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

NCT06226883

RecruitingPhase 2

Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Conditions: Inflammatory Bowel Diseases, Crohn's Disease

Interventions: Placebo, MORF-057

Countries: United States, Australia, Austria, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (225)
  • Lancaster, California, United States
  • San Diego, California, United States
  • Colorado Springs, Colorado, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Palmetto Bay, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Houma, Louisiana, United States
  • Bridgeton, Missouri, United States
  • North Las Vegas, Nevada, United States
  • Fayetteville, North Carolina, United States
  • High Point, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Summerville, South Carolina, United States
  • Johnson City, Tennessee, United States
  • Cedar Park, Texas, United States
  • Denton, Texas, United States
  • Houston, Texas, United States
  • Lewisville, Texas, United States
  • Mansfield, Texas, United States
  • Tyler, Texas, United States
  • Ogden, Utah, United States
  • Lynchburg, Virginia, United States
  • Bedford Park, Australia
  • Herston, Australia
  • Kurralta Park, Australia
  • Melbourne, Australia
  • Melbourne, Australia
  • + 195 more on CT.gov