INSIGHT-IBD Pragmatic Study
Public ClinicalTrials.gov record NCT07686757. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07686757
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
- Mirikizumab Drug
- Anti-TNF agents Drug
- anti-integrin antibodies Drug
- IL-12 Drug
- IL-23 Drug
Drug
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 12, 2026 (Actual)
- Primary completion
- Jun 2028 (Estimated)
- Completion
- Jun 2028 (Estimated)
- Last update posted
- Oct 2, 2026
2026 – 2028
United States locations
- U.S. sites
- 11
- U.S. states
- 5
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Digestive Health | Sun City | Arizona | 85351 | — |
| GI Alliance of Illinois | Glenview | Illinois | 60005 | — |
| Lake Shore Gastro-Gurnee Research | Gurnee | Illinois | 60031 | — |
| Gastroenterology Group of Rochester | Rochester | New York | 14618 | — |
| Texas Digestive Disease Consultants | Cedar Park | Texas | 78613 | — |
| Texas Digestive Disease Consultants | Fort Worth | Texas | 76104 | — |
| Digestive Health Associates | Houston | Texas | 77024 | — |
| Texas Digestive Disease Consultants: Plano | Plano | Texas | 75093 | — |
| Texas Digestive Disease Consultants: San Antonio | San Antonio | Texas | 78215 | — |
| Texas Digestive Disease Consultants: San Marcos | San Marcos | Texas | 78666 | — |
| GI Alliance Richmond | Richmond | Virginia | 23229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07686757, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07686757 live on ClinicalTrials.gov.