Phase 3
N=1,447
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT03518086 ↗Enrolled (actual)
1,447
Serious AEs
4.2%
Results posted
Feb 2022
Primary outcome: Primary: Percentage of Participants With Clinical Remission at Week 12 — 13.3; 24.2 percentage of participants — p=0.00006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mirikizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Remission at Week 12 |
13.3; 24.2 | 0.00006 sig |
| SECONDARY Percentage of Participants With Clinical Response at Week 12 |
42.2; 63.5 | <0.00001 sig |
| SECONDARY Percentage of Participants With Endoscopic Remission at Week 12 |
21.1; 36.3 | <0.00001 sig |
| SECONDARY Percentage of Participants With Symptomatic Remission at Week 12 |
27.9; 45.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Symptomatic Response at Week 12 |
52.4; 72.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Histologic Remission at Week 12 |
15.6; 29.3 | <0.001 sig |
| SECONDARY Percentage of Participants With Endoscopic Response at Week 12 |
36.1; 55.4 | <0.00001 sig |
| SECONDARY Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) |
-1.63; -2.59 | <0.00001 sig |
| SECONDARY Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score |
25.21; 38.42 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 in Fecal Calprotectin |
-939.69; -1875.29 | <0.001 sig |
| SECONDARY Pharmacokinetics (PK): Clearance of Mirikizumab |
0.0224 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03518086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.