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NCT07113522PHASE2Recruiting

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Mirador Therapeutics, Inc.

Start Date

6/26/2025

Completion Date

2/4/2028

Summary

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.

Detailed Description

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

Age Range: 18 years to 80 years

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

Interventions

DRUG

MT-501

DRUG

MT-201

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Conditions

Inflammatory Bowel Disease (IBD)Ulcerative Colitis (UC)Crohn's Disease

Locations

Mirador Therapeutics Selected Site

Birmingham, Alabama 35235

United States

Mirador Therapeutics Selected Site

Scottsdale, Arizona 85258

United States

Mirador Therapeutics Selected Site

Sun City, Arizona 85351

United States

Mirador Therapeutics Selected Site

Little Rock, Arkansas 72205

United States

Mirador Therapeutics Selected Site

Little Rock, Arkansas 72211

United States

Mirador Therapeutics Selected Site

Colorado Springs, Colorado 80921

United States

Mirador Therapeutics Selected Site

Littleton, Colorado 80120

United States

Mirador Therapeutics Selected Site

Miami, Florida 33134

United States

Mirador Therapeutics Selected Site

Miami, Florida 33165

United States

Mirador Therapeutics Selected Site

Miami, Florida 33176

United States

Mirador Therapeutics Selected Site

Orlando, Florida 32825

United States

Mirador Therapeutics Selected Site

Palmetto Bay, Florida 33176

United States

Mirador Therapeutics Selected Site

Pensacola, Florida 32504

United States

Mirador Therapeutics Selected Site

Atlanta, Georgia 30342

United States

Mirador Therapeutics Selected Site

Snellville, Georgia 30078

United States

Mirador Therapeutics Selected Site

Glenview, Illinois 60026

United States

Mirador Therapeutics Selected Site

Gurnee, Illinois 60031

United States

Mirador Therapeutics Selected Site

Lafayette, Louisiana 70503

United States

Mirador Therapeutics Selected Site

Marrero, Louisiana 70072

United States

Mirador Therapeutics Selected Site

Shreveport, Louisiana 71105

United States

Mirador Therapeutics Selected Site

Ypsilanti, Michigan 48197

United States

Mirador Therapeutics Selected Site

Bridgeton, Missouri 63044

United States

Mirador Therapeutics Selected Site

Kansas City, Missouri 64114

United States

Mirador Therapeutics Selected Site

Liberty, Missouri 64068

United States

Mirador Therapeutics Selected Site

Las Vegas, Nevada 89128

United States

Mirador Therapeutics Selected Site

New York, New York 10016

United States

Mirador Therapeutics Selected Site

Rochester, New York 14618

United States

Mirador Therapeutics Selected Site

High Point, North Carolina 27262

United States

Mirador Therapeutics Selected Site

Raleigh, North Carolina 27612

United States

Mirador Therapeutics Selected Site

Cincinnati, Ohio 45219

United States

Mirador Therapeutics Selected Site

Liberty Township, Ohio 45044

United States

Mirador Therapeutics Selected Site

Providence, Rhode Island 02904

United States

Mirador Therapeutics Selected Site

Greenville, South Carolina 29607

United States

Mirador Therapeutics Selected Site

Cordova, Tennessee 38018

United States

Mirador Therapeutics Selected Site

Dallas, Texas 75230

United States

Mirador Therapeutics Selected Site

Garland, Texas 75044

United States

Mirador Therapeutics Selected Site

Georgetown, Texas 78628

United States

Mirador Therapeutics Selected Site

Houston, Texas 77090

United States

Mirador Therapeutics Selected Site

Lubbock, Texas 79424

United States

Mirador Therapeutics Selected Site

Southlake, Texas 76092

United States

Mirador Therapeutics Selected Site

Tyler, Texas 75701

United States

Mirador Therapeutics Selected Site

Webster, Texas 77598

United States

Mirador Therapeutics Selected Site

Bellevue, Washington 98004

United States

Mirador Therapeutics Selected Site

Silverdale, Washington 98383

United States

Mirador Therapeutics Selected Site

Tacoma, Washington 98405

United States

Mirador Therapeutics Selected Site

Milwaukee, Wisconsin 53215

United States

Mirador Therapeutics Selected Site

Toronto,

Canada

Mirador Therapeutics Selected Site

Kutaisi,

Georgia

Mirador Therapeutics Selected Site

Marneuli,

Georgia

Mirador Therapeutics Selected Site

Tbilisi, 0102

Georgia

Mirador Therapeutics Selected Site

Tbilisi, 0144

Georgia

Mirador Therapeutics Selected Site

Tbilisi, 0159

Georgia

Mirador Therapeutics Selected Site

Tbilisi, 0178

Georgia

Mirador Therapeutics Selected Site

Tbilisi, 0180

Georgia

Mirador Therapeutics Selected Site

Tbilisi, 4600

Georgia

Mirador Therapeutics Selected Site

Chisinau,

Moldova

Mirador Therapeutics Selected Site

Chisinau,

Moldova

Mirador Therapeutics Selected Site

Ivano-Frankivsk,

Ukraine

Mirador Therapeutics Selected Site

Kyiv, 02002

Ukraine

Mirador Therapeutics Selected Site

Kyiv, 02091

Ukraine

Mirador Therapeutics Selected Site

Kyiv, 03037

Ukraine

Mirador Therapeutics Selected Site

Kyiv,

Ukraine

Mirador Therapeutics Selected Site

Lutsk,

Ukraine

Mirador Therapeutics Selected Site

Lviv,

Ukraine

Mirador Therapeutics Selected Site

Poltava,

Ukraine

Mirador Therapeutics Selected Site

Vinnytsia,

Ukraine