Phase 3
Completed N=801
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Source: ClinicalTrials.gov NCT03524092 ↗
Enrolled (actual)
801
Serious AEs
5.4%
Results posted
Nov 2022
Primary outcomePrimary: Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders) — 25.1; 49.9 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
3citations · ~3 / year
Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis.
Summary
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
Linked Publications (5)
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Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis.
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Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab.
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Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis.
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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.
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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 in Clinical Remission at Week 40 (Mirikizumab Induction Responders) |
25.1; 49.9 | <0.001 sig |
| SECONDARY Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders) |
29.1; 58.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Histologic Remission at Week 40 (Mirikizumab Induction Responders) |
24.6; 48.5 | <0.001 sig |
| SECONDARY Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders) |
39.7; 71.0 | <0.001 sig |
| SECONDARY Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders) |
40.8; 72.6 | <0.001 sig |
| SECONDARY Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders) |
49.2; 80.3 | <0.001 sig |
| SECONDARY Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders) |
24.51; 49.75 | <0.001 sig |
| SECONDARY Change From Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders) |
-1155.82; -1995.47 | <0.001 sig |
| SECONDARY Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders) |
-2.74; -3.80 | <0.001 sig |
| SECONDARY Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders) |
1.1; 0 | — |
| SECONDARY Pharmacokinetics (PK): Clearance of Mirikizumab |
0.0487 | — |
Eligibility Criteria
Inclusion Criteria
- Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- If female, must meet the contraception requirements.
Exclusion Criteria
- Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
- Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
- Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
- Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
- Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
- Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
Data sourced from ClinicalTrials.gov (NCT03524092) 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.