A Phase 2 Platform Study to Evaluate Therapies for Inflammatory Bowel Disease

Prior treatment

• Participants with any serious bacterial infection within 3 months prior to Screening.
• CD patients: Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments.
• UC patients: Previous total proctocolectomy or subtotal colectomy.
• Participants who are scheduled or anticipate the need for surgery, aside from dermatologic or other minor outpatient procedures.
• Current symptoms of severe, progressive, or uncontrolled system disease. Concomitant medical conditions that, in the opinion of the Investigator, might place the participant at unacceptable risk for participation in this study.
• Participants with concomitant primary sclerosing cholangitis.

Other illness

• Stool positive for Clostridioides difficile (C. difficile) infection.
• Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
• Allergy to intervention or any of the excipients.
• UC patients: Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation.
• Participants who have a known history of clinically significant drug or alcohol abuse, in the opinion of the Investigator.
• Participants with a history of cancer within the 5 years prior to Screening (other than non-melanoma skin cell cancers cured by local resection).
• Participants at risk for tuberculosis (TB).

Lab values

• Clinically significantly abnormal laboratory values.

Other

• Women who are pregnant or breastfeeding.
• Positive stool polymerase chain reaction (PCR) or culture for enteric pathogens.
• Legal or mental incapacitation, or inability to understand and comply with the requirements of the study.
• CD patients: Diagnosis of indeterminate colitis.
• CD patients: Suspected or diagnosed intra-abdominal or perianal abscess at Screening.
• CD patients: Current stoma or impending need for ostomy or participants with ileo-anal pouch.
• Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis.
• CD patients: CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
• Past or current evidence of definite low-grade or high-grade colonic dysplasia that has not been completely removed.

• ≥ 18 to ≤ 80 years old.
• UC: Moderately to severely active UC.
• UC: Participants must meet drug stabilization requirements.
• Able to provide written informed consent and understand and comply with the requirements of the study specified both in the Master Protocol and the ISA.
• Participants must have had insufficient response and/or intolerance to corticosteroid, immunosuppressants, and/or an approved advanced therapy for UC or CD.
• Female participants must be of non-childbearing potential or have a negative serum pregnancy test at time of Screening if of childbearing potential. Additional requirements for birth control methods apply for each ISA.
• CD: Documented diagnosis of CD.
• CD: Moderately to severely active CD as defined by CDAI.
• CD: SES-CD (per central reading) consistent with moderate to severely active CD.
• CD: Participants must meet drug stabilization requirements.
• UC: Documented diagnosis of UC.