A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's
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).
| Condition(s) | Inflammatory Bowel Diseases, Crohn's Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 to severely active Crohn's disease (CD). |
| Who can participate | 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 finding |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) |
| Locations | 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 (+220 more sites) |
| Start date | 2024-07-18 |
| NCT ID | NCT06226883 |
| Official listing | https://clinicaltrials.gov/study/NCT06226883 |