TrialPath
← Back to searchRecruiting

Mirikizumab Real World Protocol

NCT06696014 · University of North Carolina, Chapel Hill
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry
About this study
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.
Study design
Enrollment target: 100 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-05-08
Estimated completion: 2030-01
Last updated: 2025-07-09
Primary outcomes
  • induction of clinical response as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes. (Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy (each time point will be assessed separately))
Sponsor
University of North Carolina, Chapel Hill · other
With: Eli Lilly and Company
Contacts & investigators
ContactEmily English, MSW, CCRC · contact · emily_english@med.unc.edu · 919-843-8105
InvestigatorHans Herfarth, MD, PhD · principal_investigator, University of North Carolina
All locations (9)
South Denver GastroenterologyRecruiting
Denver, Colorado, United States
AdventHealthRecruiting
Orlando, Florida, United States
University of Iowa Health CareRecruiting
Iowa City, Iowa, United States
University of Louisville, Clinical Trials UnitRecruiting
Louisville, Kentucky, United States
University Of Rochester Medical CenterRecruiting
Rochester, New York, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
Medical University of South Carolina (MUSC)Recruiting
Charleston, South Carolina, United States
Southern Star Research Institute, LLCRecruiting
San Antonio, Texas, United States
TIDHI Innovation Inc.Recruiting
Toronto, Ontario, Canada
Mirikizumab Real World Protocol · TrialPath