A Study to Assess the Efficacy and Safety of Induction and Maintenance 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. Placebo matching SC afimkibart.
Study summary
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance 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 52
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 52
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 (374)
| Facility | City | Region | Status |
|---|---|---|---|
| Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan | Dothan | Alabama | Recruiting |
| Mayo Clinic Hospital | Phoenix | Arizona | Recruiting |
| Arizona Digestive Health, P.C (ADH) | Sun City | Arizona | Recruiting |
| University of Arizona-CATS Research Center | Tucson | Arizona | Recruiting |
| Valley View Internal Medicine | Garden Grove | California | Recruiting |
| 310 Clinical Research | Inglewood | California | Recruiting |
| UCSD Medical Center | La Jolla | California | Recruiting |
| University of California San Diego | La Jolla | California | Recruiting |
| Gastro Care Associates | Lancaster | California | Recruiting |
| Om Research LLC | Lancaster | California | Recruiting |
| United Gastroenterologists | Los Alamitos | California | Recruiting |
| Acclaim Clinical Research, Inc. | San Diego | California | Recruiting |
| Kaiser Permanente | San Francisco | California | Recruiting |
| UCSF/Medical Center at Mount Zion | San Francisco | California | Recruiting |
| Rocky Mountain Gastroenterology | Littleton | Colorado | Recruiting |
| Peak Gastroenterology Surgery Center | Lone Tree | Colorado | Recruiting |
| Access Research Institute | Brooksville | Florida | Recruiting |
| Gastro Florida | Clearwater | Florida | Recruiting |
| HealthMed Clinical Center Inc. | Coral Gables | Florida | Recruiting |
| Hi Tech and Global Research, LLC | Coral Gables | Florida | Recruiting |
| The Sister Life Research | Hialeah | Florida | Recruiting |
| NeoClinical Research | Hialeah | Florida | Recruiting |
| Clinical Research of Osceola, LLC | Kissimmee | Florida | Recruiting |
| Florida Research Institute - Lakewood | Lakewood Rch | Florida | Recruiting |
| LCC Medical Research Institute, LLC | Miami | Florida | Recruiting |
| Ambert Medical Research | Miami | Florida | Withdrawn |
| Orlando Regional Healthcare | Orlando | Florida | Recruiting |
| Nodal Medical Center Research - NMC | Tampa | Florida | Recruiting |
| University of South Florida School of Medicine Morsani Center for Advanced Health Care | Tampa | Florida | Recruiting |
| Guardian Angel Research Center, LLC | Tampa | Florida | Recruiting |
| Theia Clinical Research Centers, LLC | Temple Terrace | Florida | Recruiting |
| Cleveland Clinic Florida | Weston | Florida | Recruiting |
| Florida Medical Clinic - Orlando Health | Zephyrhills | Florida | Recruiting |
| Digestive Healthcare of Georgia | Atlanta | Georgia | Recruiting |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | Recruiting |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | Recruiting |
| Grand Teton Research Group, PLLC | Idaho Falls | Idaho | Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | Recruiting |
| Illinois Gastroenterology Group-Glenview powered by GI Alliance | Glenview | Illinois | Recruiting |
| GI Alliance - Gurnee | Gurnee | Illinois | Recruiting |
+ 334 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Denmark
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 NCT06819878 on ClinicalTrials.gov ↗ ← All trials in Denmark