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

Description

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Conditions

Inflammatory Bowel Diseases, Crohn's Disease

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Study Overview

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Study Details

Study overview

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)

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

Condition
Inflammatory Bowel Diseases
Intervention / Treatment

-

Contacts and Locations

Lancaster

Clinical Study Site, Lancaster, California, United States, 93534

Shreveport

Clinical Study Site, Shreveport, Louisiana, United States, 71105

Raleigh

Clinical Study Site, Raleigh, North Carolina, United States, 27612

Summerville

Clinical Study Site, Summerville, South Carolina, United States, 29486

Johnson City

Clinical Study Site, Johnson City, Tennessee, United States, 37604

Cedar Park

Clinical Study Site, Cedar Park, Texas, United States, 78613

Houston

Clinical Study Site, Houston, Texas, United States, 77030

Southlake

Clinical Study Site, Southlake, Texas, United States, 78666

Tyler

Clinical Study Site, Tyler, Texas, United States, 75701

Ogden

Clinical Study Site, Ogden, Utah, United States, 84403

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Has signs/symptoms of CD for at least 3 months 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)
  • * Agrees to abide by the study guidelines and requirements
  • * Capable of giving signed informed consent
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Morphic Therapeutic, Inc,

Study Record Dates

2028-06