Last updated 6 days ago
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
60 patients around the world
Available in United States, Brazil
Eli Lilly and Company
8Research sites
60Patients around the world
This study is for people with
Ulcerative colitis
Crohn's disease
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.For UC.Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.For CD.Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization.Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD.Have screening laboratory test results within the protocol specified parameters.
- Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis.For UC - must not have a current diagnosis of CD.For CD - must not have a current diagnosis of UC.Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol.Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome.Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data.Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action.Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment.Must not have received or will need any prohibited medications for UC or CD as specified in the protocol.
Sites
Loema - Instituto de Pesquisa Clinica e Consultores
Fundação Universidade de Caxias do Sul
Centro de Diabetes Curitiba - Curitiba, Parana
CPQuali Pesquisa Clínica
CPClin – Centro de Pesquisas Clinicas LTDA
BR Trials - Pesquisa Clínica - Sao Paulo
Clínica Hepatogastro JK
Cedoes - Pesquisa e Diagnóstico
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Ulcerative colitisCrohn's disease
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07483073
