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
Condition(s) studied
Investigational drug(s) / intervention(s)
Afimkibart: Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Placebo: Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Percentage of Participants with Clinical Remission — At Week 12
Percentage of participants achieving Modified Mayo Score (mMS) \<=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
Trial sites (168)
| Facility | City | Region | Status |
|---|---|---|---|
| Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan | Dothan | Alabama | |
| Mayo Clinic Hospital | Scottsdale | Arizona | |
| Arizona Digestive Health, P.C (ADH) | Sun City | Arizona | |
| Om Research LLC | Apple Valley | California | |
| Valley View Internal Medicine | Garden Grove | California | |
| Gastro Care Associates | Lancaster | California | |
| Stanford Medicine Outpatient Center | Redwood City | California | |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | |
| Hi Tech and Global Research, LLC | Coral Gables | Florida | |
| The Sister Life Research | Hialeah | Florida | |
| LCC Medical Research Institute, LLC | Miami | Florida | |
| Allied Biomedical Research Institute | Miami | Florida | |
| Integrity Trials LLC | Orlando | Florida | |
| Digestive and Liver Center of Florida | Orlando | Florida | |
| Advanced Medical Research Center | Port Orange | Florida | |
| University of South Florida School of Medicine Morsani Center for Advanced Health Care | Tampa | Florida | |
| Guardian Angel Research Center, LLC | Tampa | Florida | |
| Santos Research Center, CORP | Tampa | Florida | |
| Cleveland Clinic Florida | Weston | Florida | |
| Randomize Now, LLC | Atlanta | Georgia | |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | |
| Illinois Gastroenterology Group-Glenview powered by GI Alliance | Glenview | Illinois | |
| GI Alliance - Gurnee | Gurnee | Illinois | |
| Gastro Health Partners, LLC | New Albany | Indiana | |
| Kansas Gastroenterology, LLC under Clinical Trials Network | Wichita | Kansas | |
| One GI: GHP - Gastroenterology Health Partners Louisville | Louisville | Kentucky | |
| Louisiana Research Center - GastroIntestinal Associates | Shreveport | Louisiana | |
| Allied Gastrointestinal Associates, PA | Flowood | Mississippi | |
| Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center | Lebanon | New Hampshire | |
| Ellipsis Research Group | Brooklyn | New York | |
| NYU Inflammatory Bowel Disease Center | New York | New York | |
| Weill Cornell Medical College | New York | New York | |
| DiGiovanna Inst for Med Ed&Res | North Massapequa | New York | |
| Queens Village Medical Care | Queens Village | New York | |
| Gastroenterology Group Of Rochester, LLP | Rochester | New York | |
| Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte | North Carolina | |
| Omega Research North Carolina, LLC | Fuquay-Varina | North Carolina | |
| Peters Medical Research (PMR), LLC | High Point | North Carolina | |
| Dayton Gastroenterology, Inc. | Beavercreek | Ohio |
+ 128 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06588855 on ClinicalTrials.gov ↗ ← All trials in Italy