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

Launched by HOFFMANN-LA ROCHE · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RO7790121 for people with moderately to severely active Crohn's disease, a condition that causes inflammation in the digestive tract. The trial aims to understand how effective and safe this treatment is. It is currently recruiting participants aged 18 years and older who have been diagnosed with Crohn's disease and have not responded well to other treatments. To join the study, individuals must weigh at least 40 kilograms and meet specific health criteria.

Participants in this trial can expect to receive either the active treatment or a placebo (a substance with no active effect) during the study. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the active treatment, which helps ensure the results are unbiased. It's important to note that certain health conditions, like other types of inflammatory bowel diseases or specific infections, may prevent someone from participating. This study provides a chance to contribute to research that could improve treatment options for 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
• • 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