Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-001098-34
    Sponsor's Protocol Code Number:I6T-MC-AMAF
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-01
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-001098-34
    A.3Full title of the trial
    Protocol I6T-MC-AMAF
    A Phase 2, Multicenter, Randomized, Parallel-arm, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study in Moderate to Severe Plaque Psoriasis
    A.4.1Sponsor's protocol code numberI6T-MC-AMAF
    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 Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    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 nameLY3074828
    D.3.4Pharmaceutical form Lyophilisate 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 INNmirikizumab
    D.3.9.3Other descriptive nameLY3074828
    D.3.9.4EV Substance CodeSUB177588
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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
    Moderate to Severe Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    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 treatment with LY3074828 is superior to placebo in inducing PASI 90 response at Week 16 in subjects with moderate to severe plaque psoriasis
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of treatment with LY3074828
    To evaluate the efficacy of treatment with LY3074828 compared to placebo in inducing PASI 100 and PASI 75 at week 16
    To evaluate the efficacy of treatment with LY3074828 compared to placebo in inducing sPGA 0 (clear) and sPGA 0/1 at week 16
    To evaluate the effect of LY3074828 on patient reported outcome measures: Psoriasis Symptom Scale, Patient Global Assessment, DLQI, and SF-36 at Week 16
    To characterize the long term efficacy of LY3074828 on the PASI 100, PASI 90 and PASI 75 responses at Week 52, 104 and 120
    To characterize the long term efficacy of LY3074828 on patient reported outcome measures Psoriasis Symptom Scale, Patient Global Assessment, DLQI, and SF-36 at Weeks 52, 104, and 120
    To characterize the PK of LY3074828
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Present with chronic plaque psoriasis,
    1) plaque psoriasis involving ≥10% body surface area and absolute PASI score ≥12 in affected skin
    2) sPGA score of ≥3
    3) are willing and able to undergo punch biopsies
    • are ≥18 and ≤ 75 years of age
    • have an adequate organ function

    are ≥18 and ≤ 75 years of age
    E.4Principal exclusion criteria
    • have an abnormality in the 12-lead electrocardiogram (ECG) that, in the
    opinion of the investigator, increases the risks associated with participating in
    the study
    • Have presence or history within 12 months prior to screening of significant
    uncontrolled cerebrocardiovascular, presence of respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of data
    • use of known drugs of abuse or known alcohol abuse
    • has Columbia Suicide Severity Rating Scale (C-SSRS) ideation within 1 month prior to screening or any suicidal behavior within 3 months prior to screening and either ideation or suicidal behavior during screening
    • evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
    • have hepatitis C or test positive hepatitis C virus at screening
    • have hepatitis B or test positive for hepatitis B virus (HBV) at screening
    • are women who are breastfeeding or plan to during study
    • have donated blood of >500 mL within 14 days prior to baseline
    • have had serious, opportunistic, or chronic/recurring infection within
    6 months prior to screening
    • have received a systemic (including oral) anti-infective agent for an infection
    within 28 days of screening
    • have evidence of active or latent tuberculosis (TB)
    • have received live vaccine(s) within 1 month of screening or intend to during the study
    • have significant allergies to humanized monoclonal antibodies or any components of the LY3074828 product formulation
    • 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 for 3 years and cervical
    carcinoma in situ, with no evidence of recurrence within the 5 years prior to
    randomization (Visit 2)
    • have any other skin conditions (excluding psoriasis) that would affect interpretation of the results
    • have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to randomization (Visit 2)
    • have received topical psoriasis treatment anthralin, calcipotriene, topical
    vitamin D derivatives, retinoids, tazarotene, pimecrolimus, tacrolimus,
    emollients and other nonprescription topical products containing urea, >3%
    salicylic acid, alpha- or beta-hydroxyl acids, or medicated shampoos within 14 days prior to randomization (Visit 2)
    • have received anti-tumor necrosis factor (TNF) biologics or anti-IL-17
    targeting biologics within 8 weeks prior to randomization (Visit 2)
    • have previous exposure to any biologic therapy targeting IL-23 either licensed or investigational
    • are unable or unwilling to avoid excessive sun exposure or use of tanning
    booths for at least 4 weeks prior to randomization (Visit 2) and during the study
    • are currently enrolled in any other clinical trial involving an investigational
    product or any other type of medical research judged not to be scientifically or
    medically compatible with this study
    •
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects achieving PASI 90
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 16 weeks
    E.5.2Secondary end point(s)
    The proportion of subjects achieving PASI 100 and PASI 75
    The proportion of subjects achieving sPGA 0 and sPGA 0/1
    The mean change from baseline for PSS, PatGA, DLQI, and SF-36

    The proportion of subjects achieving PASI 100, PASI 90, and PASI 75
    The mean change from baseline for PSS, PatGA, DLQI, and SF-36

    Clearance and volume of distribution
    Adverse event and discontinuation rates
    E.5.2.1Timepoint(s) of evaluation of this end point
    The first 3 are at 16 weeks
    The next 2 are for Weeks 52, 104, and 120
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 trial4
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Canada
    Japan
    United States
    Germany
    Poland
    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
    LVLS
    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 months0
    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 months8
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 200
    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)
    LY3074828 will not be made available to subjects after conclusion of the 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 Decision2016-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-08
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 05:33:15 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA