Overview
This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.
Description
The purpose of this platform study is to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) to evaluate multiple oral or parenteral experimental therapies for moderately to severely active Crohn's Disease or Ulcerative Colitis.
Eligibility
Inclusion Criteria-Crohn's Disease:
- Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology
- Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD)
- Meets drug stabilization requirements
Inclusion Criteria-Ulcerative Colitis:
- Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology
- Moderately to severely active UC as defined by a 3-component MMCS
- Meets drug stabilization requirements
Exclusion Criteria-Crohn's Disease:
- Diagnosis of indeterminate colitis
- Suspected or diagnosed intra-abdominal or perianal abscess at Screening
- Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments
- CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
Exclusion Criteria-Ulcerative Colitis:
- Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
- Current stoma or impending need for colostomy or ileostomy
- Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase
- Previous total proctocolectomy or subtotal colectomy