the country in which it is being used)
    b. Any new immunosuppressive/immunomodulatoryagent; tacrolimus, MMF,
    and corticosteroids are permitted. Inhaled steroids and new topical
    immunosuppressive agents (e.g., eye drops, topical creams) are also allowed.
    8. 30 Day prior therapy: has received any of the following within 30 days before Day 0:
    a. A live vaccine
    b. An increase in dose of an immunosuppressive/immunomodulatory agent
    (decreases in dose or discontinuations are permitted). Increases in doses of
    tacrolimus, MMF, and corticosteroids are permitted.
    9. Malignancy: has a history of malignancy in the past 5 years except for
    adequately treated cancers of the skin (basal or squamous cell) or carcinoma in
    situ of the uterine cervix.
    Please see Protocol page 32 for complete exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline in naïve B cells from baseline to Week 24
    • AEs and SAEs, including AEs of special interest (opportunistic infections, malignancies, hypersensitivity and infusion reactions, all cause mortality and suicidality)
    • Incidence and severity of infections
    • Change from baseline and number of subjects outside the normal range for blood pressure, heart rate, and temperature
    • Change from baseline and number of subjects outside the normal range for clinical chemistry and haematology parameters, with particular attention to white blood cell count and immunoglobulin levels
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Weeks 1, 2, 4, 8, 12, 16, 20, 24 (End of Treatment), 36 (Safety Follow-up), and Week 52 (Exit Visit)
    E.5.2Secondary end point(s)
    • Percent change from baseline in memory B cells
    •Activated memory B cells, transitional B cells
    • Activated T cells, regulatory T cells, and ratio of activated: regulatory T cells
    • All HLA-specific and donor HLA-specific antibody levels
    • Proportion of subjects with episodes of acute rejection
    • Serum creatinine
    • Estimated glomerular filtration rate (eGFR)
    • Immunosuppressant/corticosteroid use
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening, Weeks 1, 2, 4, 8, 12, 16, 20, 24 (End of Treatment), 36 (Safety Follow-up), and Week 52 (Exit Visit)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.6.11Pharmacogenomic Yes
    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 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
    The end of the study is defined as the last subject’s last visit (LSLV). The last visit will be at Week 52 for subjects irrespective of whether they complete all scheduled infusions.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state20
    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 study because other treatment options are available.
    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 Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-08
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