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Phase 2 Study for Inflammatory Bowel Disease (IBD)

This study is testing two investigational drugs, MT-501 and MT-201, for adults with moderately to severely active Crohn's Disease or Ulcerative Colitis (types of Inflammatory Bowel Disease or IBD). Researchers want to see how safe and effective these drugs are. To join, you must be between 18 and 80 years old and have a confirmed diagnosis of Crohn's Disease or Ulcerative Colitis. Success in this study will be measured by how many participants experience side effects, and how well the drugs improve the disease as seen during endoscopy (a procedure to look inside the body). This study plans to enroll 140 participants, but its current recruitment status is unclear.

Study design
This is a Phase 2 study, meaning it's an early-stage study to evaluate new treatments. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess outcomes up to 13 weeks for Crohn's Disease and 12 weeks for Ulcerative Colitis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07113522

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Mirador Therapeutics, Inc.
~140 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:MT-501MT-201

At a glance

Recruiting sites
66 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values
Measured over Up to 13 weeks
+4 more outcomes measured

Conditions

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

Explore related trials

Crohn DiseaseInflammatory Bowel DiseaseUlcerative Colitis

Where it's being run

66 sites across 23 states
Georgia10
Ukraine9
Texas8
Florida6
Louisiana3
Missouri3
Washington3
Arizona2

Who to contact

ASCEND-IBD Trial Center
[email protected]
844-206-4980
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory valuesUp to 13 weeks
  • Assess the Proportion of Participants with Endoscopic Response (CD)13 weeks

    Endoscopic response as assessed by SES-CD score.

  • Assess the Proportion of Participants Endoscopic Improvement (UC)12 weeks

    Endoscopic improvement as assessed by MES.

  • Assess the Proportion of Participants with Clinical Remission (CD)13 weeks

    Clinical remission as assessed by CDAI score.

  • Assess the Proportion of Participants with Clinical Remission (UC)12 weeks

    Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.