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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
You may not be if
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
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
Clareo Health | A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
