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

What this study is about

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)

🚫 You may not be able to join if…

• Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
• Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
• Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
• Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
• Has positive findings on a subjective neurological screening questionnaire
• 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
• Unable to attend study visits or comply with study procedures
• Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease

Where this trial is running

• Gastro Care Institute, Lancaster, California, United States
• Infinity Clinical Research, San Diego, California, United States
• Peak Gastroenterology Associates - Colorado Springs, Colorado Springs, Colorado, United States
• Clinical Research of Osceola, Kissimmee, Florida, United States
• Bioresearch Partner-Kendale Lakes, Miami, Florida, United States
• Endoscopic Research Inc, Orlando, Florida, United States
• Tropical Clinical Trials, Palmetto Bay, Florida, United States
• Atlanta Gastroenterology Specialists, PC, Atlanta, Georgia, United States
• Atlanta Gastroenterology Associates (Part of United Digestive), Atlanta, Georgia, United States
• Tandem Clinical Research, Houma, Louisiana, United States
• SSM Health DePaul Hospital- St. Louis, Bridgeton, Missouri, United States
• Las Vegas Clinical Trials, North Las Vegas, Nevada, United States

+ 213 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06226883.