INSIGHT-IBD Pragmatic Study

2 min read Aug 4, 2026, 2:11 PM

Research and clinical trials Mirikizumab Anti-TNF Anti Integrin IL-23 inhibitor Phase 3 clinical trial Adult patients Clinicians

Why This Matters

The study tests mirikizumab in routine clinical practice against standard biologic therapies to see if it lowers healthcare needs and improves symptoms and quality of life for people with Crohn’s disease or ulcerative colitis.

Who Should Pay Attention

Adults with UC or Crohn’s disease, clinicians prescribing biologics in community GI practices, and researchers studying real-world comparative effectiveness of IBD biologics.

Study Snapshot

Story typeClinical Reference

Trial phasePhase 4

Enrollment400 participants

Study statusNot_yet_recruiting

Source depthTrial registry record

What To Know

This is a real-world, non-randomized interventional registry enrolling adults (≥21) with Crohn’s disease or ulcerative colitis who are eligible for biologic therapy but have not received mirikizumab.

Participants will receive mirikizumab per its approved dosing as part of a clinical care pathway or will receive standard biologic therapy chosen by their clinician. Data collection includes EHR-derived clinical data, routine labs, healthcare utilization, and patient-reported outcome questionnaires with follow-up through about 18 months.

The study excludes people with prior exposure to IL-23p19 antagonists or certain small-molecule IBD therapies and those with extensive colorectal resections. It is listed as Phase 4 and not yet recruiting at multiple community gastroenterology sites in the US.

Keep In Mind

This is a Phase 4 pragmatic interventional trial record (not yet recruiting) describing planned enrollment, eligibility, and outcomes; it does not present results. The registry entry limits enrollment to patients without prior IL-23p19 exposure and excludes prior use of some small-molecule therapies.

Source Details

Review the original publication for the complete reporting, methods, and context.

Read Original Source

Clinical trial Evidence type derived from source or registry metadata.

PublicationClinicalTrials.gov

SponsorSpecialty Networks Research.

Trial IDNCT07686757

Study typeInterventional

Trial phasePhase 4

Enrollment400 participants

Indexed viaClinicalTrials.gov

Source typeTrial registry record

PublishedAug 4, 2026, 12:00 AM

Content availableTrial registry record

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