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    Summary
    EudraCT Number:2006-005177-21
    Sponsor's Protocol Code Number:HGS1006-C1056
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-28
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-005177-21
    A.3Full title of the trial
    A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)
    A.3.2Name or abbreviated title of the trial where available
    BLISS-76
    A.4.1Sponsor's protocol code numberHGS1006-C1056
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHuman Genome Sciences, Inc.
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 HGS1006
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeHGS1006
    D.3.9.3Other descriptive nameLymphoStat-B TM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120 and 400
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder for solution for injection
    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 (SLE)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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 efficacy of belimumab in subjects with SLE.

    To evaluate the safety and tolerability of belimumab in subjects with SLE.

    To evaluate the impact of belimumab on quality of life in subjects with SLE.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The Pharmacogenetic Research is contained in Appendix 12 of the Protocol (22 August 2006, protocol amendment 01)

    Objectives:
    To establish the relationship between genetic variants and the pharmacokinetics of belimumab.

    To establish the relationship between genetic variants and the safety and tolerability of belimumab.

    To establish the relationship between genetic variants and the efficacy of belimumab.
    E.3Principal inclusion criteria
    1. Are at least 18 years of age.
    2. Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) criteria.
    3. Have active SLE disease defined as a SELENA SLEDAI score of greater than or equal to 6 at screening.
    4. Have unequivocally positive anti-nuclear antibody (ANA) test results 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. A positive ANA test is defined as an ANA titer of greater than or equal to 1:80 and/or a positive anti-dsDNA (greater than or equal to 30 IU/mL) serum antibody.
    OR
    • One positive historical test result and 1 positive test result during the screening period.
    Historical documentation of a positive test of ANA (eg, ANA by HEp-2 titer or ELISA) or anti-dsDNA (eg, anti-dsDNA by Farr assay or ELISA) 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).
    5. Are on a stable SLE treatment regimen consisting of any of the following medications (alone or in combination) for a period of at least 30 days prior to Day 0 (ie, day of 1st dose of study agent)
    • Corticosteroids (prednisone or prednisone equivalent, up to 40 mg/day):
    - For subjects on SLE combination therapy, their stable steroid dose must be fixed within the range of 0 to 40 mg/day (prednisone or prednisone equivalent).
    For subjects whose only SLE treatment is steroids, their stable steroid dose must be fixed within the range of 7.5 to 40 mg/day (prednisone or prednisone equivalent).
    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 (eg, tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine or thalidomide.
    • Anti-malarials (eg, hydroxychloroquine, chloroquine, quinacrine).
    • Non-steroidal anti-inflammatory drugs.
    •Pre-existing SLE medications must be stable for at least 30 days prior to Day 0.
    • Corticosteroids may be added as new medication 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.
    6. Subjects on angiotensin pathway antihypertensives (eg, ACE inhibitors, angiotensin receptor blockers [ARBs]) must be on a stable regimen for a period of at least 30 days prior to Day 0.
    7. Subjects on HMG CoA reductase inhibitors (“statins”, such as simvastatin, rosuvastatin, atorvastatin, lovastatin, pravastatin, fluvastatin) must be on a stable regimen for a period of at least 30 days prior to Day 0.
    8. A female subject is eligible to enter the study if she is:
    • Not pregnant or nursing;
    • Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
    • Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to 1 of the following:
    Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 8 weeks after the last dose of study agent; or
    Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent and 8 weeks after the last dose of study agent:
    • Implants of levonorgestrel;
    •Injectable progesterone;
    • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year;
    • Oral contraceptives (either combined or progesterone only);
    • Double barrier method: Condom, cervical cap or diaphragm with spermicidal agent;
    •Transdermal contraceptive patch;
    • Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for the female subject.
    9. A male subject is eligible to enter the study if he agrees to use effective contraception throughout the study and for 3 months after the last dose of study agent.
    10. Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information) and comply with the study protocol procedures (including required study visits).


    E.4Principal exclusion criteria
    . Have received treatment with any B cell targeted therapy (eg rituximab, other anti-CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc or belimumab) at any time
    2. Have received any of the following within 364 days of Day 0:
    Abatacept; A biologic investigational agent other than B cell targeted therapy (eg abetimus sodium, anti-CD40L antibody [BG9588/ IDEC-131])(Investigational agent applies to any drug not approved for sale in the country in which it is being used)
    3. Have required 3 or more courses of systemic corticosteroids for concomitant conditions (eg asthma, atopic dermatitis) within 364 days of Day 0 (Topical/inhaled steroids permitted)
    4. Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
    5. Have received any of the following within 90 days of Day 0:
    Anti-TNF therapy; Interleukin-1 receptor antagonist (anakinra); Intravenous immunoglobulin (IVIG); High dose prednisone (>100 mg/day); 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, HMG CoA reductase inhibitor (eg statin) or angiotensin pathway antihypertensive (eg ACE inhibitor, angiotensin receptor blocker). (Inc Criteria 5, 6 & 7)
    Note: New inhaled steroids and new topical immunosuppressive agents (eg eye drops, topical creams) are allowed.Any NSAID use for <1 week is allowed
    Any steroid injection (intramuscular, intraarticular or intravenous)
    7. Have received any of the following within 30 days of Day 0:
    A live vaccine; Change in dose of a corticosteroid, other; immunosuppressive/immunomodulatory agent, antimalarial, NSAID, HMG CoA reductase inhibitor (statin) or angiotensin pathway antihypertensive (eg ACE inhibitor, angiotensin receptor blocker) (Inc Criteria 5, 6 & 7)
    8. Have severe lupus kidney disease (defined by proteinuria >6g/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine >2.5mg/dL), have active nephritis, or have required hemodialysis or high-dose prednisone (>100 mg/day) within 90 days of Day 0
    9. 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
    10. Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant
    11. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (ie cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which in the opinion of the PI could confound the results of the study or put the subject at risk
    12. Have a planned surgical procedure or a history of any other medical disease
    (eg cardiopulmonary), lab abnormality or condition that in the opinion of the PI makes the subject unsuitable for the study
    13. Have a history of malignant neoplasm within the last 5 years except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the cervix
    14. Have required management of acute or chronic infections as follows:
    Currently on any suppressive therapy for a chronic infection (such as tuberculosis,
    pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical
    mycobacteria)
    Hospitalization for treatment of infection within 60 days of Day 0
    Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0
    15. Have current drug/alcohol abuse or dependence or history of drug/alcohol abuse or dependence within 364 days prior to Day 0 (Appendix 2)
    16. Have a historically positive test or test positive at screening for HIV antibody, hepatitis B surface antigen or hepatitis C antibody.
    17. Have an IgA deficiency (IgA level <10mg/dL).
    18. Have a Grade 3 or greater lab abnormality based on the protocol toxicity scale in Appendix 13 the following 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 3/4 proteinuria (≤6 g/24 hour equivalent by spot urine protein to creatinine ratio allowed)
    Stable Grade 3 hypoalbuminemia due to lupus nephritis and not related to liver disease or malnutrition
    Stable Grade 3 gamma glutamyl transaminitis 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 WBC count.
    19. Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is response rate at Week 52.
    • A response is defined as:
    • Greater than or equal to a 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 at the time of assessment (ie, at 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 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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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) Yes
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 327
    F.4.2.2In the whole clinical trial 810
    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 that complete the trial are eligible for a continuation trial in which they may continue to receive treatment with belimumab until a marketing authorisation application is filed or until the sponsor decides not to develop the product further
    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 Decision2007-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
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