Phase 2
N=191
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02891226 ↗Enrolled (actual)
191
Serious AEs
8.0%
Results posted
Feb 2022
Primary outcome: Primary: Percentage of Participants Achieving Endoscopic Response at Week 12 — 10.9; 25.8; 37.5; 43.8 percentage of participants — p=0.079
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mirikizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Endoscopic Response at Week 12 |
10.9; 25.8; 37.5; 43.8 | 0.079 |
| SECONDARY Percentage of Participants Achieving Endoscopic Remission at Week 12 |
1.6; 6.5; 15.6; 20.3 | 0.241 |
| SECONDARY Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12 |
6.3; 12.9; 28.1; 21.9 | 0.330 |
| SECONDARY Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12 |
-0.44; -1.08; -1.27; -0.98 | 0.007 sig |
| SECONDARY Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12 |
3.6; 2.8; 2.6; 2.5 | — |
| SECONDARY Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12 |
17.11; 41.16; 46.57; 42.35 | <0.001 sig |
| SECONDARY Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12 |
2.90; 10.81; 9.09; 9.62 | <0.001 sig |
| SECONDARY Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12 |
2.34; 7.47; 6.52; 6.05; 3.11; 4.70 | 0.008 sig |
| SECONDARY Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab |
0.0225 | — |
| SECONDARY Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab |
5.05 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.
Eligibility Criteria
Inclusion Criteria
- Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.
- Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.
Exclusion Criteria
- Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.
- Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.
- Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.
- Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.
Data sourced from ClinicalTrials.gov (NCT02891226). 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.