LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Recruiting · NCT07186101 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 19 US states.
- 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
- Northwestern University - Chicago, 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
- GI Associates - GIA and Endoscopy Center - Flowood - Flowood, Mississippi, United States
- Digestive Disease Medicine of Central New York - Utica, New York, United States
- Dayton Gastroenterology, LLC - Dayton, Ohio, United States
- University Gastroenterology - Providence - West River Street - Providence, Rhode Island, United States
- Gastroenterology Associates, P.A. of Greenville - Greenville, South Carolina, United States
- Gastro One - Walnut Run Road - Cordova, Tennessee, United States
- Texas Digestive Disease Consultants - Cedar Park - Cedar Park, Texas, United States
- GI Alliance - Dallas - Gaston Avenue - Dallas, Texas, United States
- GI Alliance - Fort Worth - Fort Worth, Texas, United States
- GI Alliance - Garland - Garland, Texas, United States
- GI Alliance - Lubbock - Lubbock, Texas, United States
- Southern Star Research Institute - San Antonio, Texas, United States
- Tyler Research Institute - Tyler, Texas, United States
- GI Alliance-Webster - Webster, Texas, United States
- Care Access - Ogden - Ogden, Utah, United States
- Clinical Research Partners, LLC - Richmond, Virginia, United States
- GI Alliance - Richmond - Richmond, Virginia, United States
- Carilion Clinic - Roanoke, Virginia, United States
- Washington Gastroenterology - Bellevue - Bellevue, Washington, United States
- Adana City Hospital - Adana, Turkey (Türkiye)
- Sardar Vallabhbhai Patel Institute of Medical Sciences and Research - Ahmedabad, India
- Gazi University Health Research and Application Center Gazi Hospital - Ankara, Turkey (Türkiye)
- Antalya Egitim ve Arastırma Hastanesi - Antalya, Turkey (Türkiye)
- Centro Médico Teknon - Barcelona, Spain
- Charité Universitaetsmedizin Berlin - Campus Mitte - Berlin, Germany
- Chronos Pesquisa Clínica - Brasília, Brazil
- Delta Health Care - Bucharest, Romania
- Spitalul Clinic Colentina - Bucharest, Romania
- Óbudai Egészségügyi Centrum - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Pannónia Magánorvosi Centrum - Budapest, Hungary
- Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház - Békéscsaba, Hungary
- CAEP - Synvia Labs - Campinas, Brazil
- Fundação Universidade de Caxias do Sul (FUCS) - Caxias do Sul, Brazil
- Changzhou Second People's Hospital - Changzhou, China
- Rajiv Gandhi Government General Hospital - Chennai, India
- Scientia Investigacion Clinica S.C. - Chihuahua City, Mexico
- Chongqing General Hospital - Chongqing, China
- Ashwin Hospital - Coimbatore, India
Showing 60 of 147 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →