A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Recruiting · NCT07483073 · 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
Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.
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
- 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.
Exclusion criteria
- 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
Where it is running
60 locations listed across 11 US states.
- Mayo Clinic in Arizona - Scottsdale - Scottsdale, Arizona, United States
- Mayo Clinic in Arizona - Scottsdale - Scottsdale, Arizona, United States
- Biopharma Informatic, LLC - Los Angeles, California, United States
- Biopharma Informatic, LLC - Los Angeles, California, United States
- Om Research LLC - Oxnard, California, United States
- Om Research LLC - Oxnard, California, United States
- South Denver Gastroenterology - Englewood, Colorado, United States
- South Denver Gastroenterology - Englewood, Colorado, United States
- Gastro Health Research - Miami - Miami, Florida, United States
- Gastro Health Research - Miami - Miami, Florida, United States
- Ezy Medical Research - Miami Lakes, Florida, United States
- Ezy Medical Research - Miami Lakes, Florida, United States
- Atlanta Gastroenterology Associates - Peachtree Dunwoody - Atlanta, Georgia, United States
- Atlanta Gastroenterology Associates - Peachtree Dunwoody - Atlanta, Georgia, United States
- Rush University Medical Center - Chicago, Illinois, United States
- Rush University Medical Center - Chicago, Illinois, United States
- Cotton O'Neil Digestive Health Center - Topeka, Kansas, United States
- Cotton O'Neil Digestive Health Center - Topeka, Kansas, United States
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center - Wyoming, Michigan, United States
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center - Wyoming, Michigan, United States
- KAD Clinical Research - St Louis, Missouri, United States
- KAD Clinical Research - St Louis, Missouri, United States
- Vector Clinical Trials - Las Vegas, Nevada, United States
- Vector Clinical Trials - Las Vegas, Nevada, United States
- One of a Kind Clinical Research Center - Kingwood - Kingwood, Texas, United States
- One of a Kind Clinical Research Center - Kingwood - Kingwood, Texas, United States
- Southern Star Research Institute - San Antonio, Texas, United States
- Southern Star Research Institute - San Antonio, Texas, United States
- Assuta Ashdod Medical Center - Ashdod, Israel
- Assuta Ashdod Medical Center - Ashdod, Israel
- Charité Universitaetsmedizin Berlin - Campus Mitte - Berlin, Germany
- Charité Universitaetsmedizin Berlin - Campus Mitte - Berlin, Germany
- Geomedical Egészségügyi Központ - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Geomedical Egészségügyi Központ - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Loema Instituto de Pesquisa Clinica - Campinas, Brazil
- Loema Instituto de Pesquisa Clinica - Campinas, Brazil
- Fundação Universidade de Caxias do Sul (FUCS) - Caxias do Sul, Brazil
- Fundação Universidade de Caxias do Sul (FUCS) - Caxias do Sul, Brazil
- The Second Xiangya Hospital of Central South University - Changsha, China
- The Second Xiangya Hospital of Central South University - Changsha, China
- Changzhou Second People's Hospital - Changzhou, China
- Changzhou Second People's Hospital - Changzhou, China
- Centro Digestivo de Curitiba - Curitiba, Brazil
- Centro Digestivo de Curitiba - Curitiba, Brazil
- Studienzentrum MVZ Dachau - Dachau, Germany
- Studienzentrum MVZ Dachau - Dachau, Germany
- Azienda Ospedaliera Universitaria Careggi - Florence, Italy
- Azienda Ospedaliera Universitaria Careggi - Florence, Italy
- AZ Maria Middelares - Ghent, Belgium
- UZ Gent - Ghent, Belgium
- AZ Maria Middelares - Ghent, Belgium
- UZ Gent - Ghent, Belgium
- The First Affiliated Hospital, Sun Yat-sen University - Guangzhou, China
- The First Affiliated Hospital, Sun Yat-sen University - Guangzhou, China
- Rambam Health Care Campus - Haifa, Israel
- Rambam Health Care Campus - Haifa, Israel
- Studiengesellschaft Mitteldeutschland GmbH - Halle, Germany
- Studiengesellschaft Mitteldeutschland GmbH - Halle, Germany
Showing 60 of 140 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →