Actively Recruiting
Mirikizumab Real World Protocol
Led by University of North Carolina, Chapel Hill · Updated on 2025-07-09
100
Participants Needed
9
Research Sites
242 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to learn about how effective mirikizumab (Omvoh) is when treating patients with ulcerative colitis (UC) Does mirikizumab (Omvoh) lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed mirikizumab (Omvoh) as part of their regular medical care for UC will answer online survey questions about their bowel habits for 1 year.
CONDITIONS
Official Title
Mirikizumab Real World Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with ulcerative colitis
- Started on mirikizumab therapy for moderate to severe ulcerative colitis within 2 weeks prior or plan to start within next 2 weeks
- Mirikizumab treatment must be part of standard-of-care therapy
- Anticipated follow-up by participating center for the next 12 months
- Diagnosis of ulcerative colitis established by standard clinical, radiographic, endoscopic, and histologic criteria
- Symptoms include one or more of diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive
- Symptoms present on two or more occasions at least 8 weeks apart or ongoing symptoms for at least 6 weeks
- Endoscopic findings consistent with ulcerative colitis such as continuous inflammation from rectum without skip lesions
- No signs of Crohn's disease and no inflammation of small intestine except allowed backwash ileitis
You will not qualify if you...
- Unable to provide informed consent
- Non-English speaking
- Presenting for a one-time consultation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
South Denver Gastroenterology
Denver, Colorado, United States, 80113
Actively Recruiting
2
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
3
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States, 40202
Actively Recruiting
5
University Of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
6
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
7
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
8
Southern Star Research Institute, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
9
TIDHI Innovation Inc.
Toronto, Ontario, Canada, M6A3B4
Actively Recruiting
Research Team
E
Emily English, MSW, CCRC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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