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    Summary
    EudraCT Number:2008-004894-16
    Sponsor's Protocol Code Number:H9B-MC-BCDH
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-11-26
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-004894-16
    A.3Full title of the trial
    Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
    A.4.1Sponsor's protocol code numberH9B-MC-BCDH
    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 SponsorEli Lilly and Company limited
    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 nameLY2127399
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY2127399
    D.3.9.3Other descriptive nameAnti LP40 antibody, subclass IgG4 LA294
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48
    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 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 placeboInjection*
    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
    Rheumatoid arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the hypothesis that the ACR50 response after 24 weeks for the smallest dose that achieves at least 95% of the maximal efficacy (ED95) of LY2127399 is significantly greater than for placebo, when study drug is administered subcutaneously once monthly in patients with active RA despite ongoing MTX therapy.
    E.2.2Secondary objectives of the trial
    • estimate maximum response to LY2127399, ED95, and smallest dose achieving maximum response of ACR20 and ACR50 at 24 weeks
    • determine whether there is a minimally effective dose (smallest dose with at least 25% absolute efficacy difference from placebo in ACR50 and ACR20) and to estimate that dose
    • evaluate LY2127399 dose-ACR50 response and dose-ACR20 response relationships at 24 weeks relative to placebo
    • characterize relationships between LY2127399 dose, exposure, and response of selected PD endpoints
    • evaluate LY2127399 safety and tolerability compared to placebo
    • evaluate PD of selected peripheral B cell subsets compared to placebo
    • explore potential associations between selected biomarkers and selected disease activity measures
    • further characterize LY2127399 PK in RA patients on MTX therapy
    • evaluate potential effect of LY2127399 compared to placebo on additional patient-reported outcomes as measured by the:
    ο FACIT Fatigue Scale
    ο Medical Outcomes SF-36
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Ambulatory males or females between the ages of 18 and 75 years, inclusive.
    [2] Women must not be pregnant or breastfeeding during study participation. Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must have a negative pregnancy test and must use an acceptable form of contraception during the study. Methods of contraception considered acceptable are oral contraceptives, contraceptive patch, intrauterine device (IUD), vaginal ring, diaphragm, or condom with contraceptive gel.
    [3] Diagnosis of RA according to the ARA 1987 Revised Criteria for the Classification of RA (Arnett et al. 1988).
    [4] Regular use of MTX for at least 16 weeks, and at a stable dose between 10 and 25 mg/wk, inclusive, for at least 8 weeks prior to baseline. Local standard of care should be followed for concomitant administration of folic acid.
    [5] History of, or current, positive rheumatoid factor (RF) test.
    [6] ACR functional class I, II, or III (Protocol Attachment BCDH.2).
    [7] Have active RA defined as at least 5 swollen and at least 5 tender joints based on the 28 joint count specified (Section 6.1.2.2 [Tender Joint Counts] and Section 6.1.2.3 [Swollen Joint Counts]).
    [8] Have a screening CRP of at least 1.2 times upper limit of normal (ULN).
    [9] Clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations as judged by the investigator.
    [10] Venous access sufficient to allow blood sampling as per the protocol.
    [11] Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
    [12] Are able to read, understand, and give written informed consent approved by Lilly or its designee and the ethical review board (ERB) governing the site.
    E.4Principal exclusion criteria
    [1] Have received any parenteral corticosteroid administered by intraarticular, intramuscular, or IV injection within 4 weeks of baseline.
    [2] Within 4 weeks prior to baseline, either use of oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent, or use of variable doses of oral corticosteroids.
    [3] Have received any B cell biotherapies at anytime in the past, whether the indication for therapy was RA or not.
    [4] Have been treated for at least 3 months at approved doses with at least 1 biologic TNFα inhibitor therapy and have had an inadequate efficacy response to such treatment in the opinion of the investigator. Patients must have stopped etanercept ≥28 days, and infliximab, adalimumab, or other biologic TNFα inhibitor therapy ≥56 days prior to baseline.
    [5] Have had an inadequate response to treatment with 3 or more of the following DMARDs prescribed alone or in combination at approved doses for a minimum of 3 months: abatacept, leflunomide, azathioprine, cyclosporine, and sulfasalazine.
    [6] Use of other DMARDs other than MTX, hydroxychloroquine, or sulfasalazine, in the 8 weeks prior to baseline. If on hydroxychloroquine or sulfasalazine, must be on the drug for 16 weeks and at a stable dose for at least 8 weeks prior to baseline.
    [7] Use of leflunomide in the 12 weeks prior to baseline. Cholestyramine may be used to shorten the washout period for leflunomide, according to standard protocol
    [8] Use of NSAIDs for <2 weeks prior to baseline.
    [9] Diagnosis of any systemic inflammatory condition other than RA.
    [10] Evidence of active vasculitis.
    [11] Diagnosis of Felty’s syndrome.
    [12] Surgical treatment of a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study.
    [13] Have previously completed or withdrawn from this study or any other study investigating LY2127399.
    [14] Abnormality in the 12-lead ECG that in the opinion of the investigator increases the risk of participating in the study or a Bazett’s corrected QT interval >450 msec for men and >470 msec for women.
    [15] Uncontrolled arterial hypertension characterized (sBP >160 mmHg or dBP >100 mmHg.
    [16] Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease.
    [17] History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders constituting a risk when taking the study medication or of interfering with the interpretation of data. Subjects on a stable dose of thyroid replacement therapy during the 6 months preceding baseline who are clinically or biochemically euthyroid may enroll in the trial.
    [18] Evidence of significant active neuropsychiatric disease, in the opinion of the investigator.
    [19] Serious bacterial infection within 6 months of enrollment.
    [20] Symptomatic herpes zoster within 3 months of enrollment.
    [21] Evidence of HIV and/or positive human HIV antibodies.
    [22] Evidence of hepatitis C and/or positive hepatitis C antibody.
    [23] Evidence of hepatitis B and/or positive hepatitis B surface antigen.
    [24] Evidence or suspicion of active TB by medical history, physical examination and/or screening chest radiograph.
    [25] At the time of screening, a positive purified protein derivative (PPD) test for TB. For the purpose of this study, a positive test is defined as induration ≥10 mm, between approximately 2 and 3 days after test application. Exceptions to this criterion include patients with a history of a positive PPD who have been treated with isoniazid (INH) (documented) for at least 6 months, or patients with a previous diagnosis of TB who have received appropriate treatment (documented) and have not been re-exposed to TB since their treatment was completed.
    [26] Other recent or ongoing infection that in the opinion of the investigator poses an unacceptable risk to participate in the study.
    [27] Exposed to a live vaccine within 3 months of enrollment or expected to need/receive a live vaccine during the course of the study.
    [28] Significant hematological abnormalities, including hemoglobin <8.0 g/dL, total platelet count <100,000/μL, total white blood cell (WBC) count <3000/μL, neutrophil count <1000/μL, or lymphocyte count <200 cells/μL.
    [29] Screening serum creatinine >2.0 mg/dL.
    [30] Known hypogammaglobulinemia or a serum IgG, IgM, or IgA concentration less than lower limit of normal.
    [31] Any history of chronic liver disease or with serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >1.2x the ULN. The AST and ALT may be repeated once within a week.
    [32] Blood donation of more than 500 mL within the last month.
    [33] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    E.5 End points
    E.5.1Primary end point(s)
    ACR50 responder index (based on the 28 joint count) at 24 weeks after 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    N/A
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 150
    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)
    N/A; standard treatment
    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 Decision2009-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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