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Clinical Trials in the USA / NCT06819878
Recruiting Phase 3

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

NCT06819878 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2025-03-17
Last updated
2026-09-16

Condition(s) studied

Moderately to Severely Active Crohns Disease

Investigational drug(s) / intervention(s)

AfimkibartPlacebo

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

Sex
ALL
Min age
16 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Confirmed diagnosis of CD * Moderately to severely active CD * Bodyweight \>= 40 kilogram (kg) * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy * Males and females of childbearing potential must meet protocol criteria for contraception requirements Exclusion Criteria: * Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis * Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum) * Diagnosis of short gut or short bowel syndrome * Presence of an ileostomy, colostomy or ileoanal pouch * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * Presence of abdominal or perianal abscess * Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings * Current diagnosis or suspicion of primary sclerosing cholangitis * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia * History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening * 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

Primary outcome measure(s)

Trial sites (374)

FacilityCityRegionStatus
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 the USA

Other trials for the same condition

Official registry record

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 the USA