Trial Details
Not RecruitingBasic Information
| Clinical ID | c2725 |
|---|---|
| Identifier | CTRI/2018/10/015908 |
| Trial 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__ - LUCENT 1 |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Health Condition 1: K519- Ulcerative colitis, unspecified__ |
| Interventions | Intervention1: blinded intravenous administration of 300 mg mirikizumab: Patients will be randomized with 3:1 ratio to receive blinded Intravenous Administration Duration of treatment with the investigational product is 12 weeks. Intervention2: Experimental Mirikizumab administered intravenously (IV): Drug: Mirikizumab Administered IV Control Intervention1: placebo Patients will be randomized with 3:1 ratio to receive blinded Intravenous Administration of: every 4 weeks at Weeks 0, 4, and 8 Duration of treatment with the investigational product is 12 weeks Control Intervention2: Placebo Comparator: Placebo administered IV. : Drug: Placebo Administered IV |
Participant Information
| Sponsor | Eli Lilly and Company Lilly |
|---|---|
| City | - |
| Country/Region | Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czech Republic;Denmark;France;Germany;Hungary;India;Ireland;Italy;Japan;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Republic of Korea;Romania;Russia;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom;United States |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | - |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | 2025-04-24 |
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| Primary Completion Date | - |
| Completion Date | - |