An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Purpose
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
Condition
- Ulcerative Colitis
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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).
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo Intravenous (IV) Every 4 Weeks (Q4W) |
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
Experimental 300 Milligram (mg) Mirikizumab IV Q4W |
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
Placebo Comparator Placebo IV Q4W Maximum Extended Enrollment (ME2) |
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
Experimental 300 mg Mirikizumab IV Q4W ME2 |
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company