NCT06696014 · University of North Carolina, Chapel Hill
Mirikizumab Real World Protocol
(MIRROR)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on mirikizumab therapy for moderate to severe UC or who plan to begin this therapy within the next 2 weeks. The start of the mirikizumab treatment must have been or be initiated in the setting of standard-of-care therapy.
- Anticipation that the patient will be followed by the participating center for the next 12 months.
- Diagnosis of UC must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below. Criteria for diagnosis of UC The following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with Ulcerative Colitis. A) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive. AND B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration. AND C) Endoscopic Findings compatible with UC:
- Superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon, which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (relative rectal sparing is allowed for patients receiving topical, rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).
- In patients with proctitis or left-sided ulcerative colitis, there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.
- No inflammation of the small intestine ("backwash ileitis" is allowed - non-stenotic superficial inflammation of the terminal ileal mucosa associated with severe pancolitis, which resolves following medical or surgical treatment of the colitis).
- No features of Crohn's disease listed above. There is no minimum length of extension of UC required for inclusion in this study.
Exclusion criteria
- Patients will be excluded if they meet any of the following criteria:
- Inability to provide informed consent.
- Non-English speaking.
- Patients presenting for a one-time consultation.
Where
- Denver, Colorado
- Orlando, Florida
- Iowa City, Iowa
- Louisville, Kentucky
- Rochester, New York
- Chapel Hill, North Carolina
- Charleston, South Carolina
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2025 · Source of record for eligibility and locations