Mirikizumab Real World Protocol

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06696014
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 8, 2025
Status verified
Jul 2025
Primary completion
Jan 1, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
100 participants (estimated)

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) ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
South Denver GastroenterologyDenverColorado80113
Samantha Reiff
[email protected]
303-406-4288
Marcelo Kugelmas, MD (PRINCIPAL_INVESTIGATOR)
AdventHealthOrlandoFlorida32804
Amber Barrick
[email protected]
407-619-1316
Jennifer Seminerio-Diehl, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Health CareIowa CityIowa52242
Megan Sharer
[email protected]
319-467-4169
Steven Polyak, MD (PRINCIPAL_INVESTIGATOR)
University of Louisville, Clinical Trials UnitLouisvilleKentucky40202
Kimiko Kasama
[email protected]
502-852-7402
Gerald Dryden, M.D., Ph.D., MSPH, M.Sc. (PRINCIPAL_INVESTIGATOR)
University Of Rochester Medical CenterRochesterNew York14642
Munazza Zakirullah
[email protected]
Maisa Abdalla, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Emily English, MSW, CCRC
[email protected]
919-843-8105
Hans Herfarth, MD, PhD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425
Angela Francisco
[email protected]
843-792-3710
Erin Forster, MD, MPH (PRINCIPAL_INVESTIGATOR)
Southern Star Research Institute, LLCSan AntonioTexas78229
Mireya Garza
[email protected]
210-581-2812
Jeff Bullock, MC (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
South Denver Gastroenterology· Denver, COAdventHealth· Orlando, FLUniversity of Iowa Health Care· Iowa City, IAUniversity of Louisville, Clinical Trials Unit· Louisville, KYUniversity Of Rochester Medical Center· Rochester, NYUniversity of North Carolina· Chapel Hill, NC

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