AzTrials
AzTrials

Ulcerative ColitisMIRRORNCT06696014

Mirikizumab Real World Protocol

An observational study of Ulcerative Colitis, run by University of North Carolina, Chapel Hill at 9 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
How many people
6 participants
Where
9 sitesin 2 countries
Study dates
8 May 2025to 8 Jul 2026
How long will I take part?
52 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
  • Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive.
  • AND
Show all 13Show fewer
  • Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration.
  • AND
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States8 sites

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • South Denver Gastroenterology

    Denver, Colorado, 80113

  • University of Iowa Health Care

    Iowa City, Iowa, 52242

  • University of Louisville, Clinical Trials Unit

    Louisville, Kentucky, 40202

  • AdventHealth

    Orlando, Florida, 32804

  • University Of Rochester Medical Center

    Rochester, New York, 14642

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

Other trials in United States

Canada1 site

  • TIDHI Innovation Inc.

    Toronto, Ontario, M6A3B4

Other trials in Canada

About this study

Official title: 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.

Keywords
mirikizumab, Omvoh, MIRROR
Medical subject headings
Colitis, Ulcerative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. induction of clinical response as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.

    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.

    Measured: Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy (each time point will be assessed separately)

Secondary outcomes (7)

  1. 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)

    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.

    Measured: Weeks 0, 12, 24, and 52.

  2. Remission as measured by PROMIS-Anxiety Score

    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.

    Measured: Weeks 0, 12, 24, and 52

  3. Remission as measured by PROMIS-Sleep Score

    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.

    Measured: Weeks 0, 12, 24, and 52

  4. Remission as measured by PROMIS-Social Satisfaction Score

    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.

    Measured: Weeks 0, 12, 24, and 52

  5. Remission as measured by Likert scale urgency Score

    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.

    Measured: Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy

  6. Remission as measured by Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale Score

    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.

    Measured: Baseline (Week 0), Weeks 12, 24, and 52

  7. Remission as measured by The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score

    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).

    Measured: Weeks 0,4,8,12,18,24,36 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start8 May 2025
  3. Primary completion8 Jul 2026
  4. Study completion8 Jul 2026

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6 participants (actual)
Target duration
52 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06696014
Sponsor's protocol ID
24-2191
Acronym
MIRROR
Status last verified
Sep 2026
First submitted
11 Nov 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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 \[UNC\].

Publications

  • Dubinsky M, Bleakman AP, Panaccione R, Hibi T, Schreiber S, Rubin D, Dignass A, Redondo I, Gibble TH, Kayhan C, Travis S. Bowel Urgency in Ulcerative Colitis: Current Perspectives and Future Directions. Am J Gastroenterol. 2023 Nov 1;118(11):1940-1953. doi: 10.14309/ajg.0000000000002404. Epub 2023 Jun 12.

    PubMed 37436151

  • Singh S, Ananthakrishnan AN, Nguyen NH, Cohen BL, Velayos FS, Weiss JM, Sultan S, Siddique SM, Adler J, Chachu KA; AGA Clinical Guidelines Committee. Electronic address: clinicalpractice@gastro.org. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007.

    PubMed 36822736

  • Higgins PD, Schwartz M, Mapili J, Krokos I, Leung J, Zimmermann EM. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut. 2005 Jun;54(6):782-8. doi: 10.1136/gut.2004.056358.

    PubMed 15888785

  • Barnes EL, Hanson JS, Regueiro MD, Saha S, Sands BE, Rubin DT, Dubinsky MC, Siegel CA, Gazis DR, Crawford JM, Long MD. Older Adult Patients Use More Aminosalicylate Monotherapy Compared With Younger Patients With Inflammatory Bowel Disease: TARGET-IBD. J Clin Gastroenterol. 2022 Jul 1;56(6):529-535. doi: 10.1097/MCG.0000000000001557. Epub 2021 Jun 11.

    PubMed 34115661

  • Tinsley A, Macklin EA, Korzenik JR, Sands BE. Validation of the functional assessment of chronic illness therapy-fatigue (FACIT-F) in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1328-36. doi: 10.1111/j.1365-2036.2011.04871.x. Epub 2011 Oct 17.

    PubMed 21999576

  • Dubinsky MC, Clemow DB, Hunter Gibble T, Li X, Vermeire S, Hisamatsu T, Travis SPL. Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. Crohns Colitis 360. 2022 Dec 13;5(1):otac044. doi: 10.1093/crocol/otac044. eCollection 2023 Jan.

    PubMed 36777368

  • Outtier A, Gijbels L, Noman M, Verstockt B, Sabino J, Vermeire S, Ferrante M. Screening Failure in a Large Clinical Trial Centre for Inflammatory Bowel Diseases: Rates, Causes, and Outcomes. Inflamm Bowel Dis. 2023 Sep 1;29(9):1440-1445. doi: 10.1093/ibd/izac227.

    PubMed 36350998

  • Bewtra M, Brensinger CM, Tomov VT, Hoang TB, Sokach CE, Siegel CA, Lewis JD. An optimized patient-reported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index. Inflamm Bowel Dis. 2014 Jun;20(6):1070-8. doi: 10.1097/MIB.0000000000000053.

    PubMed 24810138

  • Long MD, Afzali A, Fischer M, Hudesman D, Abdalla M, McCabe R, Cohen BL, Ungaro RC, Harlan W, Hanson J, Konijeti G, Polyak S, Ritter T, Salzberg B, Seminerio J, English E, Zhang X, Sharma PP, Herfarth HH. Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting. Inflamm Bowel Dis. 2023 Apr 3;29(4):570-578. doi: 10.1093/ibd/izac121.

    PubMed 35700276

  • Ha C, Ullman TA, Siegel CA, Kornbluth A. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol. 2012 Sep;10(9):1002-7; quiz e78. doi: 10.1016/j.cgh.2012.02.004. Epub 2012 Feb 15.

    PubMed 22343692

  • Dulai PS, Singh S, Jairath V, Wong E, Narula N. Integrating Evidence to Guide Use of Biologics and Small Molecules for Inflammatory Bowel Diseases. Gastroenterology. 2024 Mar;166(3):396-408.e2. doi: 10.1053/j.gastro.2023.10.033. Epub 2023 Nov 8.

    PubMed 37949249

  • Lichtenstein GR, Yan S, Bala M, Hanauer S. Remission in patients with Crohn's disease is associated with improvement in employment and quality of life and a decrease in hospitalizations and surgeries. Am J Gastroenterol. 2004 Jan;99(1):91-6. doi: 10.1046/j.1572-0241.2003.04010.x.

    PubMed 14687148

  • Ananthakrishnan AN, Weber LR, Knox JF, Skaros S, Emmons J, Lundeen S, Issa M, Otterson MF, Binion DG. Permanent work disability in Crohn's disease. Am J Gastroenterol. 2008 Jan;103(1):154-61. doi: 10.1111/j.1572-0241.2007.01561.x. Epub 2007 Dec 11.

    PubMed 18076736

  • Shivashankar R, Tremaine WJ, Harmsen WS, Loftus EV Jr. Incidence and Prevalence of Crohn's Disease and Ulcerative Colitis in Olmsted County, Minnesota From 1970 Through 2010. Clin Gastroenterol Hepatol. 2017 Jun;15(6):857-863. doi: 10.1016/j.cgh.2016.10.039. Epub 2016 Nov 14.

    PubMed 27856364

  • Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996-2002. Am J Gastroenterol. 2008 Aug;103(8):1998-2006. doi: 10.1111/j.1572-0241.2008.01960.x.

    PubMed 18796097

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by University of North Carolina, Chapel Hill at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Poor accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06696014, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in