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Enrolling by invitationPhase 4

Mirikizumab compared with standard biologic treatment in ulcerative colitis and Crohn's disease

Compares mirikizumab with standard biologics in adults with ulcerative colitis or Crohn's disease.

Key facts

Who runs it
Specialty Networks Research.
Where
Cedar Park, Fort Worth, Glenview, Gurnee, Houston, Indianapolis, Plano, Richmond, Rochester, San Antonio, San Marcos, Sun City, and Tucson, United StatesSee the 13 sites
Trial code
Registry title
INSIGHT-IBD Pragmatic Study
Status
Enrolling by invitation
Phase
Phase 4
People taking part
400 people, planned
Started
12 Aug 2026
Expected to end
Jun 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Mirikizumab
  • Anti-TNF agents
  • anti-integrin antibodies
  • IL-12
  • IL-23
Record updated
29 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with ulcerative colitis or Crohn's disease who are treated in community gastroenterology practices and can start a biologic therapy. They get mirikizumab or standard biologic therapy as part of routine care.

Age
21 years or older
Sex
All sexes can join.
Disease stage
Confirmed ulcerative colitis (UC) or Crohn's disease (CD), and the person can start a biologic therapy for IBD under the IBD Clinical Care Pathway.
Earlier treatment
No earlier treatment with mirikizumab, and no reason why mirikizumab cannot be used. No earlier IL-23p19 blocker (for example mirikizumab, risankizumab, guselkumab). No earlier small molecule IBD therapy (for example JAK inhibitors or S1P receptor modulators).

Main reasons for not taking part

  • Earlier treatment with an IL-23p19 blocker such as mirikizumab, risankizumab or guselkumab
  • Earlier treatment with a JAK inhibitor or S1P receptor modulator for IBD
  • Took part in an interventional clinical trial in the 90 days before enrollment
  • Large bowel surgery: total proctocolectomy (for UC) or removal of two or more intestinal segments (for CD)
  • Any condition that, in the investigator's judgment, may risk safety or the study data

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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, as per the IBD Clinical Care Pathway
  • 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

Who cannot take part

  • 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
  • Surgical removal of two or more intestinal segments (for CD)
  • History of extensive colorectal resection, including:
  • Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study
  • Total proctocolectomy (for UC), or

Where in United States

  • Texas Digestive Disease ConsultantsCedar Park, United StatesEnrolling by invitation
  • Texas Digestive Disease ConsultantsFort Worth, United StatesEnrolling by invitation
  • GI Alliance of IllinoisGlenview, United StatesEnrolling by invitation
  • Lake Shore Gastro-Gurnee ResearchGurnee, United StatesEnrolling by invitation
  • Digestive Health AssociatesHouston, United StatesEnrolling by invitation
  • Indianapolis Gastroenterology & HepatologyIndianapolis, United StatesEnrolling by invitation
  • Texas Digestive Disease Consultants: PlanoPlano, United StatesEnrolling by invitation
  • GI Alliance RichmondRichmond, United StatesEnrolling by invitation
  • Gastroenterology Group of RochesterRochester, United StatesEnrolling by invitation
  • Texas Digestive Disease Consultants: San AntonioSan Antonio, United StatesEnrolling by invitation
  • Texas Digestive Disease Consultants - San MarcosSan Marcos, United StatesEnrolling by invitation
  • Arizona Digestive HealthSun City, United StatesEnrolling by invitation
  • AZ Digestive Health-TucsonTucson, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Mirikizumab Clinical Care PathwayExisting treatment, for comparison

    Participants receive mirikizumab as part of the IBD Clinical Care Pathway in routine clinical practice. Dosing and administration follow the approved prescribing information for ulcerative colitis or Crohn's disease, with treatment and monitoring per standard of care.

    Treatment: Mirikizumab

  • Standard Biologic Therapy Clinical Care PathwayExisting treatment, for comparison

    Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.

    Treatment: Anti-TNF agents, anti-integrin antibodies, IL-12, and IL-23

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab
Plain-language title
Mirikizumab compared with standard biologic treatment in ulcerative colitis and Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 October 2026