Comparing 9 approaches for Crohn's disease (CD)

Exclusion

• −Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., hepatitis B surface antigen \[HBsAg\]-negative and hepatitis B antibody-positive) may, however, be included.
• −Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
• −Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV RNA).
• −Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCV RNA at least 12 weeks before baselineBaselineYour starting measurements, taken before treatment begins.Read more →\]).
• −The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
• −Participants who have received either (1) an investigational biologic (other than those listed in Exclusion CriterionExclusion criteriaThe things that would prevent someone from taking part.Read more → #1) within 60 days or 5 half-lives before screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
• −Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
• −The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 30 days prior to first dose of study drug.
• −The participants has received any live vaccinations within 30 days prior to first dose.
• −Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
• −Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \>3 small intestine resections.
• −Participants with a current diagnosis of indeterminate colitis.
• −Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
• −Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as:
• −Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
• −A TB skin test reaction ≥5 mm.
• −The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
• −Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
• −Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.
• −Other inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteria may apply.