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An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
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Autoimmune Disorder -
Inflammatory Bowel Disease (IBD) -
Ulcerative Colitis
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Basic Details
Study Summary
The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).
Eligibility Criteria
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com