<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04469062</url>
  </required_header>
  <id_info>
    <org_study_id>16825</org_study_id>
    <secondary_id>I6T-MC-AMBI</secondary_id>
    <secondary_id>2019-001653-99</secondary_id>
    <nct_id>NCT04469062</nct_id>
  </id_info>
  <brief_title>A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis</brief_title>
  <acronym>LUCENT-ACT</acronym>
  <official_title>A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate if study drug mirikizumab is safe and effective&#xD;
      compared to vedolizumab and placebo in participants with moderately to severely active&#xD;
      ulcerative colitis (UC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The trial was terminated secondary to a business decision, the original scientific question&#xD;
    rendered moot by the external scientific community.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 20, 2021</start_date>
  <completion_date type="Anticipated">June 5, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 13, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants in Histologic Remission</measure>
    <time_frame>Week 12</time_frame>
    <description>Histologic remission based on histology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Symptomatic Remission</measure>
    <time_frame>Week 52</time_frame>
    <description>Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Clinical Remission</measure>
    <time_frame>Week 52</time_frame>
    <description>Clinical remission based on MMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Endoscopic Remission</measure>
    <time_frame>Week 52</time_frame>
    <description>Endoscopic remission based on MMS ES.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Clinical Response</measure>
    <time_frame>Week 12</time_frame>
    <description>Clinical response based on MMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)</measure>
    <time_frame>Week 52</time_frame>
    <description>CS free remission without surgery based on clinical remission, symptomatic remission and no CS use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline</measure>
    <time_frame>Week 52</time_frame>
    <description>Percentage of participants with resolution of EIMs among those that had them at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Change from baseline on the IBDQ score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Undergoing Surgery for UC (Including Colectomy)</measure>
    <time_frame>Week 52</time_frame>
    <description>Percentage of participants undergoing surgery for UC (including colectomy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Hospitalized for UC</measure>
    <time_frame>Week 52</time_frame>
    <description>Percentage of participants hospitalized for UC.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Mirikizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mirikizumab administered intravenously (IV) and subcutaneously (SC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vedolizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vedolizumab administered IV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered SC and IV.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirikizumab IV</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Mirikizumab</arm_group_label>
    <other_name>LY3074828</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirikizumab SC</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Mirikizumab</arm_group_label>
    <other_name>LY3074828</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vedolizumab IV</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Vedolizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo IV</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo SC</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have a diagnosis of UC for at least 3 months prior to baseline&#xD;
&#xD;
          -  Participants must have a confirmed diagnosis of moderately or severely active UC, as&#xD;
             assessed by the modified Mayo score (MMS)&#xD;
&#xD;
          -  Participants must have demonstrated an inadequate response to, a loss of response to,&#xD;
             or an intolerance to conventional or to biologic therapy for UC&#xD;
&#xD;
          -  Participants must, if female, meet the contraception requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have a current diagnosis of Crohn's disease or inflammatory&#xD;
             bowel disease-unclassified (indeterminate colitis)&#xD;
&#xD;
          -  Participants must not have had a previous colectomy&#xD;
&#xD;
          -  Participants must not have current evidence of toxic megacolon&#xD;
&#xD;
          -  Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g.&#xD;
             risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab&#xD;
&#xD;
          -  Participants must not have prior clinical failure or intolerance to anti-IL12p40&#xD;
             antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and&#xD;
             natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab)&#xD;
             within 4 weeks prior to screening endoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/2CU7GWC1qkMxLL0Qo3HP8a</url>
    <description>A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interleukin-23 (IL-23) antibody</keyword>
  <keyword>IL-23p19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mirikizumab</mesh_term>
    <mesh_term>Vedolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469062
org study id: 16825
secondary id: I6T-MC-AMBI
secondary id: 2019-001653-99
nct id: NCT04469062
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate if study drug mirikizumab is safe and effective
      compared to vedolizumab and placebo in participants with moderately to severely active
      ulcerative colitis (UC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants in Histologic Remission
time frame: Week 12
description: Histologic remission based on histology.
measure: Percentage of Participants in Symptomatic Remission
time frame: Week 52
description: Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.
measure: Percentage of Participants in Clinical Remission
time frame: Week 52
description: Clinical remission based on MMS.
measure: Percentage of Participants in Endoscopic Remission
time frame: Week 52
description: Endoscopic remission based on MMS ES.
measure: Percentage of Participants with Clinical Response
time frame: Week 12
description: Clinical response based on MMS.
measure: Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)
time frame: Week 52
description: CS free remission without surgery based on clinical remission, symptomatic remission and no CS use.
measure: Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline
time frame: Week 52
description: Percentage of participants with resolution of EIMs among those that had them at baseline.
measure: Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
time frame: Baseline, Week 52
description: Change from baseline on the IBDQ score.
measure: Percentage of Participants Undergoing Surgery for UC (Including Colectomy)
time frame: Week 52
description: Percentage of participants undergoing surgery for UC (including colectomy).
measure: Percentage of Participants Hospitalized for UC
time frame: Week 52
description: Percentage of participants hospitalized for UC.
arm group label: Mirikizumab
arm group type: Experimental
description: Mirikizumab administered intravenously (IV) and subcutaneously (SC).
arm group label: Vedolizumab
arm group type: Active Comparator
description: Vedolizumab administered IV.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered SC and IV.
intervention type: Drug
intervention name: Mirikizumab IV
description: Administered IV
arm group label: Mirikizumab
other name: LY3074828
intervention type: Drug
intervention name: Mirikizumab SC
description: Administered SC
arm group label: Mirikizumab
other name: LY3074828
intervention type: Drug
intervention name: Vedolizumab IV
description: Administered IV
arm group label: Vedolizumab
intervention type: Drug
intervention name: Placebo IV
description: Administered IV
arm group label: Placebo
intervention type: Drug
intervention name: Placebo SC
description: Administered SC
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
url: https://trials.lillytrialguide.com/en-US/trial/2CU7GWC1qkMxLL0Qo3HP8a
description: A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Mirikizumab
mesh term: Vedolizumab
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/