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    Summary
    EudraCT Number:2007-002589-37
    Sponsor's Protocol Code Number:SL0008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-04
    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 number2007-002589-37
    A.3Full title of the trial
    A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007.
    A.3.2Name or abbreviated title of the trial where available
    SL0008
    A.4.1Sponsor's protocol code numberSL0008
    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 SponsorUCB 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 nameepratuzumab
    D.3.2Product code CDP3194
    D.3.4Pharmaceutical form Solution for infusion
    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 INNepratuzumab
    D.3.9.1CAS number 205923-57-5
    D.3.9.2Current sponsor codehLL2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    systemic lupus erythematosus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    continue to assess the safety of epratuzumab dosed at 1200mg bi-weekly for a total of two doses in 12-week re-treatment cycles in moderate to severe systemic lupus patients.
    E.2.2Secondary objectives of the trial
    - continue to assess the tolerability of epratuzumab.
    - continue to assess the efficacy of epratuzumab.
    - continue to assess the kinetics and attributes of B and T cells in circulation.
    - continue to assess the pharmacokinetics, pharmacodynamics and immunogenicity of epratuzumab.
    - continue to assess the health-related quality of life benefits of epratuzumab treatment.
    - continue to assess the utility benefits of epratuzumab treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. SL0007 patients completing week 12 and patients early terminating at study week 8 (Visit 8) or later due to treatment failure as described in the SL0007 protocol.
    2. Patients who completed study SL0007 must have maintained eligibility requirements (including concomitant medication restrictions) throughout their participation in the SL0007 study. Patients who terminated study SL0007 early due to use of restricted concomitant Lupus medications (e.g. increased corticosteroid dose) resulting in treatment failure may be eligible to enter SL0008. These patients should be discussed with the medical monitor on a case by case basis.
    3. Written informed consent signed prior to the initiation of any study-specific assessments at Visit 1 (patients who will be participating in SL0008 must sign informed consent for study SL0008 prior to receiving any assessments for the last visit of SL0007 as data from this visit will be used for both studies).
    E.4Principal exclusion criteria
    1. Active, severe neuropsychiatric SLE including but not limited to BILAG A criteria as follows: existing aseptic meningitis, cerebral vasculitis, demyelination syndromes (including ascending or transverse myelitis and acute inflammatory demyelinating polyradiculoneuropathy), myelopathy, acute confusional state, impaired level of consciousness, psychosis, cranial neuropathy, plexopathy, grand mal seizure, status epilepticus, cerebellar ataxia, stroke or stroke syndrome, chorea or any other severe neurologic condition which, in the opinion of the investigator, would prevent the subject from completing protocol required procedures. Mononeuritis multiplex is NOT excluded provided it is not new (within the past 4 weeks).
    2. Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine
    > 2.5mg/dL or clinically significant (per investigator judgment) serum creatinine increasde within the 4 weeks prior to Visit 1 or proteinuria > 3.5gm/day.
    3. Female subjects who are pregnant or lactating. Women of childbearing potential are required to have a negative pregnancy test at Visit 1 prior to the first dose of study medication. A urine pregnancy test will be completed every 4 weeks for the duration of the trial and must be negative in order for the subject to continue in the trial. Women of childbearing potential must use an acceptable method of birth control during the study and for a period of 3 months after the last dose of study medication (oral contraceptives must be stable for at least one full month prior to Visit 1). Abstinence alone or condoms/diaphragm use without adjunct spermacide are not an acceptable method of contraception for the study. Use of barrier contraception is acceptable, including double barrier methods and the single-barrier methods of diaphragm with adjunct spermacide or condom with adjunct spermacide. Females not receiving birth control must be surgically sterile, postmenopausal for at least 2 years prior to Visit 1, or must have undergone tubal ligation.
    4. Evidence of an immunosuppressive state including HIV infection, agammaglobulinemias, T-cell deficiencies or HTLV-1 infection at any time prior to or during the study.
    5. Patients with a history of chronic infections including, but not limited to hepatitis B or C. Patients with a history of a recent, serious or life-threatening infection (e.g. pneumonia or herpes zoster) or any current sign or symptoms that may indicate a significant infection at Visit 1 as per the Investigator’s clinical judgment. Patients must have completed any antibiotics prior to the first dose of study medication.
    6. Patients who in the opinion of the investigator are at a particularly increased risk of developing a serious infection due to their lifestyle, occupational or social contacts.
    7. Substance abuse/dependence or other concurrent medical conditions that could confound study interpretation or affect the patient’s ability to tolerate or complete the study.
    8. Patients may not receive any live (or live attenuated) vaccines during the course of the study.
    9. Use of oral anticoagulants or anti-platelet treatment regardless of indication or route (not including NSAIDS) within the 4 weeks prior to Visit 1.
    10. Patients with a history of anti-phospholipid antibody syndrome.
    11. Significant hematologic abnormalities not attributed to Lupus including iron-deficiency anemia, hemoglobin < 8.0 g/dL, WBC < 2000/mm³, absolute neutrophil count < 1500/mm³, platelets < 50,000/mm³.
    12. History of malignant cancer, except the following treated cancers: cervical CIS, basal cell carcinoma or squamous cell carcinoma.
    13. Use of the medications in Table 9:1 (page 39 of protocol), regardless of route, during the SL0007 study or while enrolled in SL0008. Use of exclusionary medication during the trial will result in the patient being discontinued from trial participation.
    Use of any IV, IA, or IM injections of corticosteroids exceeding 120 mg methylprednisolone or 60 mg triamcinolone (or equivalent per day) is excluded during the SL0008 study. Use of exclusionary medication during the trial will result in the patient being discontinued from trial participation.
    E.5 End points
    E.5.1Primary end point(s)
    Number and percent of patients with BILAG improvement defined as BILAG A’s at study baseline (SL0007 Visit 1) improved to B/C/D and BILAG B’s at study baseline (SL0007 Visit 1) improved to C/D and no BILAG Worsening in other BILAG organ systems such that there are no new BILAG A’s or two new BILAG B’s as compared to Visit 1 of SL0007.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 175
    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)
    Patients discontinuing the trial will be followed up per standard of care by treating physicians.
    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 Decision2008-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-28
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