A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis

Korábbi kezelés

• Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy.

Más betegség

• Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis.
• History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell 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).
• Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB.

Egyéb

• Currently known complications of UC (e.g. fulminant colitis, toxic megacolon).
• Presence of an ostomy or ileoanal pouch.
• Current diagnosis or suspicion of primary sclerosing cholangitis.
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study.
• Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed.

• Confirmed diagnosis of UC.
• Moderately to severely active UC assessed by modified Mayo Score (mMS).
• Bodyweight >= 40 kilogram (kg).
• Up to date with colorectal cancer (CRC) screening performed according to local standards.
• Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy.
• Females of childbearing potential must meet protocol criteria for contraception requirements.