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INSIGHT-IBD Pragmatic Study

28 augusti 2026 uppdaterad av: Specialty Networks Research.

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

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

400

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arizona
      • Sun City, Arizona, Förenta staterna, 85351
        • Arizona Digestive Health
    • Illinois
      • Glenview, Illinois, Förenta staterna, 60005
        • GI Alliance of Illinois
      • Gurnee, Illinois, Förenta staterna, 60031
        • Lake Shore Gastro-Gurnee Research
    • New York
      • Rochester, New York, Förenta staterna, 14618
        • Gastroenterology Group of Rochester
    • Texas
      • Cedar Park, Texas, Förenta staterna, 78613
        • Texas Digestive Disease Consultants
      • Fort Worth, Texas, Förenta staterna, 76104
        • Texas Digestive Disease Consultants
      • Houston, Texas, Förenta staterna, 77024
        • Digestive Health Associates
      • Plano, Texas, Förenta staterna, 75093
        • Texas Digestive Disease Consultants: Plano
      • San Antonio, Texas, Förenta staterna, 78215
        • Texas Digestive Disease Consultants: San Antonio
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23229
        • GI Alliance Richmond

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Läkemedel: Mirikizumab
Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.
Aktiv komparator: 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.
Läkemedel: Anti-TNF agents
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Läkemedel: anti-integrin antibodies
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Läkemedel: IL-12
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Läkemedel: IL-23
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of Patients Requiring an Increase in IBD Disease Management
Tidsram: Up to 18 months following initiation of therapy
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Disease Activity Measured by Crohn's Disease PRO2 Scores
Tidsram: Baseline, 6 months, 12 months, and 18 months

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
Tidsram: Baseline, 6 months, 12 months, and 18 months

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)
Tidsram: Up to 18 months (as available from routine clinical care)

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.
Tidsram: Up to 18 months (as available from routine clinical care)

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
Tidsram: Up to 18 months
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
Tidsram: Up to 18 months
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
Tidsram: Up to 18 months
Time from initiation of index therapy to initiation of a subsequent therapy or discontinuation of index therapy.
Up to 18 months
Concomitant Medication Use
Tidsram: Baseline through 18 months
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
Tidsram: Up to 18 months
Duration of time patients remain free from corticosteroid use while receiving index therapy.
Up to 18 months
Healthcare Resource Utilization
Tidsram: Up to 18 months
Frequency and rate of IBD-related healthcare utilization
Up to 18 months
Change in Patient-Reported Outcomes Measured by SIBDQ
Tidsram: Baseline, 6 months, 12 months, and 18 months

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
Tidsram: Baseline, 6 months, 12 months, and 18 months

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
Tidsram: Baseline, 6 months, 12 months, and 18 months

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
Tidsram: Baseline, 6 months, 12 months, and 18 months

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
Tidsram: Baseline, 6 months, 12 months, and 18 months

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.
Tidsram: Baseline, 6 months, 12 months, and 18 months

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.
Tidsram: Baseline, 6 months, 12 months, and 18 months
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Specialty Networks Research.

Samarbetspartners

Eli Lilly and Company

Utredare

  • Huvudutredare: Casey Chapman, MD, GIA
  • Huvudutredare: Nicholas Lazarou, MPH, MBA, Cardinal Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 augusti 2026

Primärt slutförande (Beräknad)

1 juni 2028

Avslutad studie (Beräknad)

1 juni 2028

Studieregistreringsdatum

Först inskickad

18 juni 2026

Först inskickad som uppfyllde QC-kriterierna

29 juni 2026

Första postat (Faktisk)

7 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 103899

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

This study does not plan to share Individual Participant Data (IPD)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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