The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).
Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC
* Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.
* Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization
* Are up-to-date on colorectal cancer surveillance per local society guidelines
* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
* Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)
NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)
* Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:
* a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12/23, or IL-23p19), except for
* mirikizumab.
* Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib
* sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod
Exclusion Criteria:
* Have a current diagnosis of
* Crohn's disease
* Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or
* primary sclerosing cholangitis
* Have had or will need bowel resection or intestinal or intra-abdominal surgery
* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
* Have any adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed
Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply
* Have a current or recent acute, active infection
Primary outcome measure(s)
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) — Week 12 The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES).
Clinical remission (mMS) is defined as:
* SF subscore = 0 or 1 and no greater than baseline
* RB subscore = 0
* Centrally read ES = 0 or 1; score of 1 modified to exclude friability
Trial sites (147)
Facility
City
Region
Status
Mayo Clinic in Arizona - Scottsdale
Scottsdale
Arizona
Recruiting
Clinnova Research - Anaheim
Anaheim
California
Recruiting
Om Research LLC
Lancaster
California
Recruiting
Biopharma Informatic, LLC
Los Angeles
California
Recruiting
Peak Gastroenterology Associates
Colorado Springs
Colorado
Recruiting
NeoClinical Research
Hialeah
Florida
Recruiting
Encore Borland-Groover Clinical Research
Jacksonville
Florida
Recruiting
Clinical Research of Osceola
Kissimmee
Florida
Recruiting
Florida Research Institute
Lakewood Rch
Florida
Recruiting
Alliance Medical Research
Lighthouse PT
Florida
Recruiting
Atlantic Medical Research
Margate
Florida
Recruiting
Digestive and Liver Center of Florida
Orlando
Florida
Recruiting
Center for Gastrointestinal Health - Fairview Heights
Belleville
Illinois
Not Yet Recruiting
Northwestern University
Chicago
Illinois
Not Yet Recruiting
Midtown Gastroenterology and Liver Disease
Des Plaines
Illinois
Recruiting
GI Alliance - Glenview
Glenview
Illinois
Recruiting
Gi Alliance - Gurnee
Gurnee
Illinois
Recruiting
Gastroenterology Health Partners
New Albany
Indiana
Recruiting
Gastroenterology Health Partners
Louisville
Kentucky
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Recruiting
Clinical Research Institute of Michigan, LLC
Clinton Township
Michigan
Recruiting
GI Associates - GIA and Endoscopy Center - Flowood
Flowood
Mississippi
Recruiting
Digestive Disease Medicine of Central New York
Utica
New York
Recruiting
Dayton Gastroenterology, LLC
Dayton
Ohio
Recruiting
University Gastroenterology - Providence - West River Street
Providence
Rhode Island
Recruiting
Gastroenterology Associates, P.A. of Greenville
Greenville
South Carolina
Recruiting
Gastro One - Walnut Run Road
Cordova
Tennessee
Recruiting
Texas Digestive Disease Consultants - Cedar Park
Cedar Park
Texas
Recruiting
GI Alliance - Dallas - Gaston Avenue
Dallas
Texas
Not Yet Recruiting
GI Alliance - Fort Worth
Fort Worth
Texas
Recruiting
GI Alliance - Garland
Garland
Texas
Recruiting
GI Alliance - Lubbock
Lubbock
Texas
Recruiting
Southern Star Research Institute
San Antonio
Texas
Recruiting
Tyler Research Institute
Tyler
Texas
Recruiting
GI Alliance-Webster
Webster
Texas
Recruiting
Care Access - Ogden
Ogden
Utah
Recruiting
Clinical Research Partners, LLC
Richmond
Virginia
Recruiting
GI Alliance - Richmond
Richmond
Virginia
Recruiting
Carilion Clinic
Roanoke
Virginia
Recruiting
Washington Gastroenterology - Bellevue
Bellevue
Washington
Recruiting
+ 107 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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