RECRUITING

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

Conditions

Inflammatory Bowel Diseases Crohn's Disease Crohn's disease (CD)Inflammatory bowel disease (IBD)a4b7 Moderate-to-severe Integrin GARNET

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2024-07-18

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06226883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Gastro Care Institute

Lancaster, California, 93534

United States

Wake Research Associates

Raleigh, North Carolina, 27612

United States

Palmetto Gastroenterology Clinical Research

Summerville, South Carolina, 29486

United States

Gastrointestinal Associates of Northeast Tennessee

Johnson City, Tennessee, 44060

United States

GI Alliance - Cedar Park

Cedar Park, Texas, 78613

United States

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Texas Digestive Disease Consultants

San Marcos, Texas, 76092

United States

Tyler Research Institute, LLC

Tyler, Texas, 75701

United States

Care Access Research - Ogden

Ogden, Utah, 84403

United States

Gastroenterology Associates of Central Virginia

Lynchburg, Virginia, 24502

United States

Collaborators and Investigators

Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-18

Study Completion Date2028-08

Study Record Updates

Study Start Date2024-07-18

Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

Crohn's disease (CD)
Inflammatory bowel disease (IBD)
a4b7
Moderate-to-severe
Integrin
GARNET

Additional Relevant MeSH Terms

Inflammatory Bowel Diseases
Crohn's Disease