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

RecruitingPhase 2

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)

Who can join

Ages 18 to 85 · All sexes

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) · Participants: 385 · Started: Jul 18, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06226883

Locations in the U.S.

CaliforniaGastro Care Institute, Lancaster
Infinity Clinical Research, San Diego (Not yet recruiting)
ColoradoPeak Gastroenterology Associates - Colorado Springs, Colorado Springs
FloridaClinical Research of Osceola, Kissimmee
Bioresearch Partner-Kendale Lakes, Miami
Endoscopic Research Inc, Orlando
Tropical Clinical Trials, Palmetto Bay
GeorgiaAtlanta Gastroenterology Associates (Part of United Digestive), Atlanta
Atlanta Gastroenterology Specialists, PC, Atlanta
LouisianaTandem Clinical Research, Houma
MissouriSSM Health DePaul Hospital- St. Louis, Bridgeton
NevadaLas Vegas Clinical Trials, North Las Vegas
North CarolinaCross Creek Medical Clinic, Fayetteville
Peters Medical Research, High Point
Wake Research Associates, Raleigh (Not yet recruiting)
South CarolinaPalmetto Gastroenterology Clinical Research, Summerville
TennesseeGastrointestinal Associates of Northeast Tennessee, Johnson City
TexasGI Alliance - Cedar Park, Cedar Park
North Texas Gastroenterology, Denton (Not yet recruiting)
The University of Texas Health Science Center at Houston, Houston
Prime Clinical Research - Lewisville, Lewisville
Prime Clinical Research, Mansfield
Tyler Research Institute, LLC, Tyler
UtahCare Access Research - Ogden, Ogden
VirginiaGastroenterology Associates of Central Virginia, Lynchburg

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.