Phase 3
Completed N=1,447
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Source: ClinicalTrials.gov NCT03518086 ↗Enrolled (actual)
1,447
Serious AEs
4.2%
Results posted
Feb 2022
Primary outcomePrimary: Percentage of Participants With Clinical Remission at Week 12 — 13.3; 24.2 percentage of participants — p=0.00006
◆ Published Evidence
Established
26citations · ~26 / year
Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.
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.
Linked Publications (5)
-
Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.
-
Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis.
-
Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab.
-
Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials.
-
Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With Moderately to Severely Active Ulcerative Colitis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.