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 (16) 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
Arkansas
Mirador Therapeutics Selected Site
RECRUITING
Little Rock
Florida
Mirador Therapeutics Selected Site
RECRUITING
Miami
Mirador Therapeutics Selected Site
RECRUITING
Orlando
Georgia
Mirador Therapeutics Selected Site
RECRUITING
Snellville
Illinois
Mirador Therapeutics Selected Site
RECRUITING
Glenview
Louisiana
Mirador Therapeutics Selected Site
RECRUITING
Shreveport
Missouri
Mirador Therapeutics Selected Site
RECRUITING
Liberty
New York
Mirador Therapeutics Selected Site
RECRUITING
Rochester
South Carolina
Mirador Therapeutics Selected Site
RECRUITING
Greenville
Tennessee
Mirador Therapeutics Selected Site
RECRUITING
Cordova
Texas
Mirador Therapeutics Selected Site
RECRUITING
Dallas
Mirador Therapeutics Selected Site
RECRUITING
Georgetown
Mirador Therapeutics Selected Site
RECRUITING
Lubbock
Mirador Therapeutics Selected Site
RECRUITING
Southlake
Mirador Therapeutics Selected Site
RECRUITING
Tyler
Wisconsin
Mirador Therapeutics Selected Site
RECRUITING
Milwaukee
Contact Information
Primary
ASCEND-IBD Trial Center
clinicaltrials@miradortx.com
844-206-4980
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2027-05-07
Participants
Target number of participants: 90
Treatments
Experimental: Intervention Specific Appendix- Crohn's Disease
Participants will receive MT-501
Experimental: Intervention Specific Appendix- Ulcerative Colitis
Participants will receive MT-501
Related Therapeutic Areas
Sponsors
Leads: Mirador Therapeutics, Inc.