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RecruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well three dose plans of MORF-057 work and how safe they are for adults with moderate to severe active Crohn’s disease. It compares MORF-057 with a placebo, a treatment with no active drug.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had signs or symptoms of Crohn’s disease for at least 90 days before screening.
  • Have a Crohn’s disease activity score (CDAI) of 220 to 450, with an average daily stool score of at least 4 and/or belly pain score of at least 2.
  • Have a bowel exam score (SES-CD) of at least 6, or at least 4 if Crohn’s affects only the ileum, the last part of the small bowel.
  • Have tried at least one Crohn’s treatment that did not work well enough, stopped working, or caused side effects you could not tolerate. These include steroids, drugs that reduce immune activity, or advanced treatments such as biologic drugs or JAK inhibitors.

Who can't join

  • Have another listed type of colon inflammation: indeterminate, microscopic, ischemic, or radiation colitis, or ulcerative colitis (UC). Signs suggesting UC also rule you out.
  • Have Crohn’s only in the mouth, stomach, upper or middle small bowel, or area around the anus, without disease in the colon or ileum.
  • Have had more than 100 cm of bowel removed, more than 3 bowel removal surgeries, or short bowel syndrome. Also excluded if you currently get all nutrition through a vein, use tube feeding, or follow a formula diet.
  • Have a positive result on a nerve and brain symptom screening form, or a history of a major nerve or brain disorder, such as stroke, multiple sclerosis, brain tumor, or disease that damages nerves.
  • Have another serious, unstable health condition.
  • Have used vedolizumab, another integrin inhibitor (a type of immune treatment), or MORF-057 before, or have a known allergy to drugs that work like MORF-057.
  • Are in another study that tests a treatment or procedure, or received an experimental treatment within the past 30 days.
  • Cannot attend study visits or follow study procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (25)

CA

CO

FL

GA

  • Atlanta Gastroenterology Specialists, PC · Atlanta, GA 30024Steven Thalvinder (Thali) Sangha · Principal investigatorMore trials in Atlanta
  • Atlanta Gastroenterology Associates (Part of United Digestive) · Atlanta, GA 30342 · Study contact · 404-257-9000Nitin Gupta · Principal investigatorMore trials in Atlanta

LA

  • Tandem Clinical Research · Houma, LA 70360Conar Fitton · Principal investigatorMore trials in Houma

MO

NC

NV

SC

TN

TX

UT

  • Care Access Research - Ogden · Ogden, UT 84403Chad Gonzales · Principal investigatorMore trials in Ogden

VA

  • Gastroenterology Associates of Central Virginia · Lynchburg, VA 24502Larry Clark, Jr. · Principal investigatorMore trials in Lynchburg