Status:
RECRUITING
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Conditions:
Inflammatory Bowel Diseases
Crohn's Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching plac...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT06226883
Start Date
July 18 2024
End Date
June 1 2030
Last Update
March 5 2026
Active Locations (159)
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1
Gastro Care Institute
Lancaster, California, United States, 93534
2
Wake Research Associates
Raleigh, North Carolina, United States, 27612
3
Palmetto Gastroenterology Clinical Research
Summerville, South Carolina, United States, 29486
4
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, United States, 44060