A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
Recruiting · NCT07113522 · Interventional (participants receive a specific treatment) · Lead sponsor: Mirador Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
MT-201MT-501
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 20 US states.
- Mirador Therapeutics Selected Site - Birmingham, Alabama, United States
- Mirador Therapeutics Selected Site - Birmingham, Alabama, United States
- Mirador Therapeutics Selected Site - Scottsdale, Arizona, United States
- Mirador Therapeutics Selected Site - Scottsdale, Arizona, United States
- Mirador Therapeutics Selected Site - Sun City, Arizona, United States
- Mirador Therapeutics Selected Site - Sun City, Arizona, United States
- Mirador Therapeutics Selected Site - Little Rock, Arkansas, United States
- Mirador Therapeutics Selected Site - Little Rock, Arkansas, United States
- Mirador Therapeutics Selected Site - Little Rock, Arkansas, United States
- Mirador Therapeutics Selected Site - Little Rock, Arkansas, United States
- Mirador Therapeutics Selected Site - Colorado Springs, Colorado, United States
- Mirador Therapeutics Selected Site - Colorado Springs, Colorado, United States
- Mirador Therapeutics Selected Site - Littleton, Colorado, United States
- Mirador Therapeutics Selected Site - Littleton, Colorado, United States
- Mirador Therapeutics Selected Site - Miami, Florida, United States
- Mirador Therapeutics Selected Site - Miami, Florida, United States
- Mirador Therapeutics Selected Site - Miami, Florida, United States
- Mirador Therapeutics Selected Site - Miami, Florida, United States
- Mirador Therapeutics Selected Site - Miami, Florida, United States
- Mirador Therapeutics Selected Site - Miami, Florida, United States
- Mirador Therapeutics Selected Site - Orlando, Florida, United States
- Mirador Therapeutics Selected Site - Orlando, Florida, United States
- Mirador Therapeutics Selected Site - Palmetto Bay, Florida, United States
- Mirador Therapeutics Selected Site - Palmetto Bay, Florida, United States
- Mirador Therapeutics Selected Site - Pensacola, Florida, United States
- Mirador Therapeutics Selected Site - Pensacola, Florida, United States
- Mirador Therapeutics Selected Site - Atlanta, Georgia, United States
- Mirador Therapeutics Selected Site - Atlanta, Georgia, United States
- Mirador Therapeutics Selected Site - Snellville, Georgia, United States
- Mirador Therapeutics Selected Site - Snellville, Georgia, United States
- Mirador Therapeutics Selected Site - Glenview, Illinois, United States
- Mirador Therapeutics Selected Site - Glenview, Illinois, United States
- Mirador Therapeutics Selected Site - Gurnee, Illinois, United States
- Mirador Therapeutics Selected Site - Gurnee, Illinois, United States
- Mirador Therapeutics Selected Site - Lafayette, Louisiana, United States
- Mirador Therapeutics Selected Site - Lafayette, Louisiana, United States
- Mirador Therapeutics Selected Site - Marrero, Louisiana, United States
- Mirador Therapeutics Selected Site - Marrero, Louisiana, United States
- Mirador Therapeutics Selected Site - Shreveport, Louisiana, United States
- Mirador Therapeutics Selected Site - Shreveport, Louisiana, United States
- Mirador Therapeutics Selected Site - Ypsilanti, Michigan, United States
- Mirador Therapeutics Selected Site - Ypsilanti, Michigan, United States
- Mirador Therapeutics Selected Site - Bridgeton, Missouri, United States
- Mirador Therapeutics Selected Site - Bridgeton, Missouri, United States
- Mirador Therapeutics Selected Site - Kansas City, Missouri, United States
- Mirador Therapeutics Selected Site - Kansas City, Missouri, United States
- Mirador Therapeutics Selected Site - Liberty, Missouri, United States
- Mirador Therapeutics Selected Site - Liberty, Missouri, United States
- Mirador Therapeutics Selected Site - Las Vegas, Nevada, United States
- Mirador Therapeutics Selected Site - Las Vegas, Nevada, United States
- Mirador Therapeutics Selected Site - New York, New York, United States
- Mirador Therapeutics Selected Site - New York, New York, United States
- Mirador Therapeutics Selected Site - Rochester, New York, United States
- Mirador Therapeutics Selected Site - Rochester, New York, United States
- Mirador Therapeutics Selected Site - High Point, North Carolina, United States
- Mirador Therapeutics Selected Site - High Point, North Carolina, United States
- Mirador Therapeutics Selected Site - Raleigh, North Carolina, United States
- Mirador Therapeutics Selected Site - Raleigh, North Carolina, United States
- Mirador Therapeutics Selected Site - Cincinnati, Ohio, United States
- Mirador Therapeutics Selected Site - Cincinnati, Ohio, United States
Showing 60 of 132 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →