Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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25 March 2024 |
Main ID: |
NCT03518086 |
Date of registration:
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04/05/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
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Scientific title:
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A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) |
Date of first enrolment:
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June 18, 2018 |
Target sample size:
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1281 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03518086 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Canada
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China
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Croatia
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Czechia
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Denmark
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France
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Germany
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Hungary
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India
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Ireland
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Israel
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Italy
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Japan
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Korea, Republic of
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Latvia
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Lithuania
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Malaysia
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Mexico
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Netherlands
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Poland
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Romania
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Russian Federation
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Saudi Arabia
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Serbia
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Slovakia
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Spain
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Switzerland
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Taiwan
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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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) |
Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of UC for at least 3 months prior to baseline.
- Confirmed diagnosis of moderately or severely active UC, as assessed by the modified
Mayo score (MMS).
- Demonstrated an inadequate response to, a loss of response to, or an intolerance to
conventional or to biologic therapy for UC.
- If female, must meet the contraception requirements.
Exclusion Criteria:
- Participants with a current diagnosis of Crohn's disease or inflammatory bowel
disease-unclassified (indeterminate colitis).
- Participants with a previous colectomy.
- Participants with current evidence of toxic megacolon.
- Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19
antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Placebo
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Drug: Mirikizumab
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Primary Outcome(s)
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Percentage of Participants With Clinical Remission at Week 12
[Time Frame: Week 12]
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Secondary Outcome(s)
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Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
[Time Frame: Baseline, Week 12]
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Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
[Time Frame: Baseline, Week 12]
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Percentage of Participants With Endoscopic Response at Week 12
[Time Frame: Week 12]
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Pharmacokinetics (PK): Clearance of Mirikizumab
[Time Frame: Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12]
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Percentage of Participants With Endoscopic Remission at Week 12
[Time Frame: Week 12]
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Percentage of Participants With Clinical Response at Week 12
[Time Frame: Week 12]
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Percentage of Participants With Histologic Remission at Week 12
[Time Frame: Week 12]
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Percentage of Participants With Symptomatic Response at Week 12
[Time Frame: Week 12]
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Change From Baseline to Week 12 in Fecal Calprotectin
[Time Frame: Baseline, Week 12]
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Percentage of Participants With Symptomatic Remission at Week 12
[Time Frame: Week 12]
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Secondary ID(s)
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2017-003229-14
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16591
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I6T-MC-AMAN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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