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    The EU Clinical Trials Register currently displays   35236   clinical trials with a EudraCT protocol, of which   5759   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-000705-59
    Sponsor's Protocol Code Number:IMMU-103-03
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-10-12
    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 number2005-000705-59
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems.
    A.3.2Name or abbreviated title of the trial where available
    Phase III Study of Epratuzumab in Severe Acute SLE Flares
    A.4.1Sponsor's protocol code numberIMMU-103-03
    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 SponsorImmunomedics, 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 Information not present in EudraCT
    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 IMMU-103
    D.3.4Pharmaceutical form Concentrate for 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.3.9.1CAS number 205923-57-5
    D.3.9.2Current sponsor codeIMMU-103
    D.3.9.3Other descriptive namehLL2 (trivial name or chemical description)
    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) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 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.1.2Classification code 10042945
    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 study objective is to demonstrate that epratuzumab is effective in the treatment of acute lupus flare.
    E.2.2Secondary objectives of the trial
    -To evaluate the effectiveness of epratuzumab in treating severe disease activity (acute flare) and in maintaining disease control
    -To evaluate the ability of epratuzumab to reduce the use of corticosteroids and other lupus medications.
    -To demonstrate the safety of epratuzumab in patients with SLE.
    -To assess the effect of adding epratuzumab to standard care on the quality of life of patients with SLE.
    Supplemental endpoints:
    -Time-to-reflare (new/recurrent BILAG A or B) among patients with no BILAG index B (or A) scores in any body/organ system at 4 weeks as well as the proportion of patients with these reflares.
    -Proportion of patients able to maintain successfull steroid-tapering from week 24 to week 48.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    -Male or female, 18 years and older;
    -Signed written informed consent obtained prior to study entry;
    -Has SLE by American College of Rheumatology revised criteria (meets at least 4 criteria);
    -Has had SLE for at least 6 months prior to study entry;
    -Has at least one elevated lupus-associated autoantibody level at or any time prior to study entry;
    -Has new onset of BILAG index A level activity in at least one body/organ system outside the renal and neurologic systems which developed within 4 weeks of study entry;
    -If initiated corticosteroids >20 mg/day prednisone (or equivalent) for treatment of the current flare, within 14 days of anticipated first infusion of study drug;
    -If on immunosuppresives, receiving a stable regimen for at least 8 weeks prior to study entry; and
    -If on antimalarials, receiving a stable regimenfor at least 12 weeks prior to study entry.
    E.4Principal exclusion criteria
    -Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test;
    -Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control during and for a period of 6 months after the completion of the study;
    -Active severe CNS disease;
    -Active severe renal disease;
    -Treatment with Lymphostat B, or CTLA4-Ig within 6 months, or with rituximab or other anti-B-cell ABs within 12 months;
    -Allergy to murine or human ABs;
    -Experimental therapy or any therapy with human or murine ABs within 3 months;
    Cyclophosphamide, cyclosporin, intravenous, joint or IM injections of corticosteroids exceeding 120 mg methylprednisolone, 60 mg triamcinolone, or equivalent; IV immunoglobulins, or any IMPs within 4 weeks;
    -Thrombosis, spontaneous or induced abortion, stillbirth or live birth, within 4 weeks;
    -Patients with antiphospholipid ABs AND a history of thromboembolic events;
    -On oral anticoagulants within 4 weeks;
    -History of malignancy (except basal or squamous cell carcinoma, cervical CIS);
    -Active infection receiving antibiotics within 7 days of screening or infection requiring hospitalization or herpes zoster treatment within 4 weeks; long-term infectious diseases (tuberculosis, fungal infections) active within 2 years;
    -Known HIV, hepatitis B or C infection, or other immunosuppressive states;
    -Live vaccine within 4 weeks;
    -Hematological abnormalities not attributed to lupus;
    -Liver transaminases or alkaline phosphatase > 3X upper limit of normal and not attributed to SLE;
    -Serum creatinine > 2.5 mg/dL or clinically significant increases within 4 weeks, or proteinuria > 3.5 mg/day; and
    -Substance abuse or other concurrent medical conditions that, in the investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint evaluated at 24 weeks is a patient response variable with three ordered categories; complete response (CR), partial response (PR) and non-response (NR).
    In order to be given a response status of CR or PR, a patient must meet two minimum conditionas: (i) not be considered a treatment failure and (ii) not have any BILAG Index A score in any body/organ system at any post-treatment evaluation time-point from weeks 4 to 24. In addition, if the patient also satisfies the protocol-defined steroid-tapering criterion at 24 weeks and does not have any BILAG Index B score, in any body/organ system at any post-treatment evaluation time-point from weeks 4 to 24, the patient will be assigned a CR status. Otherwise, the patient will be assigned a PR status provided the two minimum conditions are satisfied. Requirements for CR and PR are summarized in the protocol (page 22).
    A patient who fails to meet the two minimum conditions will be assigned a NR status.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Last patient, last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-10-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.6.1Details of subjects incapable of giving consent
    Women of childbearing potential who are not practicing or who are unwilling to practice birth control during and for a period of 6 months after the completion of the study are excluded from the study.
    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 255
    F.4.2.2In the whole clinical trial 510
    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)
    All patients will be given the option of being entered into an open-label extension protocol to receive epratuzumab for at least an additional 48 weeks using a maintenance cycle schedule.
    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 Decision2006-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-02
    P. End of Trial
    P.End of Trial StatusOngoing
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