A Phase 2b, Randomized, Double-blind, Placebo-controlledStudy to Evaluate the Safety and Efficacy of 3 Active DoseRegimens of MORF-057 in Adults with Moderately to SeverelyActive Ulcerative Colitis (EMERALD-2) - EMERALD-2

Morphic Therapeutic, Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1. Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening
•2. Has evidence of UC extending at least 15 cm from the anal verge
•3. 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)
•4. Subject has no prior exposure to approved or investigational anti-integrin therapies
•5. Agrees to abide by the study guidelines and requirements
•6. Capable of giving signed informed consent

•1. Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohns disease or has clinical findings suggestive of Crohns disease
•2. Has positive findings on a subjective neurological screening questionnaire
•3. Has a concurrent, clinically significant, serious, unstable comorbidity
•4. Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
•5. Participation in any other interventional study or received any investigational therapy within 30 days
•6. Previous exposure to MORF057 and or a known hypersensitivity to drugs with a similar mechanism to MORF057
•7. Unable to attend study visits or comply with study procedures.

发起方