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Clinical Trials in China / NCT06226883
Recruiting Phase 2

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

NCT06226883 · tracked via the Priya Life Science China tracker
Sponsor
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Phase
Phase 2
Started
2024-07-18
Last updated
2026-09-04

Condition(s) studied

Inflammatory Bowel DiseasesCrohn's Disease

Investigational drug(s) / intervention(s)

PlaceboMORF-057

Placebo: Matching placebo (identical appearance to MORF-057) administered orally.

MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (225)

FacilityCityRegionStatus
Gastro Care Institute Lancaster California Recruiting
Infinity Clinical Research San Diego California Not Yet Recruiting
Peak Gastroenterology Associates - Colorado Springs Colorado Springs Colorado Recruiting
Clinical Research of Osceola Kissimmee Florida Recruiting
Bioresearch Partner-Kendale Lakes Miami Florida Recruiting
Endoscopic Research Inc Orlando Florida Recruiting
Tropical Clinical Trials Palmetto Bay Florida Recruiting
Atlanta Gastroenterology Specialists, PC Atlanta Georgia Recruiting
Atlanta Gastroenterology Associates (Part of United Digestive) Atlanta Georgia Recruiting
Tandem Clinical Research Houma Louisiana Recruiting
SSM Health DePaul Hospital- St. Louis Bridgeton Missouri Not Yet Recruiting
Las Vegas Clinical Trials North Las Vegas Nevada Not Yet Recruiting
Cross Creek Medical Clinic Fayetteville North Carolina Recruiting
Peters Medical Research High Point North Carolina Recruiting
Wake Research Associates Raleigh North Carolina Not Yet Recruiting
Palmetto Gastroenterology Clinical Research Summerville South Carolina Recruiting
Gastrointestinal Associates of Northeast Tennessee Johnson City Tennessee Recruiting
GI Alliance - Cedar Park Cedar Park Texas Recruiting
North Texas Gastroenterology Denton Texas Not Yet Recruiting
The University of Texas Health Science Center at Houston Houston Texas Recruiting
Prime Clinical Research - Lewisville Lewisville Texas Recruiting
Prime Clinical Research Mansfield Texas Recruiting
Tyler Research Institute, LLC Tyler Texas Recruiting
Care Access Research - Ogden Ogden Utah Recruiting
Gastroenterology Associates of Central Virginia Lynchburg Virginia Recruiting
Southern Adelaide Local Health Network Bedford Park Australia Not Yet Recruiting
Royal Brisbane and Women's Hospital Herston Australia Not Yet Recruiting
IBD SA SA Group of Specialists Kurralta Park Australia Not Yet Recruiting
The Alfred Hospital Melbourne Australia Not Yet Recruiting
St. Vincent's Hospital Melbourne Australia Not Yet Recruiting
Royal Perth Hospital Perth Australia Not Yet Recruiting
Sir Charles Gairdner Hospital Perth Australia Not Yet Recruiting
Princess Alexandra Hospital, Metro South Health Woolloongabba, QLD Australia Not Yet Recruiting
Medical University Hematology Innsbruck Austria Recruiting
Salzburg Regional Hospital Salzburg Austria Recruiting
University Hospital St. Poelten Sankt Pölten Austria Recruiting
Medical University of Vienna Vienna Austria Recruiting
University Clinical Centre of the Republic of Srpska Banja Luka Bosnia and Herzegovina Not Yet Recruiting
Hospital Plava Medical Group Tuzla Bosnia and Herzegovina Not Yet Recruiting
Cantonal Hospital Zenica, Department of Internal Medicine Zenica Bosnia and Herzegovina Not Yet Recruiting

+ 185 more sites — see the full list on the official registry below.

More Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06226883 on ClinicalTrials.gov ↗ ← All trials in China