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    Summary
    EudraCT Number:2018-004645-16
    Sponsor's Protocol Code Number:200908
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-29
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004645-16
    A.3Full title of the trial
    A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of belimumab in children with lupus
    A.3.2Name or abbreviated title of the trial where available
    Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE
    A.4.1Sponsor's protocol code number200908
    A.5.4Other Identifiers
    Name:PLUTO-SC/ 200908Number:PLUTO-SC/ 200908
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/313/2020
    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 pointGSK Clinical Support Help Desk
    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+44 0800 783 9733
    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
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline (Ireland) Limited
    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 nameBelimumab
    D.3.2Product code GSK1550188
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 codeGSK1550188
    D.3.9.3Other descriptive nameLymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus - SLE
    E.1.1.1Medical condition in easily understood language
    Lupus - SLE
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    To characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants.

    -To characterize the pharmacodynamic profile of belimumab 200 mg SC in pediatric SLE participants.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in Parts A and B of the study only if all of the following criteria apply:
    Age
    1. Participant must be between 5 and 17 years of age inclusive, at the time of Day 1.
    Type of Participant and Disease Characteristics
    2. Participants who meet the 1997 American College of Rheumatology (ACR) criteria for the classification of SLE (Appendix 8) of the protocol
    a. Have or have had in series 4 or more of the 11 ACR criteria for the classification of SLE
    3. Have active SLE disease defined as a SELENA SLEDAI score ≥6 at screening (Appendix 9) of the protocol.
    4. Have documented positive autoantibody test results within the study screening period, defined as an ANA titre ≥ 1:80 and/or a positive anti-dsDNA (≥30 IU/mL) serum antibody test based on EITHER the study’s central laboratory results OR the
    local laboratory results. 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) administered for a period of at least 30 days prior to Day 1:
    - Corticosteroids (prednisone or prednisone equivalent up to 0.5 mg/kg/day):
    - For those participants 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)
    - New SLE therapy must not be added within 30 days of Day 1.
    Weight
    6. Body weight ≥15 kg.
    Sex
    7. Male and/or female
    Contraceptive use by men or women should be consistent with local regulations
    regarding the methods of contraception for those participating in clinical studies.
    Male Participants
    No contraceptive measures are required for male participants.
    Female participants:
    A female participant is eligible to participate if she is not pregnant or breastfeeding,
    and at least one of the following conditions applies:
    - Is not a woman of childbearing potential (WOCBP) (See Appendix 4) of the protocol
    OR
    - Is a WOCBP and is using a contraceptive method that is highly effective, with a
    failure rate of <1%, as described in Appendix 4 during the belimumab treatment
    period and for at least 16 weeks, corresponding to the time needed to eliminate
    any study intervention(s) (e.g., 5 terminal half-lives), after the last dose of study
    intervention. The investigator should evaluate the effectiveness of the
    contraceptive method in relationship to the first dose of study intervention.
    - A WOCBP must have a negative highly sensitive [Appendix 2] of the protocol pregnancy test (serum or as required by local regulations) within 35 days before the first dose of belimumab.
    - The investigator is responsible for review of medical history, menstrual history, and
    recent sexual activity to decrease the risk for inclusion of a woman with an early
    undetected pregnancy.
    Informed Consent
    8. Participant signs and dates a written age appropriate assent form (in accordance with applicable regulations) and the parent or legal guardian (or emancipated minor) that has the ability to understand the requirements of the study, provides written informed consent (including consent for the use and disclosure of research-related health information) that the participant will comply with the study protocol procedures (including required study visits).
    E.4Principal exclusion criteria
    Participants are excluded from Parts A and B of the study if any of the following criteria apply:
    Medical Conditions
    1. Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula [Schwartz, 2009] of less than 30 mL/min.
    2. Have acute severe nephritis defined as significant renal disease (e.g., the presence of urinary sediments and other lab abnormalities) that, in the opinion of the study investigator, may lead to the participant requiring induction therapy during the first 12 weeks of the trial.
    Note: Clinically stable lupus nephritis which can be managed with medications allowed in the study will not exclude participants from participating in the trial (nor will any maximum level of proteinuria exclude participants). Clinical assessment and medical management of nephritis will be at the discretion of the study investigator.
    3. Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoetic stem cell/marrow transplant.
    4. 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 investigator, could confound the results of the study or put the participant at undue risk.
    5. 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 investigator, makes the participant unsuitable for the study.
    6. Have a history of malignant neoplasm within the last 5 years.
    7. Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months, or who in the investigator’s opinion, pose a significant suicide risk.
    8. Have a history of a primary immunodeficiency.
    9. Have an IgA deficiency (IgA level <10 mg/dL).
    10. Have acute or chronic infections requiring management, as follows:
    -Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
    -Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals,
    or anti-parasitic agents) for infection within 60 days of Day 1.
    11. Have a Grade 3 or greater laboratory abnormality based on the protocol defined Adverse Event and Laboratory Value Severity Grade scale (Appendix 2, Section 10.2.1) of the protocol except for the following that are allowed:
    - Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.
    -Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and
    not related to liver disease or anti-coagulant therapy.
    - Stable Grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver
    disease or malnutrition.
    - Any grade proteinuria.
    - Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes or viral hepatitis. If present, any abnormalities in the ALT and or AST must be ≤ Grade 2.
    - Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE.
    12. Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies or to any of the excipients of the study drug.
    Prior/Concomitant Therapy
    13. Have ever received treatment with belimumab (BENLYSTA).
    14. Have received any of the following within 364 days of Day 1:
    - 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.
    - Any biologic investigational agent
    15. Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 90 days of Day 1 (topical or inhaled steroids are permitted).
    16. Have received any of the following within 90 days of Day 1:
    - Anti-TNF therapy (e.g., adalimumab, etanercept, infliximab).
    - Interleukin-1 receptor antagonist (anakinra).
    - Intravenous immunoglobulin (IVIG).
    - Plasmapheresis.
    17. Have received any of the following within 30 days of Day 1:
    -Intravenous (IV) cyclophosphamide.
    - A non-biologic investigational agent (30 day window OR 5 half-lives, whichever is greater).
    - Any new immunosuppressive/immunomodulatory agent.
    - High dose prednisone or equivalent (>1.5 mg/kg/day) or any intramuscular or
    intravenous steroid injection.
    - Note: New inhaled steroids, intraarticular steroids, and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed.
    Any NSAID use for > 1 week is allowed.
    E.5 End points
    E.5.1Primary end point(s)
    - Observed belimumab concentrations at Week 12.
    - Steady-state PK parameters: Cavg (AUC), Cmax, Cmin (based on population PK estimates).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    -Incidence of adverse events, serious adverse events and adverse events of special interest through Week 52.

    -Change from baseline in biomarkers (C3/C4, anti-dsDNA, B cell subsets, and immunoglobulins) at Weeks 12 and 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Biomarkers: Weeks 12 and 52
    -AEs: through week 52

    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Japan
    Mexico
    United States
    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 years10
    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 years10
    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: 24
    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: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 19
    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 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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 24
    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)
    Post-treatment follow-up assessments at 8 and 16 weeks after the last dose of SC belimumab
    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 Decision2019-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-29
    P. End of Trial
    P.End of Trial StatusOngoing
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