Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis - Expedition

Exclusion Criteria

• 1. Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge).
• 2. Current diagnosis of fulminant colitis, a diagnosis of CD or indeterminate colitis, presence or history of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or untreated bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of screening are excluded.
• 3. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, ileostomy, or other prior colonic resection, or need for surgical intervention for control of UC anticipated within 6 months.
• 4. Participant has received the following treatment:
• (a) Infliximab: within 8 weeks prior to randomization.
• (b) Adalimumab, certolizumab pegol, or golimumab: within 8 weeks prior to randomization.
• (c) Vedolizumab or ustekinumab within 12 weeks of randomization.
• (d) Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to randomization.
• (e) Fecal microbiota transplantation: within 8 weeks prior to randomization.
• 5. Criterion deleted as part of Amendment 5 v6.0
• 6. Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23.
• 7. Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy.
• 8. Participant received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening.
• 9. Participants who received IV or intramuscular steroids within 2 weeks prior to Screening.
• 10. Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study(s), or receiving other investigational agent(s).
• 11. Participant received a transfusion of blood, plasma, or platelets within 30 days prior to Screening.
• 12. Participant received a Bacille Calmette-Guérin vaccination within 12 months of randomization or any other live vaccine less than 4 weeks prior to randomization.
• 13. Participant has any of the following criteria related to infections:
• (a) Evidence of a recent systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment.
• (b) Any infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of Screening.
• (c) Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening.
• (d) Clinically significant chronic infection that has not resolved within 8 weeks of Screening.
• (e) Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with study medical monitor.
• (f) Clinical evidence of or suspected to have an abscess during Screening.
• (g) Any underlying condition that predisposes the participant to infections.
• (h) Participant had previous allogenic bone marrow transplant or history of organ or cell-based transplantation.
• (i) Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy.
• (j) Signs or symptoms of ongoing infection due to intestinal pathogens.
• 14. Participant has known or suspected history of chronic use of NSAIDs and/or opiates, drug, or alcohol abuse.
• 15. History of cancer with the following exceptions: history of basal cell carcinoma and/or squamous cell carcinoma of the skin OR carcinoma in situ of the cervix; with apparent successful curative therapy, greater than 12 months prior to Screening.
• 16. Clinically significant cardiovascular conditions.
• 17. Prolonged QTcF interval or conditions leading to additional risk for QT prolongation.
• 18. Clinically significant kidney disease
• 19. Abnormal laboratory results at Screening as defined in the study protocol
• 20. Participant is pregnant or breastfeeding or plans to become pregnant during the study.
• 21. Participant has other known, pre-existing, clinically significant medical conditions that are not associated with UC and are uncontrolled with standard treatment.
• 22. Participant has any disorder that may compromise the ability of the participant to give written informed consent and/or to comply with all required study procedures.
• 23. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
• Complete exclusion criteria are in the Clinical Study Protocol