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    Summary
    EudraCT Number:2010-022099-29
    Sponsor's Protocol Code Number:H9B-MC-BCDS
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-02-24
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2010-022099-29
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).
    A.3.2Name or abbreviated title of the trial where available
    ILLUMINATE-1
    A.4.1Sponsor's protocol code numberH9B-MC-BCDS
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01196091
    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.5.6E-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 nameLY2127399
    D.3.2Product code LY2127399
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeLY2127399
    D.3.9.3Other descriptive nameLA294; Anti LP40 antibody, subclass IgG4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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
    Systemic Lupus Erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus (SLE)
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.2System Organ Class 100000004859
    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 this study is to evaluate the efficacy of LY2127399 120 mg Q4W + SoC or 120 mg Q2W + SoC compared to placebo + SoC as assessed by the proportion of patients who achieve a response as defined by the SRI-5 at Week 52 in patients with SLE.

    Response is defined as follows:
    - Reduction of ≥5 points from baseline in SELENA-SLEDAI score;
    - No new BILAG A or no more than 1 new BILAG B disease activity scores;
    and
    - No worsening (defined as an increase of ≥0.3 points from baseline) in PGA.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    - To evaluate the efficacy of LY2127399 120 mg Q4W + SoC or 120 mg Q2W + SoC compared to placebo + SoC from baseline to Week 52
    - To evaluate the impact of LY2127399 120 mg Q4W + SoC or 120 mg Q2W + SoC compared to placebo + SoC from baseline to Week 52 on key patient-reported outcomes (PROs)
    - To evaluate the safety and tolerability of LY2127399 120 mg Q4W + SoC or 120 mg Q2W + SoC compared to placebo + SoC.
    - To characterize the time course of change in absolute B cell counts and changes in serum Ig levels to treatment with LY2127399 versus placebo over the study period.
    - To characterize the population PK of LY2127399 and explore PK/pharmacodynamic (PD) relationships.
    - To assess the potential development of anti-LY2127399 antibodies and the impact on patient safety, efficacy, and LY2127399 PK.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
    [2] Have positive antinuclear antibodies (ANA)
    [3] Agree not to become pregnant throughout the course of the trial
    [4] Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at screening
    E.4Principal exclusion criteria
    [1] Have active severe Lupus kidney disease
    [2] Have active Central Nervous System or peripheral neurologic disease
    [3] Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
    [4] Have active or recent infection within 30 days of screening
    [5] Have had a serious infection within 90 days of randomization
    [6] Have evidence or test positive for Hepatitis B
    [7] Have Hepatitis C
    [8] Are human immunodeficiency virus (HIV) positive
    [9] Have evidence of active or latent tuberculosis (TB)
    [10] Presence of significant laboratory abnormalities at screening
    [11] Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
    [12] Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
    [13] Have changed your dose of antimalarial drug in the past 30 days
    [14] Have changed your dose of immunosuppressive drug in the past 90 days
    [15] Have previously received rituximab
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving an SLE Responder Index response at week 52


    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    - Proportion of patients able to decrease dose of prednisone or equivalent with no increase in disease activity at week 52
    - Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level
    - Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score
    - Time to first severe SLE flare (SFI)
    - Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks
    - Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores
    - Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQoL) composite and domain scores
    - Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares
    - Change from baseline to 52 week endpoint in PGA
    - Proportion of patients with an increase in corticosteroids dose at 52 weeks
    - Change from baseline to 52 weeks endpoint in SELENA-SLEDAI disease activity score
    - Proportion of patients achieving a response as measured by modified SRI with no BILAG A or no more than 1 BILAG B organ domain flares at 52 weeks
    - Change from baseline to 52 week endpoint BILAG numeric scores
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Dosing intervals of 120 mg every 2 weeks versus every 4 weeks
    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 Yes
    E.8.1.7.1Other trial design description
    3 arm study to investigate dosing intervals (2 weeks vs 4 weeks vs placebo)
    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 trial3
    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 EEA47
    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
    Austria
    Belarus
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Egypt
    Germany
    Guatemala
    Italy
    Japan
    Korea, Republic of
    Macedonia, the former Yugoslav Republic of
    Peru
    Philippines
    Poland
    Singapore
    Thailand
    Turkey
    Ukraine
    United States
    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
    End of study (trial) is the date of the last visit or last scheduled procedure 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 years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 1026
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 114
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 1140
    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)
    See protocol section 7.1 "Summary of Study Design" and section 10.3.5 "Safety-Related Biomarkers" for additional details on B cell follow-up.
    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 Decision2011-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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