Phase 3
Completed N=1,158
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Source: ClinicalTrials.gov NCT03926130 ↗Enrolled (actual)
1,158
Serious AEs
11.6%
Results posted
Dec 2024
Primary outcomePrimary: Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) — 9.0; 38.0 percentage of participants — p=<0.000001
◆ Published Evidence
Emerging
6citations · ~6 / year
A patient-reported outcome measure comprising the stool frequency and abdominal pain items from the Crohn's Disease Activity Index: psychometric evaluation in adults with Crohn's disease.
Summary
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
Linked Publications (5)
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A patient-reported outcome measure comprising the stool frequency and abdominal pain items from the Crohn's Disease Activity Index: psychometric evaluation in adults with Crohn's disease.
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The Urgency Numeric Rating Scale: Psychometric Evaluation in Adults with Crohn's Disease.
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Mirikizumab Improves Quality of Life and Work Productivity in Patients with Moderately to Severely Active Crohn's Disease: Results from the Phase 3 VIVID-1 Study.
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Bowel Urgency in Crohn's Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Study.
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Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn's disease: results from the phase 3 VIVID-1 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) |
9.0; 38.0 | <0.000001 sig |
| PRIMARY Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) |
19.6; 45.4 | <0.000001 sig |
| SECONDARY Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab) |
12.6; 32.5 | <0.000001 sig |
| SECONDARY Percentage of Adult Participants Achieving Endoscopic Response at Week 52 |
9; 48.4; 46.3 | <0.000001 sig |
| SECONDARY Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab) |
25.1; 37.7 | 0.001431 sig |
| SECONDARY Percentage of Adult Participants Achieving Clinical Remission at Week 52 |
19.6; 54.1; 48.4 | <0.000001 sig |
| SECONDARY Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab) |
4.0; 10.9 | 0.003414 sig |
| SECONDARY Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab) |
-1.58; -2.44 | 0.000011 sig |
| SECONDARY Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab) |
-1.23; -3.24 | <0.000001 sig |
| SECONDARY Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab) |
19.6; 45.4 | <0.000001 sig |
| SECONDARY Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 (Placebo and Mirikizumab) |
2.0; 15.9 | <0.000001 sig |
| SECONDARY Percentage of Adult Participants Achieving Clinical Response at Week 12 and Corticosteroid-free Clinical Remission at Week 52 (Placebo and Mirikizumab) |
18.6; 43.7 | <0.000001 sig |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Week 52 in Adult Participants (Placebo and Mirikizumab) |
-0.08; -0.93 | <0.000001 sig |
| SECONDARY Change From Baseline in Fecal Calprotectin at Week 52 in Adult Participants (Placebo and Mirikizumab) |
-0.19; -1.41 | <0.000001 sig |
| SECONDARY Percentage of Adult Participants Achieving Clinical Response at Week 12 and Resolution of Baseline Extraintestinal Manifestations (EIMs) at Week 52 (Placebo and Mirikizumab) |
14.6; 43.2 | <0.0001 sig |
| SECONDARY Percentage of Adult Participants Achieving Clinical Response at Week 12 and ≥50% Reduction in Number of Draining Cutaneous Fistulae at Week 52 in Participants With Draining Cutaneous Fistulae at Baseline (Placebo and Mirikizumab) |
16.7; 21.1 | 0.732715 |
| SECONDARY Change From Baseline in Health Related Quality of Life at Week 52 in Adult Participants: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Placebo and Mirikizumab) |
15.9; 43.82 | <0.000001 sig |
| SECONDARY Adult Population Pharmacokinetics (PopPK): Area Under the Concentration Time Curve (AUC) of Mirikizumab |
1820; 220 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CD for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
- Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
- If female, subject must meet the contraception recommendations
Exclusion Criteria
- Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
- Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
- Have a stoma, ileoanal pouch or ostomy
- Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
- Have ever received any monoclonal antibodies binding IL-23
Data sourced from ClinicalTrials.gov (NCT03926130) 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.