Afimkibart subcutaneous induction in moderately to severely active ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares subcutaneous afimkibart to placebo in adults with moderately to severely active ulcerative colitis. Eligible participants have failed or intolerated at least one standard UC therapy and meet weight and screening criteria. The study aims to determine efficacy and safety during induction, with ongoing monitoring for adverse events. The trial is led by Hoffmann-La Roche with collaborators and is conducted at Gastro One in Cordova, Tennessee. Participants will be randomized to receive afimkibart or placebo and will be evaluated for changes in disease activity and safety outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gastro One
  Cordova, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.