Evaluating MORF-057 for treating active Crohn's disease in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study is designed to assess the efficacy and safety of two active dose regimens of MORF-057 compared to a placebo in adults suffering from moderately to severely active Crohn's disease. Participants will undergo a 14-week induction period followed by a 38-week maintenance period where all will receive open-label MORF-057. The study aims to determine how well this treatment works for individuals who have not responded adequately to previous therapies. The total treatment duration for participants who complete the study will be 52 weeks, with an option for a maintenance extension.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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)

Key Exclusion Criteria:

* 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 it's running

• Gastro Care Institute
  Lancaster, California, United States Recruiting
• Infinity Clinical Research
  San Diego, California, United States Recruiting
• Peak Gastroenterology Associates - Colorado Springs
  Colorado Springs, Colorado, United States Recruiting
• Clinical Research of Osceola
  Kissimmee, Florida, United States Recruiting
• Bioresearch Partner-Kendale Lakes
  Miami, Florida, United States Recruiting
• Endoscopic Research Inc
  Orlando, Florida, United States Recruiting

+174 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.