| NCT ID | NCT06696014 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Ulcerative Colitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-08 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-05-08 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Hans Herfarth, MD, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina
Frequently Asked Questions
Who can join the NCT06696014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06696014 currently recruiting?
Yes, NCT06696014 is actively recruiting participants. Contact the research team at emily_english@med.unc.edu for enrollment information.
Where is the NCT06696014 trial being conducted?
This trial is being conducted at Denver, United States, Orlando, United States, Iowa City, United States, Louisville, United States and 5 additional locations.
Who is sponsoring the NCT06696014 clinical trial?
NCT06696014 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Hans Herfarth, MD, PhD at University of North Carolina. The trial plans to enroll 100 participants.
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