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    Summary
    EudraCT Number:2018-004614-18
    Sponsor's Protocol Code Number:I6T-MC-AMAM
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-30
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-004614-18
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease
    Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato verso placebo e comparatore attivo, per valutare l'efficacia e la sicurezza di Mirikizumab in pazienti con malattia di Chron moderata o severa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease
    Studio per valutare l'efficacia e la sicurezza di Mirikizumab in pazienti affetti da Morbo di Chron attivo
    A.3.2Name or abbreviated title of the trial where available
    VIVID-1
    VIVID-1
    A.4.1Sponsor's protocol code numberI6T-MC-AMAM
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/130/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    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 codeIN 46285
    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 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.3.9.1CAS number 1884201-71-1
    D.3.9.2Current sponsor codeLY3074828
    D.3.9.4EV Substance CodeSUB177588
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 nameMIRIKIZUMAB
    D.3.2Product code [LY3074828]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMirikizumab
    D.3.9.1CAS number 1884201-71-1
    D.3.9.2Current sponsor codeLY3074828
    D.3.9.4EV Substance CodeSUB177588
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name STELARA 130 mg concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameUstekinumab
    D.3.2Product code [Ustekinumab]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Stelara 90 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameUstekinumab
    D.3.2Product code [Ustekinumab]
    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.3.8INN - Proposed INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 No
    D.IMP: 5
    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 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.3.9.1CAS number 1884201-71-1
    D.3.9.2Current sponsor codeLY3074828
    D.3.9.4EV Substance CodeSUB177588
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    D.8 Placebo: 4
    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
    moderately to severely active Crohn’s disease
    Morbo di Chron moderato o severo
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease
    morbo di Chron
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical efficacy of mirikizumab in partecipants with Crohn's disease
    Valutare l'efficacia clinica di mirikizumab nei partecipanti con Morbo di Crohn
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of mirikizumab on endoscopic and clinical improvement
    - To evaluate the efficacy of mirikizumab on quality of life.
    - To evaluate the efficacy of mirikizumab on biomarkers, PK, and PD
    - valutare l'efficacia di mirikizumab sul miglioramento endoscopico e clinico
    - Valutare l'efficacia di mirikizumab sulla qualità della vita
    - Valutare l'efficacia di mirikizumab su biomarcatori, PK e PD
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Title: An Open Label Addendum to the AMAM adult study to Assess Efficacy and Safety of Mirikizumab in the Induction and Maintenance of Remission in Adolescents (15 to <18 years of age) with Moderately to Severely Active Crohn's Disease (CD).
    Protocol Addendum of sub-study dated on 08Jun2020.
    Objective: To evaluate the safety and efficacy of miri in adolescents with CD.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: titolo: Un addendum in aperto allo studio AMAM sugli adulti per valutare l'efficacia e la sicurezza di Mirikizumab nell'induzione e nel mantenimento della remissione negli adolescenti (da 15 a <18 anni di età) con malattia di Crohn attiva da moderata a grave (CD)
    Protocol Addendum del sottostudio datato 08Jun2020.
    Obiettivo: valutare la sicurezza e l'efficacia di miri negli adolescenti con MC.
    E.3Principal inclusion criteria
    • Diagnosis of CD for at least 3 months prior to baseline
    • Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
    • Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
    • If female, subject must meet the contraception recommendations
    - diagnosi di CD da almeno 3 mesi prima del baseline
    -diagnosi di CD moderato/severo confermata e valutata tramite SF, AP score, and SES-CD
    -dimostrata intolleranza, perdita di risposta o risposta inadeguata alle terapie convenzionali o biologiche per CD
    -se soggetti di sesso femminile, i soggetti devono rispettare le raccomandazioni sulla contraccezione
    E.4Principal exclusion criteria
    • Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or short bowel syndrome
    • Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery.
    • Have a stoma, ileoanal pouch or ostomy.
    • Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
    • Have ever received any monoclonal antibodies binding IL-23
    -presenza di diagnosi attuale di colite ulcerativa, IBD-U (nota come colite indeterminata), o short bowel syndrome
    - stoma, una sacca ileonale o ostomia
    - Attualmente ha o si sospetta che abbia un ascesso. Gli ascessi cutanei e perianali recenti non portano a esclusione se drenati, adeguatamente trattati e risolti almeno 3 settimane prima del basale o 8 settimane prima del basale per ascessi intra-addominali, a condizione che non vi sia alcuna necessità anticipata di ulteriori interventi chirurgici
    -aver avuto una resezione intestinale entro 6 mesi, o qualsiasi altra chirurgia intra addominale o extra addominale entro 3 mesi dal baseline
    -aver mai ricevuto una qualsiasi terapia con anticorpi monoclonali che legano IL-23
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of Participants Achieving Endoscopic Response Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score [Time Frame: Week 52]
    2. Percentage of Participants Achieving Clinical Remission Clinical remission by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP) [Time Frame: Week 52]
    1. Percentuale di partecipanti che ottengono risposta endoscopica Risposta endoscopica basata sul punteggio endoscopico semplice per il punteggio totale della malattia di Crohn (SES-CD) [Intervallo di tempo: settimana 52]
    2. Percentuale di partecipanti che raggiungono la remissione clinica La remissione clinica per paziente refertato risultato (PRO) basato sulla frequenza delle feci (SF) e dolore addominale (AP) [Time Frame: Week 52]
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    settimana 52
    E.5.2Secondary end point(s)
    3. Percentage of Participants Achieving Endoscopic Remission Endoscopic remission based on SES-CD total score [Time Frame: Week 52]
    4. Percentage of Participants Achieving Clinical Remission or Endoscopic Remission who were Corticosteroid Free Clinical remission by PRO based on SF and AP and endoscopic remission based on SES-CD total score [Time Frame: Week 52]
    5. Percentage of Participants Achieving Clinical Remission Clinical remission by PRO is based on SF and AP [Time Frame: Week 12]
    6. Percentage of Participants Achieving Clinical Remission Clinical remission based on CDAI [Time Frame: Week 52]
    7. Change from Baseline in C-Reactive Protein Change from baseline in C-Reactive Protein [Time Frame: Baseline, Week 52]
    8. Change from Baseline in Fecal Calprotectin Change from baseline in fecal calprotectin [Time Frame: Baseline, Week 52]
    9. Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn’s Disease
    Percentage of participants with EIMs of Crohn’s Disease [Time Frame: Week 52]
    10. Percentage of Participants with Fistulae Response Percentage of participants with fistulae response [Time Frame: Week 52]
    11. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab
    PK: AUC of mirikizumab [Time Frame: Baseline through Week 52]
    12. Change from Baseline in Health Related Quality of Life Health related quality of life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score [Time Frame: Baseline, Week 52]
    3. Percentuale di partecipanti che raggiungono la remissione endoscopica Remissione endoscopica basata sul punteggio totale SES-CD [Time Frame: Week 52]
    4. Percentuale di partecipanti che ottengono la remissione clinica o la remissione endoscopica che erano corticosteroide Libera remissione clinica di PRO basata su SF e AP e sulla remissione endoscopica basata sul punteggio totale SES-CD [Time Frame: Week 52]
    5. Percentuale di partecipanti che ottengono la remissione clinica La remissione clinica di PRO si basa su SF e AP [Time Frame: Week 12]
    6. Percentuale di partecipanti che raggiungono la remissione clinica Remissione clinica basata su CDAI [Time Frame: Week 52]
    7. Variazione dal valore basale nel cambiamento di proteina C-reattiva [Tempo fotogramma: linea di base, settimana 52]
    8. Cambiamento rispetto al basale nella Calprotectina fecale [Time Frame: Baseline, Week 52]
    9. Percentuale di partecipanti con manifestazioni extraintestinali (EIM) della malattia di Crohn
    Percentuale di partecipanti con EIMs of Crohn's Disease [Time Frame: Week 52]
    10. Percentuale di partecipanti con risposta alle fistole [Time Frame: Week 52]
    11. Farmacocinetica (PK): area sotto la curva del tempo di concentrazione (AUC) di Mirikizumab [Time Frame: Baseline through Week 52]
    12. Cambiamento rispetto al basale della qualità della vita correlata alla salute Qualità della vita correlata alla salute sulla base del punteggio del questionario sulla malattia infiammatoria delle viscere intestinali (IBDQ) [Time Frame: Baseline, Week 52]
    E.5.2.1Timepoint(s) of evaluation of this end point
    secondary endpoint [3, 4, 6, 9, 10] Timepoints: Week 52
    secondary endpoint [5] Timepoints: Week 12
    secondary endpoint [7, 8, 11, 12] Timepoints: Baseline - Week 52

    secondary endpoint [3, 4, 6, 9, 10] Timepoints: Week 52
    secondary endpoint [5] Timepoints: Week 12
    secondary endpoint [7, 8, 11, 12] Timepoints: Baseline - 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 No
    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.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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ustekinumab
    Ustekinumab
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA294
    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 Information not present in EudraCT
    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
    Brazil
    Canada
    China
    India
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Croatia
    Denmark
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Romania
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    LVLS
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1045
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 1150
    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)
    Participants who complete Study I6T-MC-AMAM (AMAM) through Visit 17 will be given the option to enroll in Study I6T-MC-AMAX (AMAX) if they are eligible. Participants who do not meet enrollment criteria for Study AMAX or who do not choose to participate in Study AMAX will return for two post-treatment follow-up visits in Study AMAM. The first such follow-up visit will be 4 weeks after the last dose (V801). The second such follow-up visit will be from 12 to 16 weeks after the last dose (V802).
    I partecipanti che completano lo studio AMAM con la Visita 17 avranno la possibilità di proseguire con lo Studio I6T-MC-AMAX (AMAX) se idonei. I partecipanti che non soddisfano i criteri di iscrizione per lo Studio AMAX o che non scelgono di partecipare allo studio AMAX torneranno per2visite di FU post-trattamento nello studio AMAM. La1visita di controllo di questo tipo sarà4settimane dopo l'ultima dose (V801). La2visita di controllo di questo tipo sarà da12a16sett dopo l'ultima dose(V802).
    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 Decision2019-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-16
    P. End of Trial
    P.End of Trial StatusOngoing
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