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A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
NCT07113522 · Mirador Therapeutics, Inc.
In plain English
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Official title
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)
About this study
The purpose of this platform study is to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) to evaluate multiple oral or parenteral experimental therapies for moderately to severely active Crohn's Disease or Ulcerative Colitis.
Eligibility criteria
Inclusion Criteria-Crohn's Disease:
* 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
Inclusion Criteria-Ulcerative Colitis:
* 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
Exclusion Criteria-Crohn's Disease:
* Diagnosis of indeterminate colitis
* Suspected or diagnosed intra-abdominal or perianal abscess at Screening
* Previous small bowel resection with combined resected length of \> 100 cm or previous colonic resection of \> 2 segments
* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
Exclusion Criteria-Ulcerative Colitis:
* Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
* Current stoma or impending need for colostomy or ileostomy
* Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase
* Previous total proctocolectomy or subtotal colectomy
Study design
Enrollment target: 140 participants
Allocation: na
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-06-26
Estimated completion: 2028-02-04
Last updated: 2026-03-12
Interventions
Drug: MT-501Drug: MT-201
Primary outcomes
- • Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values (Up to 13 weeks)
- • Assess the Proportion of Participants with Endoscopic Response (CD) (13 weeks)
- • Assess the Proportion of Participants Endoscopic Improvement (UC) (12 weeks)
Sponsor
Mirador Therapeutics, Inc. · industry
Contacts & investigators
ContactASCEND-IBD Trial Center · contact · clinicaltrials@miradortx.com · 844-206-4980
All locations (66)
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Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Sun City, Arizona, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Colorado Springs, Colorado, United States
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Littleton, Colorado, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palmetto Bay, Florida, United States
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Pensacola, Florida, United States
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Atlanta, Georgia, United States
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Snellville, Georgia, United States
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Glenview, Illinois, United States
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Gurnee, Illinois, United States
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Lafayette, Louisiana, United States
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Marrero, Louisiana, United States
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Shreveport, Louisiana, United States
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Ypsilanti, Michigan, United States
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Bridgeton, Missouri, United States
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Kansas City, Missouri, United States
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Liberty, Missouri, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Rochester, New York, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Liberty Township, Ohio, United States
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Providence, Rhode Island, United States
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Greenville, South Carolina, United States
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Cordova, Tennessee, United States
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Dallas, Texas, United States
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Garland, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Southlake, Texas, United States
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Tyler, Texas, United States
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Webster, Texas, United States
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Bellevue, Washington, United States
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Silverdale, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Toronto, Canada
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Kutaisi, Georgia
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Marneuli, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Chisinau, Moldova
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Chisinau, Moldova
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Ivano-Frankivsk, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Poltava, Ukraine
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Vinnytsia, Ukraine