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RecruitingPhase 2

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

Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) · NCT06226883

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
385
US sites recruiting
23
Study start
July 18, 2024
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Placebo; MORF-057

Conditions: Inflammatory Bowel Diseases; Crohn's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Gastro Care Institute

    Lancaster, CA 93534

    Site contact: 661-529-7550

  • Infinity Clinical Research

    San Diego, CA 92108

    Site contact: Tommy Yen

  • Peak Gastroenterology Associates - Colorado Springs

    Colorado Springs, CO 80921

    Site contact: 719-362-2266

  • Clinical Research of Osceola

    Kissimmee, FL 34741

    Site contact: 407-846-6331

  • Bioresearch Partner-Kendale Lakes

    Miami, FL 33155

    Site contact: 833-489-4968

  • Endoscopic Research Inc

    Orlando, FL 32803

    Site contact: 407-241-1726

  • Tropical Clinical Trials

    Palmetto Bay, FL 33176

    Site contact: 754-946-4172

  • Atlanta Gastroenterology Specialists, PC

    Atlanta, GA 30024

    Site contact: Steven Thalvinder (Thali) Sangha

  • Atlanta Gastroenterology Associates (Part of United Digestive)

    Atlanta, GA 30342

    Site contact: 404-257-9000

  • Tandem Clinical Research

    Houma, LA 70360

    Site contact: Conar Fitton

  • SSM Health DePaul Hospital- St. Louis

    Bridgeton, MO 063044

    Site contact: 918-880-0676

  • Las Vegas Clinical Trials

    North Las Vegas, NV 89030

    Site contact: Christian Stone

  • Cross Creek Medical Clinic

    Fayetteville, NC 28304

    Site contact: 920-437-5130

  • Peters Medical Research

    High Point, NC 27260

    Site contact: 336-883-9773

  • Palmetto Gastroenterology Clinical Research

    Summerville, SC 29486

    Site contact: 843-376-0670

  • Gastrointestinal Associates of Northeast Tennessee

    Johnson City, TN 44060

    Site contact: 423-208-9073

  • GI Alliance - Cedar Park

    Cedar Park, TX 78613

    Site contact: Junaid Siddiqui

  • The University of Texas Health Science Center at Houston

    Houston, TX 77030

    Site contact: Tugrul Purnak

  • Prime Clinical Research - Lewisville

    Lewisville, TX 75067

    Site contact: 817-907-7330

  • Prime Clinical Research

    Mansfield, TX 76063

    Site contact: Olufemi Abiodun

  • Tyler Research Institute, LLC

    Tyler, TX 75701

    Site contact: 903-630-6211

  • Care Access Research - Ogden

    Ogden, UT 84403

    Site contact: Chad Gonzales

  • Gastroenterology Associates of Central Virginia

    Lynchburg, VA 24502

    Site contact: Larry Clark, Jr.

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to… (NCT06226883) | Bored Studies