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    Summary
    EudraCT Number:2025-000106-42
    Sponsor's Protocol Code Number:213560
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-04-22
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2025-000106-42
    A.3Full title of the trial
    Protocol Title: A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients with Active Systemic Lupus Erythematosus (SLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open label study of Belimumab plus standard therapy in Chinese Paediatric patients with active SLE
    A.3.2Name or abbreviated title of the trial where available
    Open label study of Belimumab plus standard therapy in Chinese Paediatric patients with active SLE
    A.4.1Sponsor's protocol code number213560
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05917288
    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 Limited
    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 Limited
    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 Limited
    B.5.2Functional name of contact pointHafsa Khan
    B.5.3 Address:
    B.5.3.1Street Address79 New Oxford Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1A 1DG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 20 8047 9534
    B.5.6E-mailhafsa.x.khan@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.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Powder for solution for infusion [120 mg/vial]
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder for solution for injection/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.3.9.3Other descriptive nameLymphoStat-B (LSB), monoclonal anti-Blys, LSB
    D.3.9.4EV Substance CodeSUB25607
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Systemic Lupus Erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    Lupus
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    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 the safety and efficacy of belimumab IV in Chinese pediatric participants with SLE.
    E.2.2Secondary objectives of the trial
    - To evaluate safety and tolerability of belimumab IV in Chinese pediatric participants with SLE.
    - To evaluate the efficacy of belimumab IV in Chinese pediatric participants with SLE.
    - To evaluate the PK of belimumab (10 mg/kg) IV in Chinese pediatric participants with SLE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type of Participant and Disease Characteristics
    1.Participants have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE (Section 10.7: Appendix 7).
    2.Participant’s age is 5 to 17 years at the time of informed consent.
    3.Have active SLE disease defined as a SELENA SLEDAI score ≥ 8 at screening (SELENA SLEDAI scoring see Section 10.8: Appendix 8).
    4.Have unequivocally positive autoantibody test results defined as an ANA titre ≥ 1:80 and/or a positive anti-dsDNA serum antibody test.
    5.Are on a stable SLE therapy at Baseline.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:

    1. Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 mL/min.
    2. Have acute severe nephritis defined as a significant worsening of renal disease
    3. Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE
    4. Have a history of a primary immunodeficiency.
    5. Have an IgA deficiency (IgA level <10 mg/dL).
    6. Have acute or chronic infections requiring management,
    7. Have recent infections that, in the opinions of the investigator, makes the participant unsuitable for the study or could put the participant at undue risk.
    8. Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months or who in the investigator's judgment, poses a significant suicide risk.
    Prior/Concomitant Therapy
    9. Have received treatment with belimumab at any time.
    10. 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.
    11. Have required renal replacement therapy (e.g. haemodialysis, peritoneal dialysis) within 90 days of Day 0 or be currently on renal replacement therapy
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Incidence of adverse events of special interest (AESIs) through 52 weeks:
    • All infections of special interest, including serious infections of special interest and opportunistic infections
    • Infusion-related systemic reactions and anaphylactic reactions
    • Depression, suicidality
    • Malignancies



    Efficacy
    Incidence of patients with ≥4-point reduction from Baseline to Week 52 in SELENA SLEDAI
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 Weeks
    E.5.2Secondary end point(s)
    Incidence of AEs through 52 Weeks
    Incidence of SAEs through 52 weeks
    Incidence of patients with 4-point reduction from Baseline in SELENA SLEDAI by visit
    Change from Baseline to Week 52 in Physician Global Assessment (PGA)
    Change from Baseline to Week 52 in Parent Global Assessment (ParentGA)
    Change from Baseline in daily prednisone equivalent dose at Week 52
    Time to first flare/ first severe flare over 52 weeks
    Median belimumab concentration levels at Day 0, 7 and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    The PK will be evaluated with respect to clearance, volume of distribution and half-life, and individual steady state exposures Cmin, Cavg, Cmax and AUC
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 52/ Median belimumab concentration levels at Day 0, 7 and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days23
    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: 67
    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: 16
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 51
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 67
    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)
    Actual treatment:Belimumab (10mg/kg) was administered IV over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through the Week 48 (Day 336) visit. All participants continued to receive their standard SLE therapy with restrictions on the changes that were permitted throughout the 52-week observational period.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Not Applicable
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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