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    Summary
    EudraCT Number:2007-002566-35
    Sponsor's Protocol Code Number:SL0007
    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:2007-11-29
    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 number2007-002566-35
    A.3Full title of the trial
    A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease.
    A.3.2Name or abbreviated title of the trial where available
    SL0007
    A.4.1Sponsor's protocol code numberSL0007
    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 codeCDP3194
    D.3.9.3Other descriptive namehLL2
    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
    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
    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
    assess the dose response and the dose frequency of epratuzumab during one 12-week treatment cycle in moderate to severe systemic lupus patients with active disease.
    E.2.2Secondary objectives of the trial
    - assess the safety of epratuzumab
    - optimize knowledge about efficacy assessments to be carried to phase III confirmatory trials
    - assess the kinetics and attributes of B and T cells in circulation
    - assess the pharmacokinetics and pharmacodynamics of epratuzumab over a dose range including exposure response modeling and immunogenicity assessments
    - explore candidate biomarkers and gene expression relative to risk, prognosis, and response to epratuzumab treatment
    - assess the health-related quality of life benefits of epratuzumab treatment
    - explore the utility benefits of epratuzumab treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Gene Expression Profiling (described in section 11 of the SL0007 protocol)
    objectives:
    - Identification of early stratification markers for drug response (efficacy, safety)
    - Identification of markers for disease activity
    - Identification of markers for efficacy
    - Identification of markers for safety
    - Understanding the molecular mechanism of action of Epratuzumab
    E.3Principal inclusion criteria
    1. Male or female patients aged equal to or greater than 18 years of age at Visit 1 (screening).
    2. Signed written informed consent prior to the initiation of any study-specific assessment at Visit 1 (screening).
    3. Adequate reading and writing abilities (in their native language) such that the patient can comprehend and answer the questions on the patient completed assessments.
    4. Positive ANA result at Visit 1 (screening) either via screening or confirmatory central laboratory testing methodologies.
    5. Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 (not including Neurologic Disorder) of the 11 criteria are met. If positive for Neurologic Disorder criteria, a total of 5 of the 11 ACR criteria must be met.
    6. Active moderate or severe SLE disease activity as demonstrated by BILAG A level disease activity in at least one body/organ system (except renal or neurological) or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present. At least one of the BILAG A scores OR at least two of the BILAG B scores must be in the following categories: Mucocutaneous, Musculoskeletal or Cardiovascular/ Respiratory.
    7. Active moderate or severe SLE disease activity as demonstrated by SLEDAI total score of at least 6 at Visit 1 (screening).
    8. If on antimalarials, must have been receiving antimalarials for at least 12 weeks, with a stable dose regimen for at least 28 days (-1 day) prior to Visit 2 and first study medication infusion and must be maintained at the same stable dose for the entire study.
    9. If on immunosuppressives, must be on a stable dose for 28 days (-1 day) prior to Visit 2 and first study medication infusion and must be maintained at the same stable dose for the entire study. Maximum allowed doses for commonly prescribed immunosuppressives are listed in Table 10:1 of the protocol. Immunosuppressant must not include any immunosuppressants specifically mentioned in the exclusion medication table.
    10. Receiving corticosteroids within the range of 5 to 60 mg/day prednisone (or equivalent) at a stable dose for at least five days (-1 day) prior to Visit 2 and the first study drug infusion, with the corticosteroid dose dependent on the investigator’s assessment of disease severity. If steroids are initiated or increased for current disease flare, this increase must not have occurred more than 14 days (-1 day) prior to Visit 2 and the first infusion of study medication. Use of IV (including high pulse doses of IV Solu-Medrol), IM or IA injections of corticosteroids are not allowed at any time during the trial.
    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 or serum creatinine >2.5mg/dL or clinically significant (per investigator judgment) serum creatinine increase within the 28 days (-1 day) 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 serum pregnancy test taken at Visit 1 which is confirmed to be negative prior to the first dose of study medication at Visit 2. Additionally, a urine pregnancy test will be completed prior to all remaining doses and must be negative in order for the subject to receive the study drug. Urine pregnancy tests will then be repeated every 4 weeks and at the Follow up Visit. Women of childbearing potential must use an acceptable method of birth control during the trial and for a period of 3 months after the last dose of study medication. Acceptable forms of birth control include oral contraceptives [which must be stable for at least one full month prior to Visit 1and should remain stable during the study], double barrier methods and the single-barrier methods of diaphragm with adjunct spermacide or condom with adjunct spermacide. Unacceptable methods include abstinence alone or condoms/diaphragm use without adjunct spermacide. Women not receiving birth control must be surgically sterile (hysterectomy/oophrectomy or tubal ligation) or postmenopausal for at least 2 years prior to (Visit 1) screening.
    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 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 (screening) 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 principal investigator are at a particularly high risk of significant 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 fully participate in the study.
    8. Patients receiving any vaccination (including live attenuated, toxoid and subunit) within 14 days prior toVisit 1 (screening) or during the course of the study. Influenza and human papillomavirus vaccines are allowed prior to study entry but are prohibited during the study. Tetanus vaccines are allowed prior to study entry and during the study.
    9. Spontaneous or induced abortion, still or live birth within 4 weeks prior to Visit 1.
    10. Use of oral anticoagulants or anti-platelet treatment regardless of route or indication (not including NSAIDS) within the 28 days (-1 day) prior to Visit 1 or at any time during the study.
    11. Patients with a history of anti-phospholipid antibody syndrome.
    12. 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.
    13. History of malignant cancer, except the following treated cancers: cervical CIS, basal cell carcinoma or squamous cell carcinoma provided that the cancer is not current and treatment has been completed.
    14. History of treatment with investigational human or chimeric antibodies within 3 months. History of treatment with belimumab (Lymphostat B), or CTLA4-Ig within 6 months, or with rituximab or other anti-B-cell antibodies within 12 months. The use of investigational agents, not specified above, including other investigational biologic or device products, within 28 days prior to Visit 1 (screening) or during the study. Use of the following medications in Table 9:1 of the protocol regardless of route, are prohibited within the time frame (wash-out period) as listed in the table prior to Visit 2 and the first infusion of study medication, or at any time during the study.
    E.5 End points
    E.5.1Primary end point(s)
    responder rate at week 12 according to a combined response index.
    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 No
    E.6.11Pharmacogenomic Yes
    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 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.8.5The 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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 210
    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 completing the trial or discontinuing early due to lack of efficacy may be eligible to enter an open label extension trial with duration to last until approval or withdrawal of application for approval. Patients not entering extension 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 Decision2008-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-17
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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