Last updated 16 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, Spain
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
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
Rocco & Nazato Serviços Médicos Ltda (Clínica Hepatogastro JK)
Instituto CHRONOS de Apoio à Pesquisa (ICAPE)
FAICIC Clinical Research
Instituto Nacional de Ciencias Médicas y Nutrición Dr. Salvador Zubirán
Centro de Investigación Clínica Chapultepec - Sanatorio La Luz
StudyTOPAZ-UC
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Moderate/severe ulcerative colitis
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07186101
