What is MT-501 studying for Inflammatory Bowel Disease?

MT-501 is being studied in adults with moderately to severely active Crohn's Disease or Ulcerative Colitis to evaluate its safety, effectiveness, and how it affects the disease. The research aims to find out if MT-501 can help manage symptoms and improve intestinal health. This study is sponsored by Mirador Therapeutics, Inc.

Who may be eligible for this Inflammatory Bowel Disease clinical trial?

Adults aged 18 to 80 with a confirmed diagnosis of moderately to severely active Crohn's Disease or Ulcerative Colitis may be eligible. Participants should meet specific disease activity and drug stabilization criteria and not have certain recent surgeries or infections. Please review eligibility criteria for more details.

Is there any cost to participate in this Inflammatory Bowel Disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years - 80Years

All Genders

ID07113522

A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics With Multiple Therapies in Participants With Active Crohn's Disease or Active Ulcerative Colitis (ASCEND-IBD)

Led by Mirador Therapeutics, Inc. · Updated on 2026-03-12

140

Participants Needed

Research Sites

40 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating multiple investigational therapies in adult participants with moderately to severely active Crohn's Disease or Ulcerative Colitis, which are types of Inflammatory Bowel Disease (IBD). This Phase 2 platform study aims to assess the safety, effectiveness, how the body processes the drugs, and their effects on the disease. The study is sponsored by Mirador Therapeutics, Inc. and is designed to explore several oral or intravenous experimental treatments. Participants will be assigned to receive one of several treatments including MT-501 tablets or multiple intravenous doses of MT-201 combined with standard care. Different groups will receive these therapies to compare their effects. The treatment period lasts up to 13 weeks, during which participants will be closely monitored for responses and side effects. During the study, participants will undergo assessments including endoscopy and clinical evaluations to measure disease activity and response. Laboratory tests will monitor safety, and pharmacokinetics will track how the drugs are absorbed and processed. Researchers will observe treatment side effects and disease improvement using specific clinical and endoscopic measures over 12 to 13 weeks. The total participation duration corresponds to the treatment and monitoring period outlined.

CONDITIONS

Brief Title

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 80 years
Diagnosis of Crohn's Disease confirmed by endoscopy and histopathology
Moderately to severely active Crohn's Disease defined by Clinical Disease Activity Index and Simple Endoscopic Score
Meets drug stabilization requirements for Crohn's Disease
Diagnosis of Ulcerative Colitis confirmed by endoscopy and histopathology
Moderately to severely active Ulcerative Colitis defined by a 3-component MMCS
Meets drug stabilization requirements for Ulcerative Colitis

You will not qualify if you...

Diagnosis of indeterminate colitis
Suspected or diagnosed intra-abdominal or perianal abscess at screening
Previous small bowel resection with combined resected length of more than 100 cm
Previous colonic resection of more than 2 segments
Crohn's Disease isolated to stomach, duodenum, jejunum, or perianal region without colonic or ileal involvement
Current or recent (within 6 months) fulminant colitis, toxic megacolon, or bowel perforation
Current stoma or planned colostomy or ileostomy
Received intravenous corticosteroids within 14 days prior to screening or during screening phase
Previous total proctocolectomy or subtotal colectomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 13 weeks

Participants receive multiple oral or intravenous experimental therapies for moderately to severely active Crohn's Disease or Ulcerative Colitis to evaluate safety and efficacy.

Regular visits during treatment for assessments