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    Summary
    EudraCT Number:2011-000368-88
    Sponsor's Protocol Code Number:BEL114055
    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:2012-04-18
    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 number2011-000368-88
    A.3Full title of the trial
    A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age
    A.3.2Name or abbreviated title of the trial where available
    Belimumab in pediatric patients with SLE
    A.4.1Sponsor's protocol code numberBEL114055
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/183/2016
    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 and 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 pointGSK Clinical Helpdesk Support
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford Middlesex,
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408007839733
    B.5.5Fax numberNot Applicable
    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 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 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
    Systemic Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    Lupus
    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 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluate the safety and tolerability of belimumab in the pediatric SLE population
    • Evaluate the pharmacokinetics of belimumab in the pediatric SLE population.
    • Evaluate the efficacy of belimumab in the pediatric SLE population
    • Evaluate the effects of belimumab on the quality of life in the pediatric SLE population.
    E.2.2Secondary objectives of the trial
    •To evaluate the sustained efficacy and safety of belimumab in the pediatric SLE population
    •Evaluate the pharmacokinetics of belimumab in the pediatric SLE population
    •Evaluate the effects of belimumab on the quality of life and fatigue in the pediatric SLE population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    1. Are 5 to 17 years of age
    2. Have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE
    3. Have active SLE disease defined as a SELENA SLEDAI score ≥ 8 at screening.
    4. Have unequivocally positive autoantibody test results defined as an ANA titre ≥ 1:80
    and/or a positive anti-dsDNA (≥ 30 IU/mL) serum antibody test from 2 independent
    Time points as follows:
    •Positive test results from 2 independent time points within the study screening
    period. Screening results must be based on the study’s central laboratory results.
    OR
    •One positive historical test result and 1 positive test result during the screening period.
    Historical documentation of a positive test of ANA (e.g., ANA by HEp-2 titre) or antidsDNA (e.g., anti-dsDNA by Farr assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive vs. negative OR negative, equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory’s reference range are acceptable; borderline values will not be accepted.
    5. Are on a stable SLE treatment regimen.
    “Stable treatment at baseline” consists of any of the following medications (alone or in combination) at a fixed dose for a period of at least 30 days prior to Day0:
    • Corticosteroids (prednisone or prednisone equivalent up to 0.5 mg/kg/day):
    • For subjects on SLE combination therapy, their stable steroid dose must be fixed within the range of 0 to 0.5mg/kg/day (prednisone or prednisone equivalent)
    • For subjects whose only SLE treatment is steroids, their stable steroid
    dose must be fixed within the range of 0.1-0.5mg/kg/day.
    • For those subjects on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose.
    • Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g. tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine or thalidomide.
    • Anti-malarials (e.g. hydroxychloroquine, chloroquine, quinacrine)
    • Non-steroidal anti-inflammatory drugs (NSAIDs)
    Note:
    • Pre-existing SLE medications must be stable for at least 30 days prior to Day 0.
    • Corticosteroids may be added as new medications or their doses adjusted only up to 30 days prior to Day 0.
    • New SLE therapy other than corticosteroids must not be added within 60 days of Day 0.

    (For the full section on Inclusion criteria, please refer to the Protocol on Page 28-31)
    E.4Principal exclusion criteria
    1. Have received treatment with belimumab (BENLYSTA™) at any time
    2. Have received any of the following within 364 days of Day 0:
    •Treatment with any B-cell targeted therapy (e.g., rituximab, other anti-CD20 agents, anti- CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc)
    •Abatacept.
    A biologic investigational agent
    3. Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 364 days of Day 0 (Topical or inhaled steroids are permitted).
    4. Have received intravenous IV cyclophosphamide within 90 days of Day 0.
    5. Have received any of the following within 90 days of Day 0:
    • Anti-TNF therapy (e.g., adalimumab, etanercept, infliximab).
    • Interleukin-1 receptor antagonist (anakinra).
    • Intravenous immunoglobulin (IVIG).
    • Plasmapheresis.
    6. Have received any of the following within 60 days of Day 0:
    • A non-biologic investigational agent
    • Any new immunosuppressive/immunomodulatory agent, anti-malarial, NSAID, (See Inclusion Criteria #5)
    Note: New inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed. Any NSAID use for < 1 week is allowed
    • High dose prednisone (> 1.5 mg/kg/day) or equivalent or any steroid injection (IM, IA, IV)
    7. Have received any of the following within 30 days of Day 0:
    • A live vaccine.
    •A change in dose of a corticosteroid, other immunosuppressive/ immunomodulatory agent, anti-malarial, NSAID, (See Inclusion Criteria #5)
    8. Have active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0.
    9. Have required renal replacement therapy (e.g. hemodialysis, peritoneal dialysis) within 90 days of Day 0 or be currently on renal replacement therapy
    10. Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 ml/min.
    11. Have severe nephritis defined as a significant worsening of renal disease manifested by the presence of urinary sediments and other lab abnormalities that, in the opinion of the study investigator, may lead to the subject requiring IV cyclophosphamide, MMF or high dose IV corticosteroids during the first 6 months of the trial.View protocol for further information.
    12. Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or
    hematopoetic stem cell/marrow transplant.
    13. Have clinical evidence of significant, unstable or uncontrolled, acute or chronic
    diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the
    study or put the subject at undue risk.
    14. Have a planned surgical procedure or a history of any other medical disease (e.g. cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
    15. Have a history of malignant neoplasm within the last 5 years.
    16. Subjects => 12 years of age who have evidence of serious suicide risk including any
    history of suicidal behaviour in the last 6 months and/or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (Refer to Appendix 12 within the protocol) in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.
    17. Have a history of a primary immunodeficiency
    18. Have an IgA deficiency (IgA level < 10 mg/dL).
    19. Have required management of acute or chronic infections, as follows: please see protocol for further information.
    20. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol
    abuse or dependence within 364 days prior to Day 0.
    21. Have a historically positive HIV test or test positive at screening for HIV.
    22. Hepatitis B: Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs as follows: Please see protocol for further information.
    23. Hepatitis C: Positive test for Hepatitis C antibody confirmed on an additional blood sample by RNA PCR assay. Subjects who are positive for Hepatitis C antibody and negative when the Hepatitis C RNA-PCR assay is performed on an additional sample will be eligible to participate. Please view the protocol for updated information.
    24. Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale
    except for the following that are allowed: Please view protocol for further information.
    25. Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
    26. Children in Care: A Child in Care (CiC) Please view protocol for further information.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is SLE
    Responder Index (SRI) response rate at
    Week 52 which is defined as:
    ≥ 4 point reduction from baseline in SELENA SLEDAI score,
    AND
    No worsening (increase of < 0.30 points from baseline) in Physician’s Global Assessment PGA),
    AND
    No new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    1. Proportion of subjects meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE using two different PRINTO/ACR Juvenile SLE Response Evaluation definitions of improvement
    a. At least 50% improvement in any 2 of 5 endpoints below and no more than 1 of the remaining worsening by more than 30%
    b. At least 30% improvement in 3 of 5endpoints below and no more than of the remaining worsening more than 30%.
    I. Percent change in Parent’s Global Assessment (ParentGA) at Week 52.
    II. Percent change in Physician’s Global Assessment (PGA) at Week 52.
    III. Percent change in SELENA SLEDAI score at Week 52.
    IV. Change in PedsQL physical functioning domain at Week 52
    V. Percent change in 24 hour proteinuria at Week 52 (g/24hour equivalent by spot urine protein to creatinine ratio).
    2. Proportion of subjects with a sustained SRI response
    3. Proportion of subjects with a sustained ParentGA response
    4. Safety of belimumab
    5. PK comparison with Adult PK
    6. PedsQL Multidimensional Fatigue Scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    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 No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open label long-term extension
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Italy
    Mexico
    Netherlands
    Peru
    Poland
    Russian Federation
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years14
    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 years14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    Please refer to Protocol page 31
    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 35
    F.4.2.2In the whole clinical trial 100
    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)
    As per protocol
    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 Decision2012-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-13
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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