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New treatment option for Inflammatory Bowel Diseases
Official title A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT06226883
What this study is testing
What is MORF-057?
MORF-057 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for inflammatory bowel diseases.
Also referred to as zotemtegrast.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Lancaster, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Palmetto Bay, Florida, United States
- Atlanta, Georgia, United States
- Houma, Louisiana, United States
- Bridgeton, Missouri, United States
- North Las Vegas, Nevada, United States
- Fayetteville, North Carolina, United States
- High Point, North Carolina, United States
- Raleigh, North Carolina, United States
- Summerville, South Carolina, United States
- Johnson City, Tennessee, United States
- Cedar Park, Texas, United States
- Denton, Texas, United States
- Houston, Texas, United States
- Lewisville, Texas, United States
+ 161 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lancaster, California, United States; San Diego, California, United States; Colorado Springs, Colorado, United States; Kissimmee, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States and 175 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.