RECRUITINGPhase 3INTERVENTIONAL
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
About This Trial
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Who May Be Eligible (Plain English)
Who May Qualify:
- Confirmed diagnosis of UC
- Moderately to severely active UC assessed by mMS
- Bodyweight \>= 40 kilogram (kg)
- Up to date with colorectal cancer (CRC) screening performed according to local standards
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
Who Should NOT Join This Trial:
- Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
- Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
- Presence of an ostomy or ileoanal pouch
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
- History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human weakened immune system virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Confirmed diagnosis of UC
* Moderately to severely active UC assessed by mMS
* Bodyweight \>= 40 kilogram (kg)
* Up to date with colorectal cancer (CRC) screening performed according to local standards
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria:
* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
* Presence of an ostomy or ileoanal pouch
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Treatments Being Tested
DRUG
Afimkibart
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
DRUG
Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Locations (20)
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan, Alabama, United States
Mayo Clinic Hospital
Scottsdale, Arizona, United States
Arizona Digestive Health, P.C (ADH)
Sun City, Arizona, United States
Om Research LLC
Apple Valley, California, United States
Valley View Internal Medicine
Garden Grove, California, United States
Gastro Care Associates
Lancaster, California, United States
University of Southern California
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California, United States
Stanford Medicine Outpatient Center
Redwood City, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, United States
The Sister Life Research
Hialeah, Florida, United States
LCC Medical Research Institute, LLC
Miami, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Ambert Medical Research
Miami, Florida, United States
Integrity Trials LLC
Orlando, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa, Florida, United States
Guardian Angel Research Center, LLC
Tampa, Florida, United States