A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics With Multiple Therapies in Participants With Active Crohn's Disease or Active Ulcerative Colitis (ASCEND-IBD)
Status: Recruiting
Location: See all (66) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology
• Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD)
• Meets drug stabilization requirements
• Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology
• Moderately to severely active UC as defined by a 3-component MMCS
• Meets drug stabilization requirements
Locations
United States
Alabama
Mirador Therapeutics Selected Site
RECRUITING
Birmingham
Arkansas
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Little Rock
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Little Rock
Arizona
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Scottsdale
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Sun City
Colorado
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Colorado Springs
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Littleton
Florida
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Miami
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Miami
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Miami
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Orlando
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Palmetto Bay
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Pensacola
Georgia
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Atlanta
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Snellville
Illinois
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Glenview
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Gurnee
Louisiana
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Lafayette
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Marrero
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Shreveport
Michigan
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Ypsilanti
Missouri
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Bridgeton
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Kansas City
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Liberty
North Carolina
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High Point
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Raleigh
Nevada
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Las Vegas
New York
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New York
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Rochester
Ohio
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Cincinnati
Mirador Therapeutics Selected Site
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Liberty Township
Rhode Island
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Providence
South Carolina
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Greenville
Tennessee
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Cordova
Texas
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Dallas
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Garland
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Georgetown
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Houston
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Lubbock
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Southlake
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Tyler
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Webster
Washington
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Bellevue
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Silverdale
Mirador Therapeutics Selected Site
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Tacoma
Wisconsin
Mirador Therapeutics Selected Site
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Milwaukee
Other Locations
Canada
Mirador Therapeutics Selected Site
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Toronto
Georgia
Mirador Therapeutics Selected Site
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Kutaisi
Mirador Therapeutics Selected Site
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Marneuli
Mirador Therapeutics Selected Site
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Tbilisi
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Tbilisi
Mirador Therapeutics Selected Site
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Tbilisi
Mirador Therapeutics Selected Site
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Tbilisi
Mirador Therapeutics Selected Site
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Tbilisi
Mirador Therapeutics Selected Site
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Tbilisi
Republic of Moldova
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Chisinau
Mirador Therapeutics Selected Site
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Chisinau
Ukraine
Mirador Therapeutics Selected Site
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Ivano-frankivsk
Mirador Therapeutics Selected Site
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Kyiv
Mirador Therapeutics Selected Site
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Kyiv
Mirador Therapeutics Selected Site
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Kyiv
Mirador Therapeutics Selected Site
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Kyiv
Mirador Therapeutics Selected Site
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Lutsk
Mirador Therapeutics Selected Site
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Lviv
Mirador Therapeutics Selected Site
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Poltava
Mirador Therapeutics Selected Site
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Vinnytsia
Contact Information
Primary
ASCEND-IBD Trial Center
clinicaltrials@miradortx.com
844-206-4980
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2028-02-04
Participants
Target number of participants: 140
Treatments
Experimental: Intervention Specific Appendix- Crohn's Disease
Participants will receive MT-501 Tablets
Experimental: Intervention Specific Appendix- Ulcerative Colitis
Participants will receive MT-501Tablets
Experimental: Intervention Specific Appendix- Crohn's Disease with Standard of Care
Participants will receive multiple intravenous doses of MT-201 with standard of care
Related Therapeutic Areas
Sponsors
Leads: Mirador Therapeutics, Inc.