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    Summary
    EudraCT Number:2009-009696-34
    Sponsor's Protocol Code Number:I1F-MC-RHAK(b)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-14
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-009696-34
    A.3Full title of the trial
    A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Patients with Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberI1F-MC-RHAK(b)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00966875
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressN.A.
    B.5.3.2Town/ cityN.A.
    B.5.3.3Post codeN.A.
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@Lilly.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 nameLY2439821
    D.3.2Product code LY2439821
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN.A.
    D.3.9.2Current sponsor codeLY2439821
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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
    bDMARD naive population ONLY
    To determine the dose-response relationship of LY2439821 at week 12, as measured by the proportion of American College of Rheumatology 20 (ACR20) responders.
    E.2.2Secondary objectives of the trial
    TNFα-IR population ONLY
    • To evaluate the efficacy of LY2439821 at Week 12 compared to placebo as measured by the proportion of ACR20 responders.
    bDMARD-naive population ONLY
    • To estimate the smallest doses that achieve 10%, 50%, and 90% of the maximum ACR20 response (ED10, 50, and 90, respectively) at Week 12.
    • To evaluate the dose-response relationship of LY2439821 at Week 12 and the doses that achieve 10%, 50%, and 90% of the maximum response (ED10, 50, and 90, respectively) at Week 12 as measured by the Disease Activity Score [DAS] based on the 28 diarthroidal joint count (DAS28) and the ACR50 response rates.
    BOTH bDMARD-naive AND TNFα-IR populations, separately

    • see.....Protocol page 32-33
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Sample Banking Addendum l1F-MC-RHAK(1)
    A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy
    Version date 17 Nov 2008
    E.3Principal inclusion criteria
    Inclusion Criteria Common to Both Populations
    [1] Ambulatory males or females, 18 years to 75 years, inclusive.
    [1a] Male patients:
    Agree to use a reliable method of birth control during the study.
    [1b] Female patients:
    Are women of childbearing potential who test negative for
    pregnancy and agree to use a reliable method of birth control
    during the study. Methods of contraception considered
    acceptable are oral contraceptives, contraceptive patch,
    intrauterine device, vaginal ring, diaphragm, or condom with
    contraceptive gel.
    OR
    Are women who have undergone surgical sterilization
    (hysterectomy, bilateral oophorectomy, or tubal ligation).
    OR
    Are post menopausal female patients defined as women
    >45 years of age who have had a cessation of menses for at least
    12 months OR are women between 40 and 45 years of age who
    test negative for pregnancy, have had a cessation of menses for at
    least 12 months, and have a Follicle Stimulating Hormone (FSH)
    value >40 mIU/mL.
    [2] RA diagnosis by American Rheumatism Association 1987 Revised Criteria.
    [4] At least 6 tender and at least 6 swollen joints.
    [5] C-reactive protein (CRP) >ULN or erythrocyte sedimentation rate (ESR) of at least 28 mm/hr.
    Inclusion Criterion Specific to the bDMARD-naive Population
    [6] Regular use of MTX for at least 12 weeks, and stable treatment (7.5 mg/week to 25 mg/week) for at least 8 weeks prior to baseline.
    Inclusion Criterion Specific to the TNFa-IR Population
    [7] TNFa-IR patients must have been treated at approved doses with at least 1 biologic TNFα inhibitor therapy and in the opinion of the investigator EITHER: a) had an insufficient response to at least 3 months of treatment (stopped due to insufficient efficacy), OR b) have been intolerant of such treatment, regardless of treatment duration.
    [8] Regular use of at least 1 conventional DMARD in a stable treatment regimen as specified.
    Some of the included criteria have been condensed from protocol language. Refer to protocol pages 39-40 for the full list and full text of all Inclusion/Exclusion Criteria.
    E.4Principal exclusion criteria
    Exclusion Criteria Specific to the bDMARD naive Population
    [9] Have received any prior biologic DMARD therapy.
    [10] Have had, in the opinion of the investigator, an inadequate response to
    treatment with 5 or more conventional DMARDs (such as
    leflunomide, azathioprine, cyclosporine, hydroxychloroquine, gold
    salts, and sulfasalazine), prescribed alone or in combination, at
    approved doses, for a minimum of 3 months.
    [11] Use of DMARDs other than MTX, hydroxychloroquine, or
    sulfasalazine (for example, gold salts, cyclosporine, azathioprine, or
    any other immunosuppressives) in the 8 weeks prior to baseline.
    [12] Use of leflunomide in the 12 weeks prior to baseline. Cholestyramine may be used to shorten the washout period from 12 to 4 weeks for leflunomide, if used according to standard protocol (Van Riel et al. 2004).
    Exclusion Criteria Specific to the TNFa-IR Population
    [13] Concurrent or recent use of any biologic DMARDs or biologic TNFα inhibitor therapies within specified washout periods.
    Exclusion Criteria Common to Both Populations
    [15] Concomitant use of NSAIDs in Part A, unless patient is on stable dose for at least 2 weeks prior to baseline.
    [16] Parenteral glucocorticoid administered by intra-articular, intramuscular, or IV injection within 4 weeks of baseline, or for whom a parenteral injection of glucocorticosteroids is anticipated during the course of the study.
    [17] 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 within 4 weeks prior to baseline.
    [18] Live vaccination within 12 weeks before baseline, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within 12 weeks prior to baseline.
    [19] Have a diagnosis of any systemic inflammatory condition other than RA, such as juvenile RA, seronegative spondyloarthropathy, Crohn’s disease, ulcerative colitis, psoriasis, or psoriatic arthritis.
    [23] Have had 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.
    [24] Have findings, or a history of, clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, which in the opinion of the investigator, place the patient at an unacceptable risk for participation in the study or of interfering with the interpretation of data.
    [26] Serious bacterial infection within 3 months of entry, or a recent or ongoing infection that in the opinion of the investigator poses an unacceptable risk to participate in the study.
    [27] Evidence or suspicion of active tuberculosis (TB) by medical history, physical examination, and/or chest radiograph or documentation of TB by a positive purified protein derivative (PPD) test.
    Exceptions to this criterion include patients with latent TB, who have a documented treatment history with isoniazid (INH) for at least 6 months or a rifampicin-based regimen for at least 3 months; or patients who have received documented, completed, effective chemotherapy for active TB with no history of re-exposure since their treatment was completed; or patients with a history of BCG vaccination within the 10 years prior to baseline and who have a negative chest x-ray.
    [28] Uncontrolled arterial hypertension characterized by a systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.
    [29] Are positive for human immunodeficiency virus (HIV; positive for human immunodeficiency virus antibody [HIVAb]).
    [30] Have hepatitis C virus (HCV; positive for anti-hepatitis C antibody).
    [31] Have evidence of active hepatitis B virus (HBV; positive for hepatitis B surface antigen [HBsAg]).
    [32] Clinical laboratory test results outside the normal reference range or with unacceptable deviations considered clinically significant by the investigator, and/or have any of the following specific abnormalities:
    • Neutropenia (polymorphonuclear leukocytes <1500 cells/mL).
    • Thrombocytopenia (platelets <100,000 cells/mL).
    • AST or ALT >2X ULN (retest allowed 1x).
    • Total WBC < 3000 cells/mL
    • Hemoglobin <8.5 g/dL (85.0 g/L) for m and <8.0 g/dL (80.0 g/L) for f
    [33] Have a serum creatinine >2.0 mg/dL.
    [34] Hypogammaglobulinemia or a serum IgG, IgM, or IgA concentration less than the lower limit of normal.
    [35] Have an abnormality in the 12-lead ECG that, increases the risk of participating in the study, including patients with ECG finding of a Bazett’s corrected QT interval >450 ms for men and >470 ms for women
    [42] Women who are lactating or breast feeding
    Some of the included criteria have been condensed from protocol language. Refer to protocol pages 41-45 for the full list and full text of all Inclusion/Exclusion Criteria.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the dose-response relationship of LY2439821 at week 12, as measured by the proportion of ACR20 responders. Biologic disease modifiying anti-rheumatic drug-naive population (bDMARD-naive) only
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    Proportion of American College of Rheumatology (ACR) 20 responders; Tumor Necrosis Factor alpha-inadequate responder population (TNF-a-IR) only
    Smallest doses that achieve 10%, 50%, and 90% of the maximum American College of Rheumatology (ACR) 20 response; Biologic disease modifying anti-rheumatic drug-naive population (bDMARD-naive) only
    Smallest doses that achieve 10%; 50% and 90% of maximum Disease Activity Score (DAS) 28 response; Biologic disease modifying anti-rheumatic drug-naive population (bDMARD-naive) only
    Smallest doses that achieve 10%; 50% and 90% of maximum American College of Rheumatology (ACR) 50 response; biologic modifying anti-rheumatic drug naive population (bDMARD-naive) only
    Change from baseline in Desease Activity Score (DAS28)
    Proportion of American College of Rheumatology (ACR)20/50/70 responders
    Change from baseline in individual components of the American College of Rheumatology (ACR) core set Proportion of patients in European League Against RheumatismRheumatism Responder Index (EULAR28)
    Actual value of American College of Rheumatology (ACR)-N
    Change from baseline in duration of morning stiffness (minutes)
    Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
    Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
    Relationship between exposure and response of individual components of the American College of Rheumatology (ACR) core set
    Relationship between exposure and response of American College of Rheumatology (ACR) 20/50/70N
    Relationship between exposure and response of Disease Actitivy Score (DAS)28
    Relationship between exposure and response of European League Against Rhematism (EULAR)28
    E.5.2.1Timepoint(s) of evaluation of this end point
    First 4 bullets at Week 12
    Rest of secondary endopoints at Week 72
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Argentina
    Chile
    Germany
    India
    Korea, Republic of
    Peru
    Poland
    Romania
    Russian Federation
    Taiwan
    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 date of the last visit or last scheduled procedure at the last site as shown in the Study Schedule for the last active patient in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 648
    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)
    Alternative treatments are commercially available for the management of RA. Therefore, no additional doses of LY2439821 will be provided to patients after their participation in Part B of this study.
    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 Decision2009-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
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