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RECRUITINGPhase 2INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Key Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Placebo

Matching placebo (identical appearance to MORF-057) administered orally.

DRUG

MORF-057

MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Locations (20)

Gastro Care Institute
Lancaster, California, United States
Infinity Clinical Research
San Diego, California, United States
Peak Gastroenterology Associates - Colorado Springs
Colorado Springs, Colorado, United States
Clinical Research of Osceola
Kissimmee, Florida, United States
Bioresearch Partner-Kendale Lakes
Miami, Florida, United States
Atlanta Gastroenterology Specialists, PC
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates (Part of United Digestive)
Atlanta, Georgia, United States
Cross Creek Medical Clinic
Fayetteville, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Palmetto Gastroenterology Clinical Research
Summerville, South Carolina, United States
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, United States
GI Alliance - Cedar Park
Cedar Park, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Texas Digestive Disease Consultants
San Marcos, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Care Access Research - Ogden
Ogden, Utah, United States
Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, United States
Medical University Hematology
Innsbruck, Austria
Salzburg Regional Hospital
Salzburg, Austria