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    Summary
    EudraCT Number:2018-004614-18
    Sponsor's Protocol Code Number:I6T-MC-AMAM
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-04
    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 ConcernedSpain - AEMPS
    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
    Estudio de fase 3, multicéntrico, aleatorizado, con enmascaramiento doble, comparativo con un placebo y un tratamiento activo y sin re-aleatorización para evaluar la eficacia y la seguridad de mirikizumab en pacientes con enfermedad de Crohn activa de moderada a grave
    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
    Estudio para evaluar la eficacia y la seguridad de mirikizumab en pacientes con enfermedad de Crohn activa
    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 No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 Cork Ltd
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressIsland House, Eastgate Road, Eastgate Business Park
    B.5.3.2Town/ cityLittle Island
    B.5.3.3Post code.
    B.5.3.4CountryIreland
    B.5.6E-mailensayosclinicos@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.3.9.3Other descriptive nameMIRIKIZUMAB
    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 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 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.3.9.3Other descriptive nameMIRIKIZUMAB
    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 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: 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.3.4Pharmaceutical 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.3.9.3Other descriptive nameUSTEKINUMAB
    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 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: 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.3.4Pharmaceutical 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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    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 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: 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.3.9.3Other descriptive nameMIRIKIZUMAB
    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 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 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 in pre-filled syringe
    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
    Enfermedad de Crohn activa de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease
    Enfermedad de Crohn
    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 whether treatment with mirikizumab is superior to placebo as assessed by endoscopic response at Week 52 and clinical remission by PRO at Week 52
    Evaluar si el tratamiento con mirikizumab es superior al placebo desde el punto de vista de la respuesta endoscópica en la semana 52 y la remisión clínica en la semana 52 de acuerdo con los RPP.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of treatment with mirikizumab compared to placebo in endoscopic response at Week 12
    - To evaluate the efficacy of treatment with mirikizumab compared to placebo in clinical remission by PRO at Week 12
    - To evaluate the efficacy of treatment with mirikizumab compared to placebo in endoscopic remission at Week 52
    - To evaluate the efficacy of treatment with mirikizumab compared to placebo in corticosteroid-free clinical remission by PRO or endoscopic remission at Week 52
    - To evaluate the efficacy of treatment with mirikizumab compared to placebo in the stability of clinical remission by PRO through Week 52
    - To evaluate the efficacy of treatment with mirikizumab compared to placebo in the durability of endoscopic response at Week 52
    - To evaluate whether mirikizumab is superior to ustekinumab in achieving endoscopic response at Week 52
    - To evaluate whether mirikizumab is noninferior to ustekinumab in clinical remission by CDAI at Week 52
    -Comp. la eficacia del tratamiento con mirikizumab (miri) vs. placebo según la respuesta endoscópica en la sem. 12.
    -Comp. la eficacia del tratamiento con miri vs. placebo según la remisión clínica en la sem. 12 de acuerdo con los RPP.
    -Comp. la eficacia del tratamiento con miri vs. placebo según la remisión endoscópica en la sem. 52.
    -Comp. la eficacia del tratamiento con miri vs. placebo según la remisión clínica sin admin. de corticoesteroides en función de los RPP o de la remisión endoscópica en la sem. 52.
    -Comp. la eficacia del tratamiento con miri vs. placebo según la estabilidad de la remisión clínica hasta la sem. 52, en función de los RPP.
    -Comp. la eficacia del tratamiento con miri vs. placebo según la duración de la remisión endoscópica en la sem. 52.
    -Evaluar si miri es superior a ustekinumab según la consecución de la respuesta endoscópica en la sem. 52.
    -Evaluar si miri no es inferior a ustekinumab según la remisión clínica de acuerdo con el CDAI en la sem. 52.
    E.2.3Trial contains a sub-study No
    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
    • Diagnóstico de EC al menos 3 meses antes del período inicial.
    • Diagnóstico confirmado de EC moderada a grave, de acuerdo con la frecuencia de las deposiciones (FD), la puntuación relativa al dolor abdominal (DA) y la SES-CD.
    • Intolerancia, pérdida de respuesta o respuesta insuficiente (demostradas) al tratamiento convencional o biológico para la EC.
    • Las mujeres deben cumplir los requisitos relativos a las medidas anticonceptivas.
    E.4Principal exclusion criteria
    • Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis), abdominal or perianal abscess or short bowel syndrome
    • Have a stoma 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
    • Presentar en la actualidad diagnóstico de colitis ulcerosa, enfermedad inflamatoria intestinal inclasificable (EII-IN) (anteriormente denominada “colitis indeterminada”), absceso abdominal o perianal o síndrome del intestino corto.
    • Presentar un estoma u ostomía.
    • Haberse sometido a resección intestinal en el transcurso de los 6 meses anteriores al período inicial, o a cualquier tipo de cirugía intra o extraabdominal en el transcurso de los 3 meses anteriores a dicho período.
    • Haber recibido anteriormente cualquier anticuerpo monoclonal dirigido a la 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. Porcentaje de pacientes que alcancen la respuesta endoscópica de acuerdo con la puntuación endoscópica simple total para la enfermedad de Crohn (SES-CD) (intervalo de tiempo: semana 52).
    2. Porcentaje de pacientes que alcancen la remisión clínica de acuerdo con los resultados percibidos por el paciente (RPP) relativos a la frecuencia de las deposiciones (FD) y el dolor abdominal (DA) (intervalo de tiempo: semana 52).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 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. Porcentaje de pacientes que alcancen la remisión endoscópica de acuerdo con la puntuación total SES-CD (intervalo de tiempo: semana 52).
    4. Porcentaje de pacientes que alcancen la remisión clínica o endoscópica de entre los que habían alcanzado la remisión clínica sin la administración de corticoesteroides (de acuerdo con los RPP relativos a la FD y al DA) y la remisión endoscópica (de acuerdo con la puntuación total SES-CD) (intervalo de tiempo: semana 52).
    5. Porcentaje de pacientes que alcancen la remisión clínica de acuerdo con los RPP relativos a la FD y el DA (intervalo de tiempo: semana 12).
    6. Porcentaje de pacientes que alcancen la remisión clínica de acuerdo con el CDAI (intervalo de tiempo: semana 52).
    7. Variación respecto al período inicial en la concentración de proteína C-reactiva (intervalo de tiempo: período inicial, semana 52).
    8. Variación respecto al período inicial en la concentración de calprotectina fecal (intervalo de tiempo: período inicial, semana 52).
    9. Porcentaje de participantes con manifestaciones extraintestinales (MEI) de la enfermedad de Crohn.
    Porcentaje de participantes con MEI de la enfermedad de Crohn (intervalo de tiempo: semana 52).
    10. Porcentaje de participantes con respuesta de la fístula (intervalo de tiempo: semana 52).
    11. Farmacocinética (FC): Área bajo la curva (ABC) de concentración-tiempo de mirikizumab; FC: ABC de mirikizumab (intervalo de tiempo: desde el período inicial hasta la semana 52).
    12. Variación respecto al período inicial en la calidad de vida relacionada con la salud de acuerdo con la puntuación del cuestionario sobre la enfermedad inflamatoria intestinal (IBDQ) (intervalo de tiempo: período inicial, semana 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
    Criterio secundario de valoración [3, 4, 6, 9, 10] Puntos temporales: semana 52
    Criterio secundario de valoración [5] Puntos temporales: semana 12
    Criterio secundario de valoración [7, 8, 11, 12] Puntos temporales: período inicial – semana 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
    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 concerned7
    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 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
    Austria
    Belgium
    Brazil
    Canada
    China
    Croatia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    Última visita del último paciente.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 1100
    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).
    Los participantes que completen la visita 17 del estudio I6T-MC-AMAM (AMAM) y se consideren idóneos tendrán la opción de participar en el estudio I6T-MC-AMAX (AMAX). Los que no cumplan los criterios de reclutamiento de AMAX o decidan no participar realizarán las dos visitas de seguimiento post tratamiento de AMAM, la primera de las cuales tendrá lugar 4 semanas tras la última dosis (V801). La segunda visita de seguimiento se llevará a cabo entre 12 y 16 semanas después de la última dosis (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 Decision2019-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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