A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active... | NCT06819891 | Trialant

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active... | NCT06819891 | Trialant

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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, 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