A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Alberta, Chicoutimi, Halifax, Lethbridge, London, Montreal, Québec, Scarborough, Toronto, and Vaughan, CanadaSee the 12 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06226883, who can take part
Where in Canada
- CaRe ClinicAlberta, CanadaNot yet recruiting
- Integrated University Health and Social Services Center of Saguenay-Lac-Saint-JeanChicoutimi, CanadaNot yet recruiting
- Nova Scotia Health AuthorityHalifax, CanadaTaking people
- Prairie Institute of Liver and Luminal Advanced ResearchLethbridge, CanadaNot yet recruiting
- London Digestive Disease InstituteLondon, CanadaTaking people
- London Health Sciences CentreLondon, CanadaTaking people
- Clinique IMDMontreal, CanadaTaking people
- Diex Recherche Québec Inc.Québec, CanadaTaking people
- Scarborough Center for Inflammatory Bowel DiseaseScarborough, CanadaTaking people
- Mount Sinai HospitalToronto, CanadaTaking people
- St Joseph'S Health Centre TorontoToronto, CanadaTaking people
- Toronto Digestive Disease Associates, Inc.Vaughan, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
- Trial code
- NCT06226883EU 2023-508158-24-00
- Record updated
- 4 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
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).
Inclusion: 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).
Exclusion: Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC; Is currently receiving total parenteral nutrition, tube feeding, or a formula diet; 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; Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome; Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease; Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement; Has positive findings on a subjective neurological screening questionnaire; Unable to attend study visits or comply with study procedures.