Last updated 4 days ago
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
252 patients around the world
Available in Brazil, United States, Mexico
Eli Lilly and Company
15Research sites
252Patients around the world
This study is for people with
Ulcerative colitis
Moderate/severe ulcerative colitis
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- Have had an established diagnosis of ulcerative colitis (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 Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES) ≥2 confirmed by central reader and rectal bleeding (RB) ≥1, with endoscopy performed within 14 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.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.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.
- Have a current diagnosis of Crohn's disease.Have a current diagnosis of Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis).Have a current diagnosis of 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.Have a current or recent acute, active infection.
Sites
Chronos Clinica Medica Ltda
Fundação Universidade de Caxias do Sul
Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
Hospital Ernesto Dornelles
CPQuali Pesquisa Clínica
Hospital Municipal Vila Santa Catarina
Clínica Hepatogastro JK
FAICIC Clinical Research
Instituto Nacional de Ciencias Médicas y Nutrición Dr. Salvador Zubirán
Centro de Investigación y Gastroenterología - México
StudyTOPAZ-UC
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Moderate/severe ulcerative colitis
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07186101
