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    Summary
    EudraCT Number:2015-003123-57
    Sponsor's Protocol Code Number:I6T-MC-AMAC
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-05
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2015-003123-57
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis
    Multicentrická, randomizovaná, dvojitě zaslepená, paralelní, placebem kontrolovaná studie fáze 2 hodnotící přípravek LY3074828 u subjektů se středně těžkou až těžkou ulcerózní kolitidou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis
    A.3.2Name or abbreviated title of the trial where available
    AMAC
    A.4.1Sponsor's protocol code numberI6T-MC-AMAC
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02589665
    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 nameMirikizumab
    D.3.2Product code LY3074828
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.2Current sponsor codeLY3074828
    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/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 treatment with LY3074828 is superior to placebo in inducing clinical remission at Week 12 (as defined in Section 10.1.1 of the protocol) in subjects with moderate to severe UC.
    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 in inducing a clinical response at Week 12 (as defined in Section 10.1.2 of the protocol)
    - To evaluate endoscopic remission at Week 12 and Week 52 (as defined in Section 10.1.2)
    - To evaluate the effect of maintenance treatment with LY3074828 on the durability of clinical remission, endoscopic remission, and response at Week 52
    - To evaluate the effect of LY3074828 on health outcomes/quality of life measures (including: Inflammatory Bowel Disease Questionnaire [IBDQ] score, 36-Item Short Form Health Survey [SF-36] score, Patient’s Global Impressions of Severity [PGI-S] score, and Patient’s Global Impressions of Improvement [PGI-I] score).
    - To characterize the PK profile of LY3074828
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) have given written informed consent approved by the ERB (ethical review board) governing the site
    (2) are male or female subjects ≥18 and ≤65 years of age at the time of initial screening
    (2a) Male subjects agree to use a reliable method of birth control during the study and for 3 months, which is greater than 5 half-lives, after the last dose of investigational product.
    (2b) female subjects:
    - are women of childbearing potential whose serum pregnancy test results are negative and who agree to use a reliable method of birth control (eg, condom, sponge, or diaphragm combined with spermicidal foam, gel, or cream; ongoing hormonal contraception [oral, intramuscular, depot, or transdermal], such as Depo-Provera, Evra, or NuvaRing; an intrauterine device; or complete abstinence from sexual intercourse with men) during the study and for 3 months after the last dose of the investigational product
    OR
    - are not women of childbearing potential, defined as having: bilateral oophorectomy, tubal ligation, or hysterectomy at least 6 weeks before screening; spontaneous amenorrhea for ≥ 12 months, not induced by a medical condition or medications; or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone level greater than 40 mIU/mL at screening
    (3) venous access sufficient to allow blood sampling and IV administration (if applicable), as per the protocol
    (4) have had a diagnosis of UC for ≥3 months before baseline (endoscopic evidence corroborated by a histopathology report); a biopsy for a local histopathology evaluation (to obtain a report) can be obtained during the baseline endoscopy procedure if a histopathology report is not available
    (5) have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
    (6) have evidence of UC extending proximal to the rectum (≥15 cm of involved colon)
    (7) have documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before baseline (may be performed during screening) for subjects with pancolitis of >8 years’ duration or left-sided colitis of >12 years’ duration
    (7a) up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
    (8) subjects must either:
    (8a) be naive to biologic therapy (such as TNF antagonists, vedolizumab, or experimental biologics) and have at least 1 of the following:
    - inadequate response or failure to tolerate current treatment with oral or IV corticosteroids or immunomodulators (6-MP or AZA) or
    - history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC)
    OR
    (8b) have received treatment with 1 or more biologic agents (such as TNF antagonists, vedolizumab, or experimental UC biologics) with or without documented history of failure to respond to or tolerate such treatment. The biologic treatment must have been discontinued according to the following timelines:
    - anti-TNF therapy at least 8 weeks before baseline
    - vedolizumab treatment at least 12 weeks before baseline
    - experimental biologic UC therapy at least 8 weeks before baseline
    (9) may be receiving a therapeutic dosage of the following drugs:
    (9a) oral 5-ASA compounds: if the prescribed dose has been stable for at least 2 weeks before screening endoscopy
    (9b) oral corticosteroid therapy (prednisone ≤20 mg/d or equivalent): if the prescribed dose has been stable for at least the 2 weeks before screening endoscopy
    (9c) AZA or 6-MP: if the prescribed dose has been stable for at least 8 weeks before baseline
    (10) are willing and able to complete the scheduled study assessments, including endoscopy
    (11) have clinically acceptable laboratory results at screening, as assessed by the investigator, including:
    (11a) hematologic: absolute neutrophil count ≥1.5 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin level ≥10.0 g/dL, lymphocyte count >500 cells/μL, and total white blood cell count ≥3.0 × 10^9/L
    (11b) chemistry: serum creatinine, total bilirubin level, alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels ≤2× upper limit of normal (ULN)
    E.4Principal exclusion criteria
    (12) have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or CD
    (13) have had surgery for treatment of UC or are likely to require surgery for UC during the study
    (14) have received any of the following for treatment of UC:
    (14a) cyclosporine or thalidomide within 30 days of screening endoscopy
    (14b) corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-ASA within 30 days of screening endoscopy
    (14c) have used apheresis (eg, Adacolumn apheresis) ≤2 weeks before screening endoscopy
    (15) have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational
    (16) have been treated with any investigational drug for UC within 30 days or 5 half-lives of the drug (whichever is longer) before the initial screening visit (Visit 1), OR with interferon therapy within 8 weeks before baseline
    (17) have evidence of abdominal abscess or toxic megacolon during screening
    (18) have extensive colonic resection, subtotal or total colectomy, ileostomy, colostomy, or fixed symptomatic stenosis of the intestine
    (19) have evidence of active or latent TB (refer to Section 10.3.2.2 of the protocol for details on full TB exclusion criteria)
    (20) have had any malignancy within 5 years of screening, except for basal cell or squamous epithelial carcinoma of the skin that has been resected with no evidence of metastatic disease for at least 3 years OR cervical carcinoma in situ with no evidence of recurrence within 5 years of screening
    (21) are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    (22) are Lilly employees or employees of third -party organizations (TPOs) involved with the study
    (23) are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device, OR are concurrently enrolled in any other type of medical research not scientifically or medically compatible with this study, per investigator judgment
    (24) have previously completed or withdrawn from this study or any other study investigating LY3074828. This criterion does not apply to subjects undergoing rescreening procedures.
    (25) have received live, attenuated vaccine(s) within 2 months of screening or intend to receive such during the study; vaccines should be avoided for 2 months after the last dose of study drug. Uses of nonlive (inactivated) vaccinations are allowed for all subjects
    (26) have HIV/AIDS or test positive for human immunodeficiency virus antibodies at screening
    (27) have hepatitis B or test positive for hepatitis B virus (HBV) at screening, defined as: (1) positive for hepatitis B surface antigen or (2) positive for anti–hepatitis B core antibody (HBcAb+) and positive confirmatory polymerase chain reaction (PCR) for HBV, regardless of anti–hepatitis B surface antibody status
    (28) have hepatitis C or test positive hepatitis C virus at screening, defined as: positive result for hepatitis C antibody and positive confirmatory PCR test for hepatitis C virus
    (29) had Clostridium difficile infection within 30 days of screening endoscopy or test positive at screening or other intestinal pathogen with 30 days before screening endoscopy. Subject must not have signs of an ongoing infection related to an intestinal pathogen.
    (30) have any clinically significant extra-intestinal infection or opportunistic, chronic, or recurring infection within 6 months before screening. Examples include but are not limited to infections requiring IV antibiotics, hospitalization, or prolonged treatment.
    (31) are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject’s safety or confound data interpretation
    (32) Exclusion Criterion (32) applies to study sites in Japan only. For study sites in Japan, see the Japan protocol addendum.
    (33) are pregnant, lactating, or planning pregnancy (either men or women) while enrolled in the study or within 4 months after receiving the last dose of study agent
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is clinical remission at Week 12. Clinical remission is defined as having achieved the following Mayo subscores at Week 12: a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with 1 point decrease from baseline), and endoscopy subscore of 0 or 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are clinical response at Week 12 and endoscopic remission at Week 12 and Week 52. Clinical response is defined as having achieved at Week 12 a decrease in 9-point Mayo subscore (rectal bleeding, stool frequency, and endoscopy) inclusive of ≥2 points and ≥35% from baseline with either a decrease of rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission is defined as having achieved a Mayo endoscopic subscore of 0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and Week 52
    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
    tolerability, health outcomes, epigenetic
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Australia
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Georgia
    Hungary
    Japan
    Lithuania
    Moldova, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Ukraine
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months10
    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 months0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 240
    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)
    After a patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physicians.
    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 Decision2016-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-07
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