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    Summary
    EudraCT Number:2015-000400-26
    Sponsor's Protocol Code Number:201842
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-01
    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
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-000400-26
    A.3Full title of the trial
    A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome
    A.4.1Sponsor's protocol code number201842
    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 R&D 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 R&D
    B.4.2CountryUnited States
    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 AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number +44 0800 783 9733
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 MabThera (Rituximab)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameMabThera (Rituximab)
    D.3.4Pharmaceutical form Concentrate 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameMABTHERA
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 Ltd.
    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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 nameHGS1006, LymphoStat-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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sjogrens disease
    E.1.1.1Medical condition in easily understood language
    Sjogren’s Syndrome
    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 10061664
    E.1.2Term Autoimmune disorder
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety and tolerability of anti-BLyS / anti-CD 20 coadministration therapy and anti-BLyS and anti-CD 20
    monotherapies
    E.2.2Secondary objectives of the trial
    -Clinical efficacy of anti-BLyS / anti-CD 20 co-administration therapy and anti-BLyS and anti-CD 20 monotherapies

    -Assessment of anti-BLyS / anti-CD 20 co-administration therapy and anti-BLyS and anti-CD 20
    monotherapies on tissue B-cells.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    AGE
    1. Age ≥18 years, at the time of signing the informed consent.

    TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
    2. Documented Primary Sjögren’s Syndrome by American European Consensus Group criteria including:
    - either SS-A or SS-B positive.
    3. Baseline unstimulated salivary flow >0.0 mL/min or evidence of glandular reserve function (stimulated baseline salivary flow >0.05 mL/min).
    4. Symptomatic oral dryness (≥5/10 on subject completed Numeric Response Scale)
    5. Systemically active disease, ESSDAI ≥5 points.

    OR (for sites in ITALY ONLY)
    Systemically active disease, ESSDAI≥5 points and with at least:
    a) 1 extraglandular domain moderate,
    OR
    b) 2 extraglandular domains low.

    SEX
    6. Male and female subjects; females of child bearing potential are eligible if using effective contraception:

    Female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotropin (hCG) test), not lactating, and at least one of the following conditions applies:

    a. Non-reproductive potential defined as:
    -Pre-menopausal females with one of the following:
    -Documented tubal ligation
    -Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
    -Hysterectomy
    -Documented Bilateral Oophorectomy

    - Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study; otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
    b. Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication up to Week 68 after Day 0.

    GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP)

    This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal intercourse on a long term and persistent basis.

    -Contraceptive subdermal implant that meets the SOP effectiveness
    criteria including a <1% rate of failure per year, as stated in the product
    label
    -Intrauterine device or intrauterine system that meets the SOP
    effectiveness criteria including a <1% rate of failure per year, as stated
    in the product label
    -Combined estrogen and progestogen oral contraceptive
    -Injectable progestogen
    -Contraceptive vaginal ring
    -Percutaneous contraceptive patches
    -Male partner sterilization with documentation of azoospermia prior to
    the female subject's entry into the study, and this male is the sole
    partner for that subject.

    These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label.

    The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

    OTHER CRITERIA
    8. For FRANCE ONLY, a subject will be eligible for inclusion in this study
    if he /she is either affiliated to or beneficiary of a social security
    category. It is the investigator's responsibility to ensure and to
    document (in source document - patient notes) that the patient is either
    affiliated to or beneficiary of a social security category.
    E.4Principal exclusion criteria
    CONCURRENT CONDITIONS/MEDICAL HISTORY
    1. Diagnosis of secondary Sjögren’s syndrome.
    2. Active life-threatening or organ-threatening complications of SS disease at the time of screening based on treating physician evaluation including but not restricted to (a) vasculitis with renal, digestive, cardiac, pulmonary or CNS involvement characterized as severe, (b) active CNS or PNS involvement requiring high dose steroids, (c) severe renal involvement defined by objective measures, (d) lymphoma.
    3. History of major organ transplant
    4. History of malignancy within past 5 years [with the exception of adequately treated: (a)cervical carcinoma Stage 1B or less, (b)non-invasive basal cell and squamous cell skin carcinoma].
    5. History of infection requiring long term systemic therapy including: (a)history of positive HIV serology, (b)positive serology for Hepatitis C (HCV), (c)positive serology for Hepatitis B (HB), defined as: (i) HB surface antigen positive (HBsAg+) OR (ii) HB core antibody positive (HBcAb+).
    6. Previous serious opportunistic or atypical infections or hospitalization for treatment of infection within 364 days of Day 0 or use of parenteral (IV or IM) antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 364 days of prior to Day 0.
    7. Patients in a severely immunocompromised state.
    8. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
    9. History of significant medical illness which in the opinion of the investigator would interfere with the study procedures and/or assessments - including but not limited to IgG4 disease or prior head or neck irradiation.
    10. Severe heart failure or other severe, uncontrolled cardiac disease.
    11. Tuberculosis (TB), defined as: (a)prior history of TB infection, (b)suspicion of TB infection or (c) current TB infection
    12. At risk of suicide, as indicated by a lifetime history of attempted suicide or significant suicidal ideation over the 6 months prior to the screening visit; or, if in the Investigator’s judgment, the subject is at risk for a suicide attempt.
    13. Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) - not otherwise explained - or confirmed PML.
    14. Electrocardiogram (ECG) showing a clinically significant abnormality at Screening or showing an average QTcB or QTcF interval ≥450 msec over 3 consecutive ECGs (refer to Section 7.4.5)
    15. ALT >2xULN and bilirubin >1.5xULN
    16. Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
    CONCOMITANT MEDICATIONS
    17. Use of systemic immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate, mizoribine, calcineurin inhibitors, sirolimus, 6-mercaptopurine, or thalidomide) within 60 days prior to Day 0.
    18. Have received cyclophosphamide within 180 days prior to Day 0.
    19. Have received anti-BLyS, anti-CD 20, anti-CD22 or anti-CD52 or any other B-cell depleting agent within 364 days prior to Day 0.
    20. Have received abatacept or any biologic agent within 180 day prior to Day 0
    21. Have received IVIG or plasmapheresis within 90 days prior to Day 0.
    22. Have received oral steroid >10 mg prednisone equivalent/day within 30 days prior to Day 0 or oral steroid >20 mg prednisone equivalent / day for a minimum of two consecutive weeks within 60 days prior to Day 0. Have received parenteral steroid within 60 days prior to Day 0.
    23. Have received a live vaccine within 30 days of Day 0.
    24. Current participation in any other interventional trial.
    25. Planned blood donation during the treatment and follow up periods of the study.
    RELEVANT HABITS
    26. Subjects who are unable or unwilling to administer, or to have a caregiver administer subcutaneous injections.
    27. Drug or alcohol abuse or dependence.
    CONTRAINDICATIONS
    28. History of hypersensitivity to belimumab and/or rituximab or known to have titers of human anti-mouse antibody or human anti-chimeric antibody or history of
    hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
    DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
    29. Have an IgA deficiency (IgA level <10 mg/dL).
    30. Any of the following screening laboratory values:
    -White blood cells (WBC) <2 x 109/L -Neutrophils <1.5 x 109/L -Circulating IgG <550mg/dl -Aspartate aminotransferase (AST) >2.0 times the upper limit of normal -Alkaline phosphatase (ALP) >1.5 times the upper limit of normal -Bilirubin >1.5 times the upper limit of normal -CD19+ B-lymphocyte counts <0.1 x 109/L (applies only to subjects previously exposed to B cell depleting therapies)
    31. For FRANCE ONLY, subjects with legal or administrative guardianship ("tutelle" or "curatelle"),or subjects deprived of liberty, or subjects receiving psychiatric care, or subjects hospitalized in an Health and Social Establishment for purposes other than participation in this study
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 24 and 52
    E.5.2Secondary end point(s)
    ESSDAI score; stimulated salivary flow; oral dryness numeric response scale; B cell quantification within the salivary gland
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 24 and 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    transcriptomic and proteonomic analyses
    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
    Sponsor unblinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA26
    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
    Canada
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 120
    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 will not receive any additional treatment from GSK after completion of the
    study.

    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject’s medical condition, whether or not GSK is providing specific post-study treatment.
    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 Decision2015-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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