A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
NCT ID: NCT07113522
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-06-26
2027-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Intervention Specific Appendix- Crohn's Disease
Participants will receive MT-501
MT-501
MT-501 Tablets
Intervention Specific Appendix- Ulcerative Colitis
Participants will receive MT-501
MT-501
MT-501 Tablets
Interventions
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MT-501
MT-501 Tablets
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Mirador Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Mirador Therapeutics Selected Site
Little Rock, Arkansas, United States
Mirador Therapeutics Selected Site
Miami, Florida, United States
Mirador Therapeutics Selected Site
Orlando, Florida, United States
Mirador Therapeutics Selected Site
Snellville, Georgia, United States
Mirador Therapeutics Selected Site
Glenview, Illinois, United States
Mirador Therapeutics Selected Site
Shreveport, Louisiana, United States
Mirador Therapeutics Selected Site
Liberty, Missouri, United States
Mirador Therapeutics Selected Site
Rochester, New York, United States
Mirador Therapeutics Selected Site
Greenville, South Carolina, United States
Mirador Therapeutics Selected Site
Cordova, Tennessee, United States
Mirador Therapeutics Selected Site
Dallas, Texas, United States
Mirador Therapeutics Selected Site
Georgetown, Texas, United States
Mirador Therapeutics Selected Site
Lubbock, Texas, United States
Mirador Therapeutics Selected Site
Southlake, Texas, United States
Mirador Therapeutics Selected Site
Tyler, Texas, United States
Mirador Therapeutics Selected Site
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MT-100-201
Identifier Type: -
Identifier Source: org_study_id
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