How afimkibart may affect medicine processing in people with 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 1 interventional study examines the drug-drug interaction potential of afimkibart by measuring the pharmacokinetics of cytochrome P450 enzyme substrates alone and after afimkibart in adults with active ulcerative colitis. The study uses a multi-substance approach with probes including caffeine, warfarin, omeprazole, and dextromethorphan to see how afimkibart affects their metabolism. Enrollment targets participants with confirmed UC and active disease, aligned with specific endoscopic and Mayo scores. Safety monitoring and centralized endoscopy reviews are likely part of the protocol given the disease context. The goal is to understand whether afimkibart alters drug levels and exposure in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Body weight \>= 40kg
* Agreement to adhere to the contraceptive requirements

UC Specific Inclusion Criteria:

* Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence
* Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending \>=15 cm from the anal verge
* Moderately to severely active UC, defined as an modified Mayo score of 5 to 9 points, including a Mayo endoscopic subscore of 2 or 3, confirmed through centrally read endoscopy

Exclusion Criteria:

Inflammatory Bowel Disease (IBD) Exclusion Criteria:

* Current diagnosis of Crohn's disease (CD),abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
* Presence of an ostomy or ileoanal pouch
* Current diagnosis or suspicion of primary sclerosing cholangitis

Medical History Exclusion Criteria:

* Lack of peripheral venous access
* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
* History of alcohol, drug, or chemical abuse \< 1 year prior to screening

Where it's running

• Erick H. Alayo Medical Corporation - Gastro SB Clinic
  Chula Vista, California, United States Recruiting
• Allied Biomedical Research Institute, Inc
  Miami, Florida, United States Recruiting
• Gastro Health Research
  Miami, Florida, United States Recruiting
• UZ Leuven Gasthuisberg
  Leuven, Belgium Recruiting
• AZ Delta (Campus Rumbeke)
  Roeselare, Belgium Recruiting
• Charite Research Organisation GmbH
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Reference Study ID Number : GA46438 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.