Ulcerative Colitis
Conditions
Keywords
Inflammatory Bowel Disease
Brief summary
This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.
Interventions
DRUGMirikizumab
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria * Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug. * Female participants must agree to contraception requirements. *
Exclusion criteria
* Participants must not have developed a new condition, including cancer in the originator study. * Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study * Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study. * Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Clinical Remission | Week 52 | Clinical remission based on the modified Mayo Score (MMS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Endoscopic Remission | Week 52 | Endoscopic remission based on the MMS Endoscopic Subscore (ES). |
| Percentage of Participants in Corticosteroid-free Remission | Week 52 | Participants in corticosteroid-free remission. |
| Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52 | Week 52 | Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index. |
| Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score | Baseline to Week 52 | Health Related Quality of Life based on IBDQ score. |
| UC Symptoms: Numeric Rating Score | Week 160 | UC symptoms based on numeric rating score. |
| Percentage of Participants Who are Hospitalized Due to UC | Baseline to Week 160 | Participants who are hospitalized due to UC. |
| Percentage of Participants Who Undergo UC Surgeries Including Colectomy | Baseline to Week 160 | Participants who undergo UC surgeries including colectomy. |
Countries
Argentina, Australia, Austria, Belgium, Canada, China, Czechia, Denmark, France, Georgia, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Moldova, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed