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Recruiting Phase 3

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

NCT06819891 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2025-05-12
Last updated
2026-09-28

Condition(s) studied

Moderately to Severely Active Crohns Disease

Investigational drug(s) / intervention(s)

Afimkibart →Placebo

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

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 * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * 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, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed * 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)

  • 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)

FacilityCityRegionStatus
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.

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 NCT06819891 on ClinicalTrials.gov ↗ ← All trials in Spain