A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Afimkibart: Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Placebo: Placebo matching IV afimkibart.
Study summary
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Eligibility
Primary outcome measure(s)
- Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score — At Week 12
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity. - Percentage of Participants with Endoscopic Response — At Week 12
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Trial sites (203)
| Facility | City | Region | Status |
|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | Recruiting |
| Sun City Clinical Research | Glendale | Arizona | Recruiting |
| Om Research LLC | Lancaster | California | Recruiting |
| Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education | Newport Beach | California | Recruiting |
| Empire Clinical Research | Pomona | California | Withdrawn |
| Stanford Medicine Outpatient Center | Redwood City | California | Recruiting |
| Clinical Applications Laboratories, Inc. | San Diego | California | Recruiting |
| Amicis Research Center | Santa Clarita | California | Recruiting |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | Recruiting |
| J&A Clinical Research | Doral | Florida | Recruiting |
| Auzmer Research | Lakeland | Florida | Recruiting |
| Galenus Group Inc | Lehigh Acres | Florida | Recruiting |
| Homestead Associates in Research, Inc. | Miami | Florida | Recruiting |
| Allied Biomedical Research Institute, Inc | Miami | Florida | Recruiting |
| Rejuvaline Medical Research | Miami | Florida | Recruiting |
| Miami Beach Clinical Research Center | Miami Beach | Florida | Recruiting |
| Eminat Research Group | Miramar | Florida | Recruiting |
| Digestive and Liver Center of Florida | Orlando | Florida | Recruiting |
| Advanced Medical Research Center | Port Orange | Florida | Recruiting |
| Santos Research Center, CORP | Tampa | Florida | Recruiting |
| Cleveland Clinic Florida | Weston | Florida | Recruiting |
| Morehouse School Of Medicine | Atlanta | Georgia | Recruiting |
| The University of Chicago | Chicago | Illinois | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| Robley Rex VA Medical Center | Louisville | Kentucky | Recruiting |
| One GI: GHP - Gastroenterology Health Partners Louisville | Louisville | Kentucky | Recruiting |
| Baton Rouge General Medical Center | Baton Rouge | Louisiana | Recruiting |
| Louisiana Research Center - GastroIntestinal Associates | Shreveport | Louisiana | Recruiting |
| Mercy Medical Center | Baltimore | Maryland | Recruiting |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | Recruiting |
| University of Massachusetts Memorial Medical Center | North Worcester | Massachusetts | Recruiting |
| Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming | Michigan | Recruiting |
| Gastrointestinal Associates Research | Flowood | Mississippi | Recruiting |
| Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital | Columbia | Missouri | Recruiting |
| Specialists in Gastroenterology | St Louis | Missouri | Recruiting |
| Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center | Lebanon | New Hampshire | Recruiting |
| Virtua Crohns and Colitis Center | Moorestown | New Jersey | Recruiting |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | Recruiting |
| Ellipsis Research Group | Brooklyn | New York | Recruiting |
| Intercity Gastroenterology | Fresh Meadows | New York | Recruiting |
+ 163 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Spain
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 NCT06819891 on ClinicalTrials.gov ↗ ← All trials in Spain