Clareo Health | 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
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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CONTACT
Lead
Hoffmann-La Roche
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Body weight \>= 40kg
Agreement to adhere to the contraceptive requirements
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
You may not be if
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
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
