A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

NCT ID: NCT07113522

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-26

Study Completion Date

2027-05-07

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Prospective Observer-Blinded Endpoint

Study Groups

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Intervention Specific Appendix- Crohn's Disease

Participants will receive MT-501

Group Type EXPERIMENTAL

MT-501

Intervention Type DRUG

MT-501 Tablets

Intervention Specific Appendix- Ulcerative Colitis

Participants will receive MT-501

Group Type EXPERIMENTAL

MT-501

Intervention Type DRUG

MT-501 Tablets

Interventions

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MT-501

MT-501 Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mirador Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mirador Therapeutics Selected Site

Little Rock, Arkansas, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Miami, Florida, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Orlando, Florida, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Snellville, Georgia, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Glenview, Illinois, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Shreveport, Louisiana, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Liberty, Missouri, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Rochester, New York, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Greenville, South Carolina, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Cordova, Tennessee, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Dallas, Texas, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Georgetown, Texas, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Lubbock, Texas, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Southlake, Texas, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Tyler, Texas, United States

Site Status RECRUITING

Mirador Therapeutics Selected Site

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ASCEND-IBD Trial Center

Role: CONTACT

844-206-4980

Facility Contacts

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ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

ASCEND-IBD Trial Center

Role: primary

844-206-4980

Other Identifiers

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MT-100-201

Identifier Type: -

Identifier Source: org_study_id

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