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

Launched by MORPHIC THERAPEUTIC, INC · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called MORF-057 to see how well it works and how safe it is for adults with moderately to severely active Crohn's disease, which is a condition that causes inflammation in the digestive tract. The study involves comparing the effects of MORF-057 with a placebo (a treatment that does not contain the active drug) to understand its potential benefits. The trial is currently recruiting participants aged 18 to 80 who have been experiencing symptoms of Crohn's disease for at least three months and have had limited success with other treatments.

To participate, individuals need to have a specific score that shows their Crohn's disease is active, and they should have tried at least one other treatment without getting better. Participants will need to attend regular study visits and follow certain guidelines throughout the trial. It's important for those interested to know that they cannot have certain other health conditions or have previously received specific treatments that could affect their eligibility. This study aims to help improve treatment options for Crohn's disease, and participants will play a vital role in advancing our understanding of this condition.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Has signs/symptoms of CD for at least 3 months 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)
• • Agrees to abide by the study guidelines and requirements
• • Capable of giving signed informed consent
• 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