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Phase 2Recruiting

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

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

About this 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).

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.

Where this study is enrolling (15)

  • Gastro Care Institute

    Lancaster, California

    Call 661-529-7550

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  • Peak Gastroenterology Associates - Colorado Springs

    Colorado Springs, Colorado

    Call 719-362-2266

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  • Endoscopic Research Inc

    Orlando, Florida

    Call 407-241-1726

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  • Tropical Clinical Trials

    Palmetto Bay, Florida

    Call 754-946-4172

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  • Bioresearch Partner-Kendale Lakes

    Miami, Florida

    Call 833-489-4968

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Show all 15 locations

  • Clinical Research of Osceola

    Kissimmee, Florida

    Call 407-846-6331

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  • Atlanta Gastroenterology Associates (Part of United Digestive)

    Atlanta, Georgia

    Call 404-257-9000

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  • SSM Health DePaul Hospital- St. Louis

    Bridgeton, Missouri

    Call 918-880-0676

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  • Wake Research Associates

    Raleigh, North Carolina

    Call 336-613-6908

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  • Cross Creek Medical Clinic

    Fayetteville, North Carolina

    Call 920-437-5130

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  • Peters Medical Research

    High Point, North Carolina

    Call 336-883-9773

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  • Palmetto Gastroenterology Clinical Research

    Summerville, South Carolina

    Call 843-376-0670

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  • Gastrointestinal Associates of Northeast Tennessee

    Johnson City, Tennessee

    Call 423-208-9073

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  • Prime Clinical Research - Lewisville

    Lewisville, Texas

    Call 817-907-7330

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  • Tyler Research Institute, LLC

    Tyler, Texas

    Call 903-630-6211

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Who can participate

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)

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.