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    Summary
    EudraCT Number:2010-018948-14
    Sponsor's Protocol Code Number:I1F-MC-RHAJ(d)
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-05-31
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-018948-14
    A.3Full title of the trial
    A Dose-Ranging And Efficacy Study of LY2439821 (an Anti-IL-17 Antibody) in Patients With Moderate-To-Severe Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study in Patients With Moderate-to-Severe Psoriasis
    A.4.1Sponsor's protocol code numberI1F-MC-RHAJ(d)
    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 and Company
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street Address.
    B.5.3.2Town/ city.
    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 nameixekizumab
    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 INNIxekizumab
    D.3.9.1CAS number 1143503-69-8
    D.3.9.2Current sponsor codeLY2439821, ixekizumab
    D.3.9.3Other descriptive nameAnti-IL- 17 Monoclonal Antibody (Mab)
    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) 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 No
    D.IMP: 2
    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 nameIxekizumab
    D.3.2Product code LY2439821
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNIxekizumab
    D.3.9.1CAS number 1143503-69-8
    D.3.9.2Current sponsor codeLY2439821, ixekizumab
    D.3.9.3Other descriptive nameAnti-IL- 17 Monoclonal Antibody (Mab)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) 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 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
    Patients With Moderate-To-Severe Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis is a skin condition that causes red, raised scaly patches on the skin
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    The primary objective of this study is to test the hypothesis that at least 1 LY2439821 treatment group is superior to placebo in the proportion of adult patients with moderate-to-severe chronic plaque psoriasis who achieve a 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index (PASI 75) and to estimate the percentage PASI improvement by treatment using regression techniques.
    E.2.2Secondary objectives of the trial
    •To test the hypothesis that:
    - at least one LY2439821 treatment group is superior to placebo in the proportion of patients with a sPGA score of cleared (0) or minimal (1) with at least a 2 point improvement from baseline at W12
    - LY2439821 is superior to placebo in the sPGA at W 12 and to measure the response by treatment group
    •To evaluate the proportion of patients who achieve:
    - sPGA score of cleared (0) or minimal (1) at W20
    - 75% improvement from baseline in the PASI at W20
    •To explore:
    - relationships between LY2439821 dose regimens and health outcomes
    - immunogenicity as measured by anti-LY2439821 antibody titers
    - relationships between clinical response and systemic exposure across the dose regimens
    •To evaluate:
    - safety and tolerability of LY2439821
    - sustained efficacy in patients who experience treatment benefit at W20
    - LY2439821 pharmacokinetics after multiple doses
    - effect of long term LY2439821 treatment on disease severity as measured by PASI & sPGA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria Common to Both Part A and B:

    [1] Ambulatory male or female patients ≥18 years of age.
    [1a] Male patients:
    agree to use a reliable method of birth control during the study.
    [1b] Female patients:
    Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate (<1% per year) during the study.
    OR
    Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
    OR
    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] Present with chronic plaque psoriasis based on a diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization; at least 10% BSA involvement; and a PASI score of at least 12 at Visits 1 and 2
    [30] Are a candidate for systemic therapy.
    [31] Have a sPGA score of at least 3 at Visits 1 and 2.

    Inclusion Criterion Specific to Part B:

    [32] Patients who have completed the treatment period for Part A. A patient is defined as having completed the treatment period for Part A if he/she has completed at least through Week 20.

    Inclusion Criterion Specific to Part C
    [35] Patients who have completed the treatment period for Part B.
    E.4Principal exclusion criteria
    3. Have pustular, erythrodermic and/or guttate forms of psoriasis.
    4. Have had a clinically-significant flare of psoriasis during the 12 weeks prior to randomization.
    5. Have received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds or therapeutic sunbathing) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
    6. Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days, infliximab or adalimumab <56 days, alefacept <60 days, ustekinumab <8 months, or any other biologic agent <5 half-lives prior to baseline.
    7. Current or expected use of concomitant medications or treatments other than those listed in Section 9.8, unless approved by the sponsor.
    8. Are currently enrolled in, or have discontinued within the last 30 days (prior to Visit 1) from a clinical trial involving use of an investigational drug or device, or are currently enrolled in any other type of medical research not compatible with this study.
    9. Have previously completed or withdrawn from this study.
    10. Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical trial within 12 weeks prior to randomization.
    11. Have evidence of active infection, such as fever ≥38.0oC within 5 days of dosing.
    12. Have evidence of or test positive for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
    13. Are immunocompromised, have had a recent or current serious systemic or local infection (including infectious mononucleosis-like illness or herpes zoster), or have evidence of active or latent tuberculosis
    14. Have thyroid-stimulating hormone (TSH) outside of the laboratory’s reference range.
    15. Have a history of uncompensated heart failure, fluid overload, myocardial infarction, or evidence of ischemic heart disease or other serious cardiac disease within 12 weeks before randomization.
    16. Have a history of chronic liver disease, peripheral vascular disease or cerebrovascular disease, or epilepsy.
    17. Have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, could interfere with study conduct.
    18 Have uncontrolled arterial hypertension characterized by a repeated systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg.
    19 Have current or a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years.
    20 Have a history of atopy or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
    21 Have laboratory test values outside the reference range for the population or investigative site that are considered clinically significant by the investigator or have any of the following specific abnormalities:
    Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times ULN
    Hemoglobin <8.5 g/dL for male patients and <8.0 g/dL for female patients
    Total white blood cells (WBC) <3000 cells/µL
    Neutropenia (polymorphonuclear leukocytes <1500 cells/µL)
    Thrombocytopenia (platelets <100,000 /µL)
    22 Have ECG abnormalities obtained at Visit 1 that, in the opinion of the investigator, are clinically significant.
    23 Have donated blood of more than 500 mL within the last month.
    24 Have a history of chronic alcohol abuse or IV drug abuse in the past 2 years.
    25 Are unwilling or unable to maintain their normal pattern of alcohol, caffeine, smoking, and exercise from the start to the end of the study.
    26 Nursing females
    27 Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures.
    28 Are investigator site personnel directly affiliated with this study and/or their immediate families.
    29 Are Lilly employees or its designee’s employees.
    Specific to Part B:
    33 SAE during Part A considered possibly related.
    34 AE in part A that in the opinion of the PI could cause extension of treatment to be detrimental to patient.
    Specific to Part C
    36 SAE during Part B considered possibly related.
    37 AE in Part B that in the opinion of the PI could cause extension of treatment
    to be detrimental to patient.
    E.5 End points
    E.5.1Primary end point(s)
    primary end point a 75% improvement in PASI score (PASI 75).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    - Static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI).
    - Quality of life assessments based on patient reported outcomes over 12 and 20 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    through Week 20
    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 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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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 Yes
    E.8.1.7.1Other trial design description
    Part B&C: Open label treatment period
    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 trial5
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    Denmark
    United States
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 125
    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)
    Standard care
    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 Decision2010-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-02
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