INSIGHT-IBD Pragmatic Study

INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab

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 Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease (CD); Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: Mirikizumab; Drug: Anti-TNF agents; Drug: anti-integrin antibodies; Drug: IL-12; Drug: IL-23

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lorraine O'Donnell; Phone Number: 914-388-4907; Email: lorraine.odonnell@cardinalhealth.com
• Study Contact Backup: Name: Jessica Manzyuk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mirikizumab Clinical Care Pathway; 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.	Drug: Mirikizumab; Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.
Active Comparator: Standard Biologic Therapy Clinical Care Pathway; 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.	Drug: Anti-TNF agents; Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.; Drug: anti-integrin antibodies; Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.; Drug: IL-12; Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.; Drug: IL-23; Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Requiring an Increase in IBD Disease Management	The proportion of patients requiring an increase in inflammatory bowel disease (IBD) disease management, defined as a composite of treatment and healthcare resource use, while receiving index therapy.	Up to 18 months following initiation of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disease Activity Measured by Crohn's Disease PRO2 Scores	Change from baseline in disease activity assessed using validated patient-reported outcome measures: Crohn's Disease Patient-Reported Outcome 2 (CD PRO2), composed of: Abdominal pain score (range 0-3) Stool frequency (number of bowel movements per day; higher values indicate worse disease activity) Changes in PRO2 component scores and composite disease activity will be evaluated over time, with decreases from baseline indicating improvement in disease activity.	Baseline, 6 months, 12 months, and 18 months
Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores	Change from baseline in disease activity assessed using validated patient-reported outcome measures: Ulcerative Colitis Patient-Reported Outcome 2 (UC PRO2), composed of: Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Total possible combined score range: 0-6, with higher scores indicating worse disease activity Changes in PRO2 component scores and composite disease activity will be evaluated over time, with decreases from baseline indicating improvement in disease activity.	Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD)	Proportion of participants achieving endoscopic remission assessed using validated endoscopic scoring system: Simple Endoscopic Score for Crohn's Disease (SES-CD) (range 0-56), where lower scores indicate less endoscopic disease activity and endoscopic remission is defined as a score ≤2 Endoscopic findings are collected as part of routine clinical care, when available.	Up to 18 months (as available from routine clinical care)
Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score.	Proportion of participants achieving endoscopic remission assessed using validated endoscopic scoring systems: Modified Baron Score (ulcerative colitis) (range 0-4), where lower scores indicate less mucosal inflammation and endoscopic remission is defined as a score of 0 (normal mucosa with no visible inflammation) Endoscopic findings are collected as part of routine clinical care, when available.	Up to 18 months (as available from routine clinical care)
Treatment Persistence	Duration of time from treatment initiation to discontinuation of index therapy for any reason, including continued use at pre-specified timepoints.	Up to 18 months
Proportion of Patients with Dose Escalation	Proportion of patients who discontinue index therapy and/or initiate a subsequent IBD therapy during the study period.	Up to 18 months
Time to Next Treatment	Time from initiation of index therapy to initiation of a subsequent therapy or discontinuation of index therapy.	Up to 18 months
Concomitant Medication Use	Proportion of patients receiving concomitant corticosteroids, immunomodulators, or aminosalicylates at baseline and during follow-up, including initiation and discontinuation patterns.	Baseline through 18 months
Corticosteroid-Free Time	Duration of time patients remain free from corticosteroid use while receiving index therapy.	Up to 18 months
Healthcare Resource Utilization	Frequency and rate of IBD-related healthcare utilization	Up to 18 months
Change in Patient-Reported Outcomes Measured by SIBDQ	Change from baseline in patient-reported outcomes assessed using validated instrument: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (range 10-70), where higher scores indicate better health-related quality of life Changes in scores over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.	Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by UNRS	Change from baseline in patient-reported outcomes assessed using validated instrument: Bowel Urgency Numeric Rating Scale (UNRS) (range 0-10), where higher scores indicate worse bowel urgency Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.	Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by PROMIS Global Health	Change from baseline in patient-reported outcomes assessed using validated instrument: PROMIS Global Health (PROMIS-GH) (T-score standardized, mean 50), where higher scores indicate better overall health status Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.	Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by SAA	Change from baseline in patient-reported outcomes assessed using validated instrument: Sexual Activity Avoidance (SAA), where higher scores indicate greater avoidance of sexual activity Changes in scores over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.	Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by WPAI:SHP	Change from baseline in patient-reported outcomes assessed using validated instrumens: Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) (0-100%), where higher percentages indicate greater impairment Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.	Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Clinical Remission Based on Ulcerative Colitis PRO2.	Proportion of participants achieving clinical remission based on validated patient-reported outcome measures: Ulcerative Colitis Patient-Reported Outcome 2 (UC PRO2), composed of: Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Lower scores indicate less disease activity; clinical remission is defined as rectal bleeding score = 0 and stool frequency score ≤1 These thresholds represent minimal or no symptoms consistent with clinical remission.	Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Clinical Remission Based on Crohn's Disease PRO2.	Proportion of participants achieving clinical remission based on validated patient-reported outcome measures: Crohn's Disease Patient-Reported Outcome 2 (UC PRO2), composed of: Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Lower scores indicate less disease activity; clinical remission is defined as rectal bleeding score = 0 and stool frequency score ≤1 These thresholds represent minimal or no symptoms consistent with clinical remission.	Baseline, 6 months, 12 months, and 18 months

Collaborators and Investigators

• Sponsor: Specialty Networks Research.
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Casey Chapman, MD, GIA; Principal Investigator: Nicholas Lazarou, MPH, MBA, Cardinal Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Intercellular Signaling Peptides and Proteins; Cytokines; Interleukins; Interleukin-12; Interleukin-23; mirikizumab
• Other Study ID Numbers: 103899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study does not plan to share Individual Participant Data (IPD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No