A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)
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|ClinicalTrials.gov Identifier: NCT04469062|
Recruitment Status : Not yet recruiting
First Posted : July 13, 2020
Last Update Posted : November 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Mirikizumab IV Drug: Mirikizumab SC Drug: Vedolizumab IV Drug: Placebo IV Drug: Placebo SC||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Estimated Study Start Date :||April 20, 2021|
|Estimated Primary Completion Date :||March 13, 2024|
|Estimated Study Completion Date :||June 5, 2024|
Mirikizumab administered intravenously (IV) and subcutaneously (SC).
Drug: Mirikizumab IV
Other Name: LY3074828
Drug: Mirikizumab SC
Other Name: LY3074828
Active Comparator: Vedolizumab
Vedolizumab administered IV.
Drug: Vedolizumab IV
Placebo Comparator: Placebo
Placebo administered SC and IV.
Drug: Placebo IV
Drug: Placebo SC
- Percentage of Participants in Histologic Remission [ Time Frame: Week 12 ]Histologic remission based on histology.
- Percentage of Participants in Symptomatic Remission [ Time Frame: Week 52 ]Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.
- Percentage of Participants in Clinical Remission [ Time Frame: Week 52 ]Clinical remission based on MMS.
- Percentage of Participants in Endoscopic Remission [ Time Frame: Week 52 ]Endoscopic remission based on MMS ES.
- Percentage of Participants with Clinical Response [ Time Frame: Week 12 ]Clinical response based on MMS.
- Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline) [ Time Frame: Week 52 ]CS free remission without surgery based on clinical remission, symptomatic remission and no CS use.
- Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline [ Time Frame: Week 52 ]Percentage of participants with resolution of EIMs among those that had them at baseline.
- Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Baseline, Week 52 ]Change from baseline on the IBDQ score.
- Percentage of Participants Undergoing Surgery for UC (Including Colectomy) [ Time Frame: Week 52 ]Percentage of participants undergoing surgery for UC (including colectomy).
- Percentage of Participants Hospitalized for UC [ Time Frame: Week 52 ]Percentage of participants hospitalized for UC.
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): NCT04469062
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||Clinicaltrials.firstname.lastname@example.org|
|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|