A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Prior treatment

• Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
• Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
• Has a concurrent, clinically significant, serious, unstable comorbidity
• Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
• Is currently participating in any other interventional study or has received any investigational therapy within 30 days
• Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057

Other illness

• Has had extensive bowel resection (\>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
• Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease

Other

• Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
• Has positive findings on a subjective neurological screening questionnaire
• Unable to attend study visits or comply with study procedures

• Has signs/symptoms of CD for at least 90 days prior to screening
• Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points
• Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)
• Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase \[JAK\] inhibitors, applicable investigational products)