Mirikizumab Real World Protocol (MIRROR)

July 8, 2025 updated by: University of North Carolina, Chapel Hill

MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry

The goal of this observational study is to learn about how effective mirikizumab (Omvoh) is when treating patients with ulcerative colitis (UC)

Does mirikizumab (Omvoh) lead to a reduction in symptoms at intervals throughout one year?

Participants being prescribed mirikizumab (Omvoh) as part of their regular medical care for UC will answer online survey questions about their bowel habits for 1 year.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A3B4
        • Recruiting
        • TIDHI Innovation Inc.
        • Principal Investigator:
          • Mark Silverberg, MD, PhD
        • Contact:
  • United States
    • Colorado
      • Denver, Colorado, United States, 80113
        • Recruiting
        • South Denver Gastroenterology
        • Contact:
        • Principal Investigator:
          • Marcelo Kugelmas, MD
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth
        • Contact:
        • Principal Investigator:
          • Jennifer Seminerio-Diehl, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care
        • Contact:
        • Principal Investigator:
          • Steven Polyak, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville, Clinical Trials Unit
        • Contact:
        • Principal Investigator:
          • Gerald Dryden, M.D., Ph.D., MSPH, M.Sc.
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • Maisa Abdalla, MD, MPH
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • Hans Herfarth, MD, PhD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina (MUSC)
        • Contact:
        • Principal Investigator:
          • Erin Forster, MD, MPH
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute, LLC
        • Contact:
        • Principal Investigator:
          • Jeff Bullock, MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with ulcerative colitis starting mirikizumab in the setting of standard-of-care

Description

Inclusion Criteria:

  • Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on mirikizumab therapy for moderate to severe UC or who plan to begin this therapy within the next 2 weeks. The start of the mirikizumab treatment must have been or be initiated in the setting of standard-of-care therapy.
  • Anticipation that the patient will be followed by the participating center for the next 12 months.
  • Diagnosis of UC must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.

Criteria for diagnosis of UC The following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with Ulcerative Colitis.

A) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive.

AND

B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration.

AND

C) Endoscopic Findings compatible with UC:

  • Superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon, which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (relative rectal sparing is allowed for patients receiving topical, rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).
  • In patients with proctitis or left-sided ulcerative colitis, there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.
  • No inflammation of the small intestine ("backwash ileitis" is allowed - non-stenotic superficial inflammation of the terminal ileal mucosa associated with severe pancolitis, which resolves following medical or surgical treatment of the colitis).
  • No features of Crohn's disease listed above. There is no minimum length of extension of UC required for inclusion in this study.

Exclusion Criteria:

Patients will be excluded if they meet any of the following criteria:

  • Inability to provide informed consent.
  • Non-English speaking.
  • Patients presenting for a one-time consultation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction of clinical response as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.
Time Frame: Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy (each time point will be assessed separately)

The SCCAI is a 6-item that describes the symptoms and disease activity of a patient with UC at the time of assessment. A score of 0-4 is considered a clinical range of remission (but with more refined definitions of clinical remission with SCCAI ≤2 and very mild symptoms with a score >2 ≤4), 5-7 mild activity, 8-16 moderate activity and > 16 severe activity.

A response will be defined as a decrease of the SCCAI score < 5 points in patients with a baseline SCCAI ≥5.
Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy (each time point will be assessed separately)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression Scoreoint will be assessed separately) (as measured by various PROs as outlined in methods)
Time Frame: Weeks 0, 12, 24, and 52.
Description: PROMIS measure of depression measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Differences in PROMIS scores compared to baseline will be assessed.
Weeks 0, 12, 24, and 52.
Remission as measured by PROMIS-Anxiety Score
Time Frame: Weeks 0, 12, 24, and 52
PROMIS measure of anxiety measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Differences in PROMIS scores compared to baseline will be assessed.
Weeks 0, 12, 24, and 52
Remission as measured by PROMIS-Sleep Score
Time Frame: Weeks 0, 12, 24, and 52
PROMIS measure of sleep measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Differences in PROMIS scores compared to baseline will be assessed.
Weeks 0, 12, 24, and 52
Remission as measured by PROMIS-Social Satisfaction Score
Time Frame: Weeks 0, 12, 24, and 52
PROMIS measure of satisfaction measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Differences in PROMIS scores compared to baseline will be assessed.
Weeks 0, 12, 24, and 52
Remission as measured by Likert scale urgency Score
Time Frame: Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy
Urgency will be measured by the 11-point Likert scale urgency question as validated in the mirikizumab clinical trials. Score range is 0-10. The higher the score, the worse the urgency.
Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy
Remission as measured by Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale Score
Time Frame: Baseline (Week 0), Weeks 12, 24, and 52
Fatigue will be determined by the validated FACIT-F questionnaire. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Score range is 0-52. The higher the score, the better the quality of life.
Baseline (Week 0), Weeks 12, 24, and 52
Remission as measured by The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
Time Frame: Weeks 0,4,8,12,18,24,36 and 52
The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).
Weeks 0,4,8,12,18,24,36 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Hans Herfarth, MD, PhD, University of North Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-2191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 3 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina [UNC].

IPD Sharing Time Frame

Beginning 3 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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