Phase 2 testing of new therapies for moderate-to-severe inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, multicenter platform study enrolling adults with moderately to severely active Crohn's disease or ulcerative colitis to test multiple investigational oral or parenteral therapies. Participants must have diagnosis confirmed by endoscopy and histopathology and meet disease-activity thresholds (CDAI and SES-CD for Crohn's; a 3-component MMCS for UC) along with protocol drug-stabilization requirements. The trial will collect safety, efficacy, pharmacokinetic, and pharmacodynamic data across treatment arms including MT-501 and MT-201. Mirador Therapeutics sponsors the study with initial sites in Birmingham, Alabama and Scottsdale/Sun City, Arizona.

Why it matters

Who can join: the full rules

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's running

• Mirador Therapeutics Selected Site
  Birmingham, Alabama, United States Recruiting
• Mirador Therapeutics Selected Site
  Scottsdale, Arizona, United States Recruiting
• Mirador Therapeutics Selected Site
  Sun City, Arizona, United States Recruiting
• Mirador Therapeutics Selected Site
  Little Rock, Arkansas, United States Recruiting
• Mirador Therapeutics Selected Site
  Little Rock, Arkansas, United States Recruiting
• Mirador Therapeutics Selected Site
  Colorado Springs, Colorado, United States Recruiting

+16 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: ASCEND-IBD Trial Center
• Email: clinicaltrials@miradortx.com
• Phone: 844-206-4980

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.