INSIGHT-IBD Pragmatic Study (NCT07686757) | Clinical Trial Compass
Not Yet RecruitingPhase 4
INSIGHT-IBD Pragmatic Study
United States400 participantsStarted 2026-09
Plain-language summary
The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.
The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States.
The main questions it aims to answer are:
* Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)?
* Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy?
* Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization.
Participants will:
* Receive either mirikizumab or standard biologic therapy as part of routine clinical care
* Attend follow-up visits at approximately 3, 6, 12, and 18 months
* Have clinical data collected from electronic health records and healthcare utilization sources
* Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning
* Undergo routine laboratory tests and clinical assessments as part of standard care
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥21 years at the time of enrollment
* Confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD)
* Eligible for treatment with biologic therapy for IBD, defined as failure of prior conventional therapy and/or prior biologic therapy (excluding IL-23p19 antagonists)
* No prior exposure to mirikizumab and no contraindications to mirikizumab
* Ability to provide informed consent
* Willingness to comply with study procedures and follow-up requirements
Exclusion Criteria:
* Prior exposure to IL-23p19 antagonists (e.g., mirikizumab, risankizumab, guselkumab)
* Prior exposure to small molecule targeted therapies for IBD (e.g., JAK inhibitors or S1P receptor modulators)
* Participation in an interventional clinical trial within 90 days prior to enrollment
* History of extensive colorectal resection, including:
* Total proctocolectomy (for UC), or
* Surgical removal of two or more intestinal segments (for CD)
* Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients Requiring an Increase in IBD Disease Management
Timeframe: Up to 18 months following initiation of therapy