[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06226883":3,"trial-entities:NCT06226883":2560,"trial-summary:NCT06226883":2564},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":53,"secondary_outcomes":58,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":88,"locations":91,"central_contacts":2545,"overall_officials":2553,"references":2558,"see_also_links":2559},"NCT06226883","27383","A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","RECRUITING","2030-06","2026-08","2026-08-21","2024-07-18","Morphic Therapeutic, Inc. 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All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.",[19,20],"Inflammatory Bowel Diseases","Crohn's Disease",[22,23,24,25,26,27],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin","GARNET","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},385,"ESTIMATED",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","Placebo","Matching placebo (identical appearance to MORF-057) administered orally.",[41,42],"Group 3 (Part A)","Group 6 (Part B)",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":51},"MORF-057","MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.",[47,48,41,49,50,42],"Group 1 (Part A)","Group 2 (Part A)","Group 4 (Part B)","Group 5 (Part B)",[52],"zotemtegrast",[54],{"measure":55,"description":56,"timeFrame":57},"Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)","The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%","Baseline to Week 14",[59,62],{"measure":60,"description":61,"timeFrame":57},"Proportion of participants with clinical response at Week 14 as determined using the Crohn's Disease Activity Index (CDAI)","The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical response is defined as a reduction from baseline CDAI score by ≥100 points or a CDAI score of \\\u003C150 points.",{"measure":63,"description":64,"timeFrame":57},"Proportion of participants with clinical remission at Week 14 as determined using the CDAI.","The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. 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demyelinating, or neurodegenerative disease","Key Inclusion Criteria:\n\n* Has signs\u002Fsymptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and\u002For an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* 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\u002For advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and\u002For more than 3 resections, and\u002For has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and\u002For a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative 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It will compare three different doses of MORF-057 to a placebo.","completed","Phase 2 Study of MORF-057 for Crohn's Disease","This Phase 2 study is testing a new oral medication called MORF-057 for adults with moderately to severely active Crohn's disease (CD). MORF-057 works by selectively blocking integrin α4β7, which is involved in inflammation. The study will compare MORF-057 to a placebo (an inactive pill that looks the same) to see how well it works and if it's safe. Researchers will measure how many participants show an endoscopic response (improvement seen during an endoscopy) after 14 weeks. You might be able to join if you are between 18 and 85 years old, have had Crohn's symptoms for at least 90 days, and your current treatments haven't worked well enough. 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