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

RecruitingPhase 3Ages 16 Years - 80 YearsAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Currently known complications of UC (e.g. fulminant colitis, toxic megacolon). * Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis. * 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. * 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. * Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy.
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What it tests

  • Afimkibart
  • Placebo
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Where

1 site
Gastro One
Cordova, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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