Tests MORF-057 for moderately to severely active Crohn's disease
Tests MORF-057 against placebo in adults with active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Atlanta, Bridgeton, Cedar Park, Colorado Springs, Denton, Fayetteville, High Point, Houma, Houston, Johnson City, Kissimmee, Lancaster, Lewisville, Lynchburg, Mansfield, Miami, North Las Vegas, Ogden, Orlando, Palmetto Bay, Raleigh, San Diego, Summerville, and Tyler, United StatesSee the 25 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 United States
- Atlanta Gastroenterology Associates (Part of United Digestive)Atlanta, United StatesTaking people
- Atlanta Gastroenterology Specialists, PCAtlanta, United StatesTaking people
- SSM Health DePaul Hospital- St. LouisBridgeton, United StatesTaking people
- GI Alliance - Cedar ParkCedar Park, United StatesTaking people
- Peak Gastroenterology Associates - Colorado SpringsColorado Springs, United StatesTaking people
- North Texas GastroenterologyDenton, United StatesNot yet recruiting
- Cross Creek Medical ClinicFayetteville, United StatesTaking people
- Peters Medical ResearchHigh Point, United StatesTaking people
- Tandem Clinical ResearchHouma, United StatesTaking people
- The University of Texas Health Science Center at HoustonHouston, United StatesTaking people
- Gastrointestinal Associates of Northeast TennesseeJohnson City, United StatesTaking people
- Clinical Research of OsceolaKissimmee, United StatesTaking people
- Gastro Care InstituteLancaster, United StatesTaking people
- Prime Clinical Research - LewisvilleLewisville, United StatesTaking people
- Gastroenterology Associates of Central VirginiaLynchburg, United StatesTaking people
- Prime Clinical ResearchMansfield, United StatesTaking people
- Bioresearch Partner-Kendale LakesMiami, United StatesTaking people
- Las Vegas Clinical TrialsNorth Las Vegas, United StatesTaking people
- Care Access Research, OgdenOgden, United StatesTaking people
- Endoscopic Research, IncOrlando, United StatesTaking people
- Tropical Clinical TrialsPalmetto Bay, United StatesTaking people
- Wake Research AssociatesRaleigh, United StatesNo longer taking part
- Infinity Clinical ResearchSan Diego, United StatesTaking people
- Palmetto Gastroenterology Clinical ResearchSummerville, United StatesTaking people
- Tyler Research Institute, LLCTyler, United StatesTaking 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.