RecruitingNCT06696014

Mirikizumab Real World Protocol

MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry


Sponsor

University of North Carolina, Chapel Hill

Enrollment

100 participants

Start Date

May 8, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world study is collecting data on how mirikizumab — a newer biologic drug that targets the IL-23 immune pathway — performs in patients with moderate to severe ulcerative colitis (UC) in everyday clinical practice (outside of a controlled clinical trial). The goal is to understand how well it works across a diverse patient population. **You may be eligible if...** - You are 18 or older - You have been diagnosed with ulcerative colitis based on standard clinical, imaging, endoscopic, and tissue criteria - You have recently started mirikizumab (within the past 2 weeks) or are about to start it as a standard-of-care treatment - Your treating center expects to follow you for at least 12 months **You may NOT be eligible if...** - You are not starting mirikizumab as part of your routine care - You do not meet diagnostic criteria for UC - You are unwilling to be followed for the study duration Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(9)

South Denver Gastroenterology

Denver, Colorado, United States

AdventHealth

Orlando, Florida, United States

University of Iowa Health Care

Iowa City, Iowa, United States

University of Louisville, Clinical Trials Unit

Louisville, Kentucky, United States

University Of Rochester Medical Center

Rochester, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

TIDHI Innovation Inc.

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06696014


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