RECRUITINGPhase 2INTERVENTIONAL
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 and RB ≥1, with endoscopy performed within 21 days before baseline
- 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
Who Should NOT Join This Trial:
- Have a current diagnosis of
- Crohn's disease
- Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 and RB ≥1, with endoscopy performed within 21 days before baseline
* 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
Treatments Being Tested
DRUG
LY4268989
Administered PO
DRUG
Mirikizumab
Administered IV then SC
DRUG
LY4268989 Placebo
Administered PO
Locations (20)
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States
Clinnova Research - Anaheim
Anaheim, California, United States
Om Research LLC
Lancaster, California, United States
Biopharma Informatic, LLC
Los Angeles, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
NeoClinical Research
Hialeah, Florida, United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, United States
Clinical Research of Osceola
Kissimmee, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Alliance Medical Research
Lighthouse PT, Florida, United States
Atlantic Medical Research
Margate, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Center for Gastrointestinal Health - Fairview Heights
Belleville, Illinois, United States
Midtown Gastroenterology and Liver Disease
Des Plaines, Illinois, United States
GI Alliance - Glenview
Glenview, Illinois, United States
Gi Alliance - Gurnee
Gurnee, Illinois, United States
Gastroenterology Health Partners
New Albany, Indiana, United States
Gastroenterology Health Partners
Louisville, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, United States