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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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).

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    Summary
    EudraCT Number:2015-000190-12
    Sponsor's Protocol Code Number:I1F-MC-RHBP
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-20
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-000190-12
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in patients with moderate to severe plaque psoriasis comparing the efficacy and safety of taking a drug called Ixekizumab either every 4 weeks or every 2 weeks.
    A.4.1Sponsor's protocol code numberI1F-MC-RHBP
    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 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 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.3.9.2Current sponsor codeLY2439821
    D.3.9.4EV Substance CodeSUB30469
    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 in pre-filled syringe
    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
    Plaque 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 18.0
    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 compare the efficacy of continuous every 2-week (Q2W) dosing versus continuous every 4-week (Q4W) dosing of ixekizumab in the treatment of patients with moderate-to-severe plaque psoriasis (Ps), as measured by static Physician Global Assessment (sPGA) (0,1) and PASI 75 (75% improvement from baseline in the Psoriasis Area and Severity Index).
    E.2.2Secondary objectives of the trial
    •To compare the efficacy of Q4W step-up dosing to Q2W (Q4W/Q2W step-up) versus continuous Q4W dosing, as measured by sPGA (0,1)
    •To compare the efficacy of Q4W/Q2W step-up versus continuous Q4W dosing, as measured by PASI 75
    •To compare the efficacy of continuous Q2W dosing versus continuous Q4W dosing of ixekizumab, as measured by sPGA (0).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A blood sample will be collected for pharmacogenetic analysis where local regulations and ERBs allow
    E.3Principal inclusion criteria
    [1]Present with chronic plaque Ps based on a diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline as determined by the investigator.
    [2]Have ≥10% body surface area (BSA) involvement at screening and baseline.
    [3]Have both an sPGA score of ≥3 and PASI score of ≥12 at screening and baseline.
    [4]Are a candidate for phototherapy and/or systemic therapy.
    [5]Are male or female patients 18 years or older.
    [6]If a male patient, patient agrees to use a reliable method of birth control during the study.
    [7]If a female patient:
    Are women of childbearing potential who are determined to be negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks following the last dose of investigational product, whichever is longer. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel.
    or
    Are women of non-childbearing potential, defined as:
    Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation);
    or
    Women who are ≥60 years of age
    or
    Women ≥40 and <60 years of age who have had a cessation of menses for ≥12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (≥40 mIU/mL).
    E.4Principal exclusion criteria
    [9]Have predominant pattern of pustular, erythrodermic, and/or guttate forms of Ps
    [10]Have a history of drug-induced Ps
    [11]Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study, per investigator assessment
    [12]Have had any of the following therapies within 4 weeks prior to baseline: systemic non-biologic Ps therapy (including, but not limited to, psoralens and ultraviolet A [PUVA] light therapy; cyclosporine; corticosteroids; Methotrexate; apremilast; tofacitinib; oral retinoids; mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; azathioprine; fumaric acid derivatives; or 1, 25 dihydroxy vitamin D3 and analogs) or phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing) or topical Ps therapy with psoralens.
    or
    Have had any of the following therapies within 2 weeks prior to baseline: topical Ps treatment (including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, emollients, and other non-prescription topical products containing salicylic acid, or alpha- or beta-hydroxyl acids, and medicated shampoos [for example, those that contain corticosteroids, coal tar, or vitamin D3 analogs])
    Exceptions: topical steroids will be permitted for use limited to the face, axilla, and/or genitalia
    [13]Concurrent or recent use of any biologic agent within the following washout periods prior to baseline: etanercept <28 days; infliximab or adalimumab <60 days; golimumab <90 days; ustekinumab <8 months; rituximab <12 months; secukinumab <5 months; or any other biologic agent <5 half-lives
    [14]Have ever received natalizumab or other agents that target alpha-4-integrin
    [15]Have previously failed to respond to an IL-17 antagonist, per investigator assessment
    [16]Have previously completed or withdrawn from this study, or participated in any other study with ixekizumab
    [17]Had a live vaccination within 12 weeks prior to baseline, or intend to have a live vaccination during the course of the study or within 12 weeks of completing treatment in this study, or have participated in a vaccine clinical study within 12 weeks prior to baseline. Investigators should review the vaccination status of their patients and follow the local guidelines for adult vaccination with non-live vaccines intended to prevent infectious disease prior to therapy
    [18]Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to baseline (Week 0), or intend to have this vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
    [19]Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study.
    [20]Are currently enrolled in, have participated, or discontinued from a clinical trial involving an investigational product or nonapproved use of a drug or device within the last 30 days or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in 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 patients achieving sPGA (0,1)
    The proportion of patients achieving PASI 75
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52 (nonresponder imputation [NRI]).
    Week 52 (NRI).
    E.5.2Secondary end point(s)
    •Proportion of patients achieving sPGA (0,1)
    •Proportion of patients achieving PASI 75
    •Proportion of patients achieving sPGA (0)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52 (NRI)
    Week 52 (NRI)
    Week 52 (NRI).
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    N/A
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    same product (ixekizumab), different dose
    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 Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Australia
    Brazil
    Canada
    Czech Republic
    Germany
    Hungary
    Japan
    Korea, Republic of
    Mexico
    Poland
    Romania
    Taiwan
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 1107
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 93
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 285
    F.4.2.2In the whole clinical trial 1200
    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
    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 Decision2015-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-03
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