Phase 2
N=249
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT02589665 ↗Enrolled (actual)
249
Serious AEs
3.8%
Results posted
May 2020
Primary outcome: Primary: Induction Period: Percentage of Participants With Clinical Remission at Week 12 — 4.8; 15.9; 22.6; 11.5 percentage of participants
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 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction Period: Percentage of Participants With Clinical Remission at Week 12 |
4.8; 15.9; 22.6; 11.5 | — |
| SECONDARY Induction Period: Percentage of Participants With Clinical Response at Week 12 |
20.6; 41.3; 59.7; 49.2 | — |
| SECONDARY Induction Period: Percentage of Participants With Endoscopic Remission at Week 12 |
1.6; 3.2; 3.2; 1.6 | 0.986 |
| SECONDARY Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52 |
7.7; 14.9; 28.3 | — |
| SECONDARY Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score |
22.3; 33.0; 42.8; 45.2 | — |
| SECONDARY Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36) |
3.4; 6.2; 5.9; 6.9; 3.2; 4.5 | — |
| SECONDARY Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score |
-0.84; -1.43; -1.90; -1.74 | — |
| SECONDARY Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12 |
3.37; 2.69; 2.39; 2.53 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab |
3330; 10100; 24900; 3700; 1270 | — |
| SECONDARY Induction Period: Percentage of Participants With Symptomatic Remission at Week 12 |
20.6; 36.5; 58.1; 45.9 | 0.003 sig |
| SECONDARY Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52 |
53.8; 76.6; 65.2 | 0.131 |
| SECONDARY Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12 |
6.3; 23.8; 30.6; 13.1 | 0.215 |
| SECONDARY Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52 |
15.4; 57.4; 47.8 | 0.428 |
Summary
The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.
Eligibility Criteria
Inclusion Criteria
- Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
- Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved colon)
- Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
- Participants must either: be naive to biologic therapy (eg, tumor necrosis factor [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment
Exclusion Criteria
- Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
- Have had surgery for treatment of UC or are likely to require surgery for UC during the study
- Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening
Data sourced from ClinicalTrials.gov (NCT02589665). 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.