Cure8 trial brief
Patients with UC often take multiple medicines that rely on CYP enzymes. This study is checking if afimkibart affects how those drugs are processed, which could matter for safety or dosing if the drug proceeds in development.
Adults with moderately to severely active ulcerative colitis, clinicians managing multi-drug regimens, pharmacologists, and researchers studying drug–drug or disease–drug interactions.
This is a phase 1 interventional trial (NCT07665723) testing afimkibart (RO7790121) in adults with moderately to severely active ulcerative colitis to see whether afimkibart changes how CYP enzymes process common probe drugs.
The study gives participants a CYP probe cocktail (including caffeine, warfarin, omeprazole, dextromethorphan and midazolam probes) before and after dosing with afimkibart and measures standard PK outcomes (AUC, Cmax, Tmax, t1/2) over about 13 weeks. The trial is recruiting, plans to enroll about 25 participants, and includes an optional long-term extension.
Key inclusion requires endoscopically confirmed moderate–severe UC (modified Mayo 5–9 with endoscopic subscore 2–3). Major IBD exclusions include Crohn’s disease, presence of an ostomy or pouch, and primary sclerosing cholangitis. Multiple US and international sites are listed.
This record is a trial registration (protocol and planned outcomes) rather than a report of results; it describes what the study will measure, not findings.
This is a phase 1 registered trial (recruiting) and the record describes planned pharmacokinetic measurements and eligibility. It is not a publication of results; do not interpret this as evidence that afimkibart affects other drugs.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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