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RECRUITINGPhase 2INTERVENTIONAL

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

MT-501

MT-501

DRUG

MT-201

MT-201

Locations (20)

Mirador Therapeutics Selected Site
Birmingham, Alabama, United States
Mirador Therapeutics Selected Site
Scottsdale, 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
Colorado Springs, 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
Orlando, Florida, United States
Mirador Therapeutics Selected Site
Palmetto Bay, Florida, United States
Mirador Therapeutics Selected Site
Pensacola, Florida, United States
Mirador Therapeutics Selected Site
Atlanta, Georgia, United States
Mirador Therapeutics Selected Site
Snellville, Georgia, United States
Mirador Therapeutics Selected Site
Glenview, Illinois, United States
Mirador Therapeutics Selected Site
Gurnee, Illinois, United States
Mirador Therapeutics Selected Site
Lafayette, Louisiana, United States
Mirador Therapeutics Selected Site
Marrero, Louisiana, United States
Mirador Therapeutics Selected Site
Shreveport, Louisiana, United States