An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
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|ClinicalTrials.gov Identifier: NCT03518086|
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Mirikizumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Actual Study Start Date :||June 18, 2018|
|Estimated Primary Completion Date :||September 7, 2020|
|Estimated Study Completion Date :||December 29, 2021|
Mirikizumab administered intravenously (IV).
Other Name: LY3074828
Placebo Comparator: Placebo
Placebo administered IV.
- Percentage of Participants in Clinical Remission [ Time Frame: Week 12 ]Clinical remission based on the modified Mayo Score (MMS).
- Percentage of Participants in Clinical Response [ Time Frame: Week 12 ]Clinical response based on the MMS.
- Percentage of Participants in Endoscopic Remission [ Time Frame: Week 12 ]Endoscopic remission based on the MMS Endoscopic Subscore (ES).
- Percentage of Participants in Symptomatic Remission [ Time Frame: Week 12 ]Symptomatic remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) subscores.
- Percentage of Participants in Symptomatic Response [ Time Frame: Week 12 ]Symptomatic response based on MMS SF and RB subscores.
- Percentage of Participants with Mucosal Healing [ Time Frame: Week 12 ]Mucosal healing based on a histologic disease activity index.
- Percentage of Participants in Endoscopic Response [ Time Frame: Week 12 ]Endoscopic response based on the MMS ES.
- Change from Baseline to Week 12 in UC Symptoms: Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 12 ]UC symptoms based on NRS scores.
- Change from Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Week 12 ]Health Related Quality of Life based on IBDQ score.
- Change from Baseline to Week 12 in Fecal Calprotectin [ Time Frame: Baseline, Week 12 ]Change from baseline to Week 12 in fecal calprotectin.
- Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Weeks 0, 4, 8 and 12: Pre-Dose; Week 0 and 4: Up to 2 hour Post-Dose ]Clearance of Mirikizumab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518086
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||ClinicalTrials.email@example.com|
Show 513 Study Locations
|Study Director:||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)||Eli Lilly and Company|