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    Summary
    EudraCT Number:2010-020859-30
    Sponsor's Protocol Code Number:SL0012
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-10
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-020859-30
    A.3Full title of the trial
    A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4)
    Egy fázis 3, több vizsgálati központban zajló, nyílt, kiterjesztett vizsgálat az Epratuzumab kezelés biztonságosságának és tolerálhatóságának meghatározására szisztémás lupusz eritematózuszban szenvedő betegekben (EMBODY 4)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
    Nyílt klinikai vizsgálat a hosszútávú Epratuzumab kezelés vizsgálatára szisztémás lupusz eritematózuszban szenvedő betegeknél (SLE)
    A.3.2Name or abbreviated title of the trial where available
    EMBODY 4
    A.4.1Sponsor's protocol code numberSL0012
    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 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 supportUCB Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+49.2173.48.1515
    B.5.5Fax number+49.2173.48.1572
    B.5.6E-mailclinicaltrials@ucb.com
    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 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 INNEpratuzumab
    D.3.9.1CAS number 205923-57-5
    D.3.9.2Current sponsor codeCDP3194
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 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
    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 Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    The primary objective of the study is to assess the safety and tolerability of long-term epratuzumab treatment in subjects with SLE.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the efficacy and immunogenicity of long-term epratuzumab treatment in subjects with SLE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The subject has completed double-blind study SL0009 or SL0010, or
    the subject has terminated prematurely at Week 16 or later in SL0009 or
    SL0010 due to lack of efficacy, as described in the respective protocols
    and would, in the opinion of the investigator,
    continue to benefit from continued epratuzumab treatment in SL0012.
    The subject has completed open-label study SL0006 or SL0008, and
    would, in the opinion of the investigator, continue to benefit from
    continued epratuzumab treatment in SL0012.
    - Woman of childbearing potential using an acceptable method of birth
    control.
    - Male subjects must agree to ensure they or their female partner(s) use
    adequate contraception during the study and for a period of 3 months
    after their final dose of study drug.epratuzumab treatment in SL0012. The subject has completed open-label study SL0006 or SL0008, and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012.
    - The subject has maintained the eligibility requirements (including concomitant medication restrictions) throughout their participation in the prior study.
    - Woman of childbearing potential using an acceptable method of birth control.
    - Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for a period of 3 months after their final dose of study drug.
    E.4Principal exclusion criteria
    - Subject has active, severe, neuropsychiatric SLE, defined as any
    neuropsychiatric element scoring BILAG level A disease.
    - Subject has active, severe, SLE disease activity which involves the
    renal system defined by BILAG renal level A activity.
    - Evidence of an immunosuppressive state.
    - Subjects with a history of chronic infections, including but not limited
    to subjects with concurrent acute or chronic viral hepatitis B or C.
    - Subjects with substance abuse/dependence or other concurrent
    medical conditions.
    -History of malignant cancer.
    - Subjects receiving any biological therapy after ending their participation in SL0006, SL0008, SL0009 or SL0010.
    - Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study. Subjects with significant hematologic abnormalities, such as hemoglobin <8.0 g/dL, or WBC <2000/mm3, or absolute neutrophil count <1500/mm3, or platelets <30,000/mm3, at the last visit of SL0006, SL0008, SL0009, or SL0010 may be included in the study only after discussion with and approval of the medical monitor (the laboratory results from SL0009 and SL0010 should not be older than 28 days).
    E.5 End points
    E.5.1Primary end point(s)
    The percent of subjects meeting treatment response criteria at Week 96 and Week 192 according to a combined response index.
    E.5.1.1Timepoint(s) of evaluation of this end point
    96 and 192 weeks
    E.5.2Secondary end point(s)
    The percent of subjects meeting treatment response criteria at time points other than Week 96 and Week 192, according to the combined index.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline - 192 weeks
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA88
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Mexico
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Taiwan
    Ukraine
    United States
    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
    The end of study is defined as the date of the last visit of the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months1
    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: 1215
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1250
    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)
    Subject will return to their normal standard of care therapy as
    determined by their physician.
    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 Decision2011-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-16
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