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

Launched by HOFFMANN-LA ROCHE · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called RO7790121 for people with moderately to severely active Crohn's disease, which is a condition that causes inflammation in the digestive tract. The study aims to find out if this treatment is effective and safe for patients who have not responded well to other therapies. It is a Phase III trial, meaning it is in the later stages of testing, and will involve multiple centers to gather data from a larger group of participants.

To be eligible for the study, participants must have a confirmed diagnosis of Crohn's disease and must weigh at least 40 kilograms. They should also have had inadequate responses or issues with at least one previous Crohn's treatment. It's important to note that certain conditions, like ulcerative colitis or a history of multiple bowel surgeries, may exclude someone from participating. Those who join the trial can expect to receive either the new treatment or a placebo (a harmless substance with no active treatment) and will be monitored closely by the research team throughout the study. If you or someone you know is considering participation, it may be a chance to explore new options for managing Crohn's disease.

Gender

ALL

Eligibility criteria

• 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, 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