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    Summary
    EudraCT Number:2015-005543-14
    Sponsor's Protocol Code Number:CTU/2013/096
    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:2018-11-19
    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 number2015-005543-14
    A.3Full title of the trial
    Safety and efficacy of Belimumab After B cell depletion therapy in systemic LUPUS erythematosus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of Belimumab After B cell depletion therapy in systemic LUPUS erythematosus – BEAT LUPUS
    A.3.2Name or abbreviated title of the trial where available
    BEAT LUPUS
    A.4.1Sponsor's protocol code numberCTU/2013/096
    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 College London
    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 supportResearch Costs Arthritis Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBRC Funding Costs
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Comprehensive Clinical Trials Unit, University College London
    B.5.2Functional name of contact pointDeputy Director
    B.5.3 Address:
    B.5.3.1Street AddressGower Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1E 6BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076795691
    B.5.6E-mailsusan.tebbs@ucl.ac.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 Belimumab
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    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
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 20.0
    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, efficacy, and immunological effects of anti-BAFF treatment Belimumab in lupus patients after B cell depletion therapy.
    E.2.2Secondary objectives of the trial
    1. Anti-dsDNA antibody levels at 24 and 64 weeks.
    2. Incidence of adverse events
    3. Incidence of infections
    4. Incidence of flare as defined as BILAG A or 2 B flares
    5. Time to flare as defined as BILAG A or 2 B flares
    6. Proportion of patients with a BILAG A or 2 B flare within 24, 52 and 64 weeks after randomisation.
    7. SLEDAI 2000 at 52 weeks
    8. Subject Global Assessment of Disease Activity (SGADA) at 52 weeks
    9. C3 and C4 levels
    10. Immunoglobulin levels
    11. BAFF (measurement of RNA from whole blood).
    12. Cumulative glucocorticoids dose
    13. Proportion of patients decreasing the steroid dose by 50% without flaring, or if below 10mg/day reduce to 5mg/day or the proportion of patients who discontinue glucocorticoids with stable disease.
    14. Lupus Quality of Life (Lupus QoL), SF-36 and EQ5D
    15. C-SSRS (suicide assessment)
    16. Kinetics of B cell repopulation, B and T cell phenotype and function during repopulation using Flow Cytometry (experimenta
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age between 18 and 75 years
    2. Patients with 4 or more criteria for SLE according to the American College of Rheumatology (ACR) 1997 criteria or SLICC 2012 criteria or biopsy proven lupus nephritis with one additional supportive test on at least two occasions (positive ANA, anti-dsDNA antibodies or anti-Sm antibodies)
    3. History of anti-dsDNA antibodies detectable at least once in the past.
    4. Patients have received the first infusion of this cycle of B cell depletion therapy (rituximab) 4-6 weeks before randomisation (week 0, see participant timeline).
    5. No contraindications to the use of belimumab.
    6. Ability to provide informed consent
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Severe “critical” SLE flare defined as BILAG A flare in CNS system or any SLE manifestation requiring more immunosuppression than allowed within the protocol in the physician's opinion
    2. Pregnancy and/or Breast Feeding patients
    3. At risk of pregnancy and unwilling to use an acceptable form of birth control contraception (see section 6.3.1.4)
    4. Prior use of Belimumab, Atacicept or any biologic therapy (except rituximab, but no other B cell depleting therapies)
    5. Participation in any other interventional trial within the last 6 months
    6. eGFR <30mls/min at screening
    7. Active infections, including but not limited to:
    i. Current or past infection with hepatitis B or C as defined by:
    A. Hepatitis B surface antigen positive
    B. Hepatitis B surface antibody positive and hepatitis B core antibody positive
    C. Hepatitis C antibody positive
    ii. Historically positive HIV test or test positive at screening for HIV
    iii. Active TB.
    8. Infection history:
    i. Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
    ii. Hospitalization for treatment of infection within 60 days of Day 0
    iii. Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0
    9. Receipt of a live-attenuated vaccine within 3 months of week 0 (see participant timeline)
    10. In the investigator’s opinion, patients that are at high risk for infection (including but not limited to in dwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent severe urinary tract infection)
    11. IgG levels below 4.0 g/L, IgA level < 10 mg/dL (IgG and IgA test must be performed no more than 10 days before study drug commenced for the second inclusion/exclusion criteria assessment at week 0)
    12. Primary immunodeficiency
    13. History of malignant neoplasm within the last 5 years
    14. History of cervical dysplasia CIN Grade III cervical high risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) within the past 3 years. The patient will be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality has been effectively treated >1 year ago)
    15. Severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, pulmonary, cardiac, or neurological disease or, in the investigator’s opinion, any other concomitant medical condition or significant abnormal laboratory value that places the participant at risk by participating in this study with the exception of diseases or conditions related to active SLE.
    16. Comorbidities currently requiring systemic corticosteroid therapy.
    17. Evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator’s judgement, pose a significant risk.
    18. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
    19. Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0
    20. White blood cells (WBC) <1.5 x 109/L, Neutrophils <1 x 109/L measured up to 10 days before week 0 (study drug commenced)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is Anti dsDNA-antibody levels at 52 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 52 weeks
    E.5.2Secondary end point(s)
    1. Anti-dsDNA antibody levels at 24 and 68 weeks.
    2. Incidence of adverse events
    3. Incidence of infections
    4. Incidence of flare as defined as BILAG A or 2 B flares
    5. Time to flare as defined as BILAG A or 2 B flares
    6. Proportion of patients with a BILAG A or 2 B flare within 24, 52 and 64 weeks after randomisation.
    7. SLEDAI 2000 at 52 weeks
    8. Subject Global Assessment of Disease Activity (SGADA) at 52 weeks
    9. C3 and C4 levels
    10. Immunoglobulin levels
    11. BAFF (measurement of RNA from whole blood).
    12. Cumulative glucocorticoids dose
    13. Proportion of patients decreasing the steroid dose by 50% without flaring, or if below 10mg/day reduce to 5mg/day or the proportion of patients who discontinue glucocorticoids with stable disease.
    14. Lupus Quality of Life (Lupus QoL), SF-36 and EQ5D
    15. C-SSRS (suicide assessment)
    16. Kinetics of B cell repopulation, B and T cell phenotype and function during repopulation using Flow Cytometry.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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 concerned16
    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 years3
    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 years3
    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: 50
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    Belimumab is not routinely permitted for use in this patient population according to NICE guidelines; therefore no provisions can be made for the use of Belimumab once the research finishes.
    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 Decision2016-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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