Inflammatory Bowel Diseases Clinical Trial
— EMERALD-2Official title:
A Phase 2b, 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 Ulcerative Colitis (EMERALD-2)
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).
Status | Recruiting |
Enrollment | 280 |
Est. completion date | July 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Clinical Study Site | Blacktown | New South Wales |
Australia | Clinical Study Site | Brisbane | Queensland |
Australia | Clinical Study Site | Brisbane | Queensland |
Australia | Clinical Study Site | Concord | New South Wales |
Australia | Clinical Study Site | Murdoch | Western Australia |
Australia | Clinical Study Site | Parkville | Victoria |
Austria | Clinical Study Site | Linz | |
Austria | Clinical Study Site | Salzburg | |
Austria | Clinical Study Site | Vienna | |
Bulgaria | Clinical Study Site | Ruse | |
Bulgaria | Clinical Study Site | Sofia | |
Bulgaria | Clinical Study Site | Sofia | |
Bulgaria | Clinical Study Site | Sofia | |
Bulgaria | Clinical Study Site | Sofia | |
Czechia | Clinical Study Site | Olomouc | |
Czechia | Clinical Study Site | Prague | |
Czechia | Clinical Study Site | Slaný | |
Estonia | Clinical Study Site | Pärnu | |
Estonia | Clinical Study Site | Tallinn | |
Estonia | Clinical Study Site | Tallinn | |
Estonia | Clinical Study Site | Tallinn | |
Estonia | Clinical Study Site | Tartu | |
France | Clinical Study Site | Lille | |
France | Clinical Study Site | Nice | |
France | Clinical Study Site | Pierre-Bénite | |
France | Clinical Study Site | Saint-Priest-en-Jarez | |
France | Clinical Study Site | Vandœuvre-lès-Nancy | |
Georgia | Clinical Study Site | Tbilisi | |
Georgia | Clinical Study Site | Tbilisi | |
Georgia | Clinical Study Site | Tbilisi | |
Georgia | Clinical Study Site | Tbilisi | |
Georgia | Clinical Study Site | Tbilisi | |
Germany | Clinical Study Site | Berlin | |
Germany | Clinical Study Site | Berlin | |
Germany | Clinical Study Site | Cologne | North Rhine-Westphalia |
Germany | Clinical Study Site | Heidelberg | Baden-Wuerttemberg |
Germany | Clinical Study Site | Kiel | Schleswig-Holstein |
Germany | Clinical Study Site | Leipzig | Saxony |
Germany | Clinical Study Site | Münster | North Rhine-Westphalia |
Germany | Clinical Study Site | Regensburg | Bavaria |
Germany | Clinical Study Site | Tuebingen | Baden-Wuerttemberg |
Germany | Clinical Study Site | Ulm | Baden-Wuerttemberg |
Hungary | Clinical Study Site | Budapest | |
Hungary | Clinical Study Site | Budapest | |
Hungary | Clinical Study Site | Gyongyos | |
Hungary | Clinical Study Site | Szekesfehervar | |
Hungary | Clinical Study Site | Vac | |
India | Clinical Study Site | Delhi | |
India | Clinical Study Site | Gurgaon | Haryana |
India | Clinical Study Site | Hyderabad | Telangana |
India | Clinical Study Site | Jaipur | Rajasthan |
India | Clinical Study Site | Jaipur | Rajasthan |
India | Clinical Study Site | Ludhiana | Punjab |
India | Clinical Study Site | New Delhi | Delhi |
India | Clinical Study Site | Noida | Uttar Pradesh |
India | Clinical Study Site | Secunderabad | Telangana |
India | Clinical Study Site | Surat | Gujarat |
India | Clinical Study Site | Thiruvananthapuram | Kerala |
Israel | Clinical Study Site | Be'er Sheva | |
Israel | Clinical Study Site | Jerusalem | |
Israel | Clinical Study Site | Jerusalem | |
Israel | Clinical Study Site | Nahariya | |
Israel | Clinical Study Site | Re?ovot | |
Italy | Clinical Study Site | Florence | |
Italy | Clinical Study Site | Milan | |
Italy | Clinical Study Site | Milan | |
Italy | Clinical Study Site | Milan | |
Italy | Clinical Study Site | Padova | |
Italy | Clinical Study Site | San Giovanni Rotondo | |
Italy | Clinical Study Site | Turin | |
Korea, Republic of | Clinical Study Site | Busan | |
Korea, Republic of | Clinical Study Site | Busan | |
Korea, Republic of | Clinical Study Site | Daegu | |
Korea, Republic of | Clinical Study Site | Gyeonggi-do | |
Korea, Republic of | Clinical Study Site | Seongnam-si | |
Korea, Republic of | Clinical Study Site | Seoul | |
Korea, Republic of | Clinical Study Site | Seoul | |
Latvia | Clinical Study Site | Liepaja | |
Latvia | Clinical Study Site | Riga | |
Latvia | Clinical Study Site | Riga | |
Lithuania | Clinical Study Site | Panevezys | |
Lithuania | Clinical Study Site | Vilnius | |
Poland | Clinical Study Site | Bydgoszcz | |
Poland | Clinical Study Site | Elblag | |
Poland | Clinical Study Site | Kraków | |
Poland | Clinical Study Site | Lódz | |
Poland | Clinical Study Site | Lublin | |
Poland | Clinical Study Site | Lublin | |
Poland | Clinical Study Site | Opole | |
Poland | Clinical Study Site | Poznan | |
Poland | Clinical Study Site | Poznan | |
Poland | Clinical Study Site | Sopot | |
Poland | Clinical Study Site | Staszów | |
Poland | Clinical Study Site | Szczecin | |
Poland | Clinical Study Site | Tychy | |
Poland | Clinical Study Site | Wadowice | |
Poland | Clinical Study Site | Warsaw | |
Poland | Clinical Study Site | Warsaw | |
Poland | Clinical Study Site | Wroclaw | |
Poland | Clinical Study Site | Zamosc | |
Romania | Clinical Study Site | Bucharest | |
Romania | Clinical Study Site | Bucharest | |
Romania | Clinical Study Site | Bucharest | |
Romania | Clinical Study Site | Iasi | |
Serbia | Clinical Study Site | Belgrade | |
Serbia | Clinical Study Site | Belgrade | |
Serbia | Clinical Study Site | Pancevo | |
Serbia | Clinical Study Site | Zrenjanin | |
Slovakia | Clinical Study Site | Bratislava | |
Slovakia | Clinical Study Site | Košice | |
Slovakia | Clinical Study Site | Prešov | |
Taiwan | Clinical Study Site | Changhua City | |
Taiwan | Clinical Study Site | Chiayi City | |
Taiwan | Clinical Study Site | New Taipei City | |
Taiwan | Clinical Study Site | Taichung | |
Taiwan | Clinical Study Site | Taipei | |
Taiwan | Clinical Study Site | Taipei | |
Taiwan | Clinical Study Site | Taipei | |
United States | Clinical Study Site | Austin | Texas |
United States | Clinical Study Site | Boston | Massachusetts |
United States | Clinical Study Site | Cedar Park | Texas |
United States | Clinical Study Site | Chapel Hill | North Carolina |
United States | Clinical Study Site | Freehold | New Jersey |
United States | Clinical Study Site | Greenville | South Carolina |
United States | Clinical Study Site | Houston | Texas |
United States | Clinical Study Site | Kissimmee | Florida |
United States | Clinical Study Site | Lancaster | California |
United States | Clinical Study Site | Los Angeles | California |
United States | Clinical Study Site | Mentor | Ohio |
United States | Clinical Study Site | Miami | Florida |
United States | Clinical Study Site | Miramar | Florida |
United States | Clinical Study Site | New Brunswick | New Jersey |
United States | Clinical Study Site | New York | New York |
United States | Clinical Study Site | Orlando | Florida |
United States | Clinical Study Site | Sun City | Arizona |
United States | Clinical Study Site | Wellington | Florida |
United States | Clinical Study Site | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Morphic Therapeutic, Inc |
United States, Australia, Austria, Bulgaria, Czechia, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS). | mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores. | From baseline to 12 weeks | |
Secondary | Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS) | mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores. | From baseline to 12 weeks |
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