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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
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    Summary
    EudraCT Number:2007-004892-21
    Sponsor's Protocol Code Number:IP-004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-12-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-004892-21
    A.3Full title of the trial
    Estudio Fase IIb, Multicéntrico, Aleatorizado, Doble-Ciego, Controlado con Placebo de Búsqueda de dosis, para Evaluar Eficacia, Seguridad y Tolerabilidad de Dos Dosis Subcutáneas de IPP-201101 Más Medicación de Base, Frente a Placebo Más Medicación de Base en Pacientes con Lupus Eritematoso Sistémico (LES)
    A.4.1Sponsor's protocol code numberIP-004
    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 SponsorIMMUPHARMA SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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.3.2Product code IPP-201101
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboPowder for injection*
    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
    Lupus Eritematoso Sistémico (LES)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of subcutaneous (sc) IPP201101 on the signs and symptoms of disease activity in subjects with active SLE, over a 12-week treatment period, compared to placebo
    E.2.2Secondary objectives of the trial
    • To investigate the effect of IPP-201101 on biological markers of disease activity
    • To investigate the effect of IPP201101 on the incidence of disease flares
    • To investigate the effect of IPP201101 on the occurrence of SLE-induced organ damage
    • To investigate the effect of IPP201101 on the health related quality of life (HRQoL)
    • To assess the durability of the therapeutic affects, over a 12-week follow up period
    • To identify the optimal dosing regimen of IPP201101, in order to determine the dosing regimen of Phase III clinical studies
    • To evaluate the safety and tolerability of sc IPP201101 in subjects with active SLE receiving standard therapy, compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women  18 and < 70 years of age.
    2. Women must be of non-childbearing potential,
    - or if of childbearing potential (as determined by the investigator) must be using an effective method of birth control for 30 days prior to first administration of study drug and must agree to continue such precautions for the duration of the study.
    3. Capable of understanding and complying with the protocol and be available for the duration of the study
    4. Signed written informed consent form prior to initiation of any study related procedures
    5. Established diagnosis of Systemic Lupus Erythematosus (SLE) defined by ACR Classification Revised Criteria (1997). The diagnosis is fulfilled provided that at least 4 criteria are met
    6. A SLEDAI-2K score of at least 6 points and no "A" score on the BILAG scale
    7. Positive test for antinuclear antibodies (ANA)
    8. If using oral corticosteroids:
    • The weekly cumulative dose must not exceed 80mg of prednisone equivalent or 72 mg budesonide;
    • the weekly dose must be stable over the 4 weeks preceding study start
    9. If using antimalarials, methotrexate, leflunomide, mycophenolate mofetil, or azathioprine:
    • the start-date must be at least 3 months prior to study start and
    • the daily dose must be stable over the 4 weeks preceding the study start
    10. If not currently using corticosteroids, antimalarials, methotrexate, mycophenolate mofetyl, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to study start. For leflunomide, the stop date must be at least 8 weeks before study start, unless an adequate cholestyramine wash-out has been completed
    11. If using angiotensin converting enzyme inhibitors or angiotensin receptor antagonists must be stable for at least 4 weeks prior to baseline assessment
    E.4Principal exclusion criteria
    1. Female subjects of childbearing potential unless using a reliable contraception method and women who are pregnant or lactating
    2. Treatment with dosage of prednisone equivalent > 80 mg /week (or > 72 mg of budesonide).
    3. Treatment with intravenous pulse steroids within 4 weeks of Baseline.
    4. Intravenous immunoglobulins (IgG), tacrolimus, or cyclosporine A within 3 months of Baseline.
    5. Cyclophosphamide is not allowed within 12 months prior to study start and throughout the study
    6. Treatment with biologic agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 12 months of study start.
    7. Subjects having received B-cell depleting agents such as rituximab who have not yet normalized their B-cell count
    8 Planned immunization with a live vaccine within 3 months prior to study treatment start and 3 months after treatment cessation
    9. Previous or current history of malignancy (except subjects with a remote history (e.g greater than 5 years previously) of basal cell carcinoma, cervical carcinoma in situ).
    10. Clinically significant abnormalities on chest X-Ray or electrocardiogram that are not related to SLE, as defined by the Principal Investigator
    11. Any concomitant medical condition unrelated to SLE, which in the opinion of the Principal Investigator, may interfere with the safety or the evaluation of the study, including:
    • Chronic heart failure, previous myocardial infarction, chest pain within the last 3 months with changes in ECG and/or increased cardiac enzymes,
    • Ongoing active infection requiring antibiotic therapy,
    • Severe infection, such as hepatitis or pneumonia in the past three months. Ongoing active infection requiring antibiotic therapy, Less severe infections in the past 3 months are permitted at the discretion of the Principal Investigator
    • Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive
    • Chronic liver failure,
    • Uncontrolled diabetes mellitus,
    12. Current drug and alcohol abuse as evidenced by medical history at Screening
    13. Psychiatric, addictive, or any other disorder that compromises the ability to give truly informed written consent for participation in this study
    14. Subjects with a history of severe allergic reactions to or hypersensitivity to any component of the drug or placebo
    15. Has undergone or is undergoing treatment with another investigational drug within 6 months prior to entry in this study
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving a combined clinical response at week 12. A combined clinical response is defined as: A reduction from baseline in the SLEDAI-2000 score of at least 4 points; no worsening in Physician’s Global Assessment (PGA) (with worsening defined as an increase in PGA of more than 0.30 points from baseline); no new British Isles Lupus Assessment Group (BILAG) A organ domain score and no more than 1 new BILAG B organ domain score from baseline.
    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 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) 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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 204
    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 Decision2008-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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