A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (EMERALD-2)
Inflammatory Bowel Diseases, Colitis, Ulcerative
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), a4b7, Moderate-to-severe, Integrin, EMERALD
Eligibility Criteria
Inclusion Criteria: Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening Has evidence of UC extending at least 15 cm from the anal verge Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase [JAK] antagonists, or sphingosine-1-phosphate [S1P] receptor agonists) Subject has no prior exposure to approved or investigational anti-integrin therapies Agrees to abide by the study guidelines and requirements Capable of giving signed informed consent Exclusion Criteria: Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease 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 Participation in any other interventional study or 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Group 1
Group 2
Group 3
Group 4
MORF-057 Dosing Regimen One for Induction and Maintenance Periods
MORF-057 Dosing Regimen Two for Induction and Maintenance Periods
MORF-057 Dosing Regimen Three for Induction and Maintenance Periods
Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance