What are the study criteria?

Patients must satisfy the following criteria to be enrolled in the study:

  • Diagnosis of moderately to severely active Crohn’s disease, defined as CDAI score ≥ 220 and ≤ 450
  • An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
  • Disease duration of ≥ 3 months prior to screening
  • Diagnosis confirmed by clinical and endoscopic evidence and corroborated by a histology report (note: endoscopy and histopathology confirmation may be obtained during Screening if no prior report is readily available)
  • Total SES-CD ≥ 6 or ileum segmental SES-CD ≥ 4
  • Failure of or intolerance to at least one of the following: corticosteroids, immunomodulators or biologics (e.g., ustekinumab, TNFα antagonists or vedolizumab) for the treatment of Crohn’s disease

*Other eligibility criteria will apply

The presence of any of the following will exclude a patient from enrollment:

  • Diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, radiation colitis or has known strictures or stenosis leading to symptoms of obstruction
  • Need for bowel resection within 12 weeks of entry into the study, in physician’s judgment
  • Extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome
  • Requirement for total parenteral nutrition

*Other eligibility criteria will apply

YELLOWSTONE Induction 1 and 2 are enrolling patients aged 18 and older.