A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
Purpose
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.
Conditions
- Inflammatory Bowel Disease (IBD)
- Ulcerative Colitis (UC)
- Crohn's Disease
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Prospective Observer-Blinded Endpoint
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Specific Appendix- Crohn's Disease |
Participants will receive MT-501 Tablets |
|
|
Experimental Intervention Specific Appendix- Ulcerative Colitis |
Participants will receive MT-501Tablets |
|
|
Experimental Intervention Specific Appendix- Crohn's Disease with Standard of Care |
Participants will receive multiple intravenous doses of MT-201 with standard of care |
|
Recruiting Locations
Mirador Therapeutics Selected Site
Birmingham, Alabama 35235
Birmingham, Alabama 35235
Mirador Therapeutics Selected Site
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Mirador Therapeutics Selected Site
Sun City, Arizona 85351
Sun City, Arizona 85351
Mirador Therapeutics Selected Site
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Mirador Therapeutics Selected Site
Little Rock, Arkansas 72211
Little Rock, Arkansas 72211
Mirador Therapeutics Selected Site
Colorado Springs, Colorado 80921
Colorado Springs, Colorado 80921
Mirador Therapeutics Selected Site
Littleton, Colorado 80120
Littleton, Colorado 80120
Mirador Therapeutics Selected Site
Miami, Florida 33134
Miami, Florida 33134
Mirador Therapeutics Selected Site
Miami, Florida 33165
Miami, Florida 33165
Mirador Therapeutics Selected Site
Miami, Florida 33176
Miami, Florida 33176
Mirador Therapeutics Selected Site
Orlando, Florida 32825
Orlando, Florida 32825
Mirador Therapeutics Selected Site
Palmetto Bay, Florida 33176
Palmetto Bay, Florida 33176
Mirador Therapeutics Selected Site
Pensacola, Florida 32504
Pensacola, Florida 32504
Mirador Therapeutics Selected Site
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Mirador Therapeutics Selected Site
Snellville, Georgia 30078
Snellville, Georgia 30078
Mirador Therapeutics Selected Site
Glenview, Illinois 60026
Glenview, Illinois 60026
Mirador Therapeutics Selected Site
Gurnee, Illinois 60031
Gurnee, Illinois 60031
Mirador Therapeutics Selected Site
Lafayette, Louisiana 70503
Lafayette, Louisiana 70503
Mirador Therapeutics Selected Site
Marrero, Louisiana 70072
Marrero, Louisiana 70072
Mirador Therapeutics Selected Site
Shreveport, Louisiana 71105
Shreveport, Louisiana 71105
Mirador Therapeutics Selected Site
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Mirador Therapeutics Selected Site
Bridgeton, Missouri 63044
Bridgeton, Missouri 63044
Mirador Therapeutics Selected Site
Kansas City, Missouri 64114
Kansas City, Missouri 64114
Mirador Therapeutics Selected Site
Liberty, Missouri 64068
Liberty, Missouri 64068
Mirador Therapeutics Selected Site
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Mirador Therapeutics Selected Site
New York, New York 10016
New York, New York 10016
Mirador Therapeutics Selected Site
Rochester, New York 14618
Rochester, New York 14618
Mirador Therapeutics Selected Site
High Point, North Carolina 27262
High Point, North Carolina 27262
Mirador Therapeutics Selected Site
Raleigh, North Carolina 27612
Raleigh, North Carolina 27612
Mirador Therapeutics Selected Site
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Mirador Therapeutics Selected Site
Liberty Township, Ohio 45044
Liberty Township, Ohio 45044
Mirador Therapeutics Selected Site
Providence, Rhode Island 02904
Providence, Rhode Island 02904
Mirador Therapeutics Selected Site
Greenville, South Carolina 29607
Greenville, South Carolina 29607
Mirador Therapeutics Selected Site
Cordova, Tennessee 38018
Cordova, Tennessee 38018
Mirador Therapeutics Selected Site
Dallas, Texas 75230
Dallas, Texas 75230
Mirador Therapeutics Selected Site
Garland, Texas 75044
Garland, Texas 75044
Mirador Therapeutics Selected Site
Georgetown, Texas 78628
Georgetown, Texas 78628
Mirador Therapeutics Selected Site
Houston, Texas 77090
Houston, Texas 77090
Mirador Therapeutics Selected Site
Lubbock, Texas 79424
Lubbock, Texas 79424
Mirador Therapeutics Selected Site
Southlake, Texas 76092
Southlake, Texas 76092
Mirador Therapeutics Selected Site
Tyler, Texas 75701
Tyler, Texas 75701
Mirador Therapeutics Selected Site
Webster, Texas 77598
Webster, Texas 77598
Mirador Therapeutics Selected Site
Bellevue, Washington 98004
Bellevue, Washington 98004
Mirador Therapeutics Selected Site
Silverdale, Washington 98383
Silverdale, Washington 98383
Mirador Therapeutics Selected Site
Tacoma, Washington 98405
Tacoma, Washington 98405
Mirador Therapeutics Selected Site
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
More Details
- Status
- Recruiting
- Sponsor
- Mirador Therapeutics, Inc.
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.