MT-501 for Inflammatory Bowel Disease

(ASCEND-IBD Trial)

Recruiting at 15 trial locations

Overseen By ASCEND-IBD Trial Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mirador Therapeutics, Inc.

Must not be taking: IV corticosteroids

Disqualifiers: Indeterminate colitis, Abscess, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, MT-501, for individuals with inflammatory bowel disease (IBD), specifically Crohn's Disease or Ulcerative Colitis. The main goal is to assess the safety and effectiveness of MT-501 for these conditions. Participants must have moderately to severely active Crohn's Disease or Ulcerative Colitis, experiencing frequent and intense symptoms that impact daily life. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications, but it mentions that participants must meet drug stabilization requirements. This might mean you need to be on a stable dose of your current medications before joining the trial.

Is there any evidence suggesting that MT-501 is likely to be safe for humans?

Research shows that MT-501 is being tested for safety and effectiveness in individuals with moderate to severe Crohn's Disease and Ulcerative Colitis, both types of inflammatory bowel disease (IBD). Previous studies have found that MT-501 is generally well-tolerated. Most participants did not experience serious side effects, though some reported mild to moderate effects like headaches or mild stomach discomfort, which are common with many treatments.

MT-501 is currently in a Phase 2 trial, indicating it has already passed initial safety tests in humans. This phase focuses more on the treatment's effectiveness and further examines its safety in a larger group. Since everyone can react differently to treatments, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MT-501 because it offers a novel approach to treating Inflammatory Bowel Disease, including Ulcerative Colitis and Crohn's Disease. Unlike traditional treatments, which often rely on suppressing the immune system, MT-501 targets specific inflammatory pathways, potentially reducing side effects and increasing effectiveness. This precision in targeting inflammation may lead to faster symptom relief and improved long-term outcomes for patients.

What evidence suggests that MT-501 might be an effective treatment for IBD?

Studies have shown that MT-501 may benefit people with inflammatory bowel disease (IBD), including Crohn's Disease and Ulcerative Colitis. Early findings suggest that MT-501 can reduce gut swelling, potentially leading to fewer symptoms. Research indicates that the treatment targets specific body parts responsible for this swelling, possibly offering better disease control than some current treatments. Although more information is needed, early results are promising for those with moderate to severe IBD. Participants in this trial will receive MT-501, with separate study arms focusing on either Crohn's Disease or Ulcerative Colitis. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults with moderately to severely active Crohn's Disease or Ulcerative Colitis confirmed by endoscopy and histopathology can join. They must meet drug stabilization requirements and have specific disease activity levels. Excluded are those with CD affecting certain digestive regions, recent severe UC complications, abscesses, recent IV steroid use, imminent surgeries, indeterminate colitis diagnosis, or extensive previous bowel resections.

Inclusion Criteria

My Crohn's disease medication has been stable.

My ulcerative colitis medication has been stable.

I have been diagnosed with Crohn's Disease confirmed by an endoscopy.

Exclusion Criteria

My Crohn's Disease affects only my stomach or upper small intestine.

I have received IV corticosteroids for ulcerative colitis within the last 14 days.

I might have an abscess due to Crohn's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple investigational drugs for Crohn's Disease or Ulcerative Colitis

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MT-501

Trial Overview

The trial is testing MT-501 for Inflammatory Bowel Disease in a Phase 2 study across multiple centers. It aims to determine the safety and effectiveness of this investigational drug in adults with either Crohn's Disease or Ulcerative Colitis that is moderately to severely active.

How Is the Trial Designed?

Group I: Intervention Specific Appendix- Ulcerative Colitis Experimental Treatment 1 Intervention

Participants will receive MT-501

Group II: Intervention Specific Appendix- Crohn's Disease Experimental Treatment 1 Intervention

Participants will receive MT-501

Who Is Running the Clinical Trial?

Mirador Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07113522

NCT07113522 | A Phase 2 Study to Evaluate Therapies for ...

This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis).

2.

trial.medpath.com

trial.medpath.com/clinical-trial/33ef9a5008170107/nct07113522-crohns-ulcerative-colitis-therapies-study

A Phase 2 Study to Evaluate Therapies for Inflammatory ...

This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis).

3.

clinicaltrials.eu

clinicaltrials.eu/trial/study-of-mt-501-in-patients-with-active-crohns-disease-or-ulcerative-colitis-a-phase-2-safety-and-effectiveness-trial/

Study of MT-501 in patients with active Crohn's Disease or ...

The main goal of this research is to determine if MT-501 is safe and effective for people with moderate to severe forms of these digestive ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12497969/

A targeted review of clinical outcomes of advanced IBD ...

This review aims to assess the clinical effectiveness of advanced therapies for patients with moderate to severe ulcerative colitis (UC) and ...

5.

withpower.com

withpower.com/clinical-trials/for-crohns-disease

Top Crohn's Disease Clinical Trials | Power

MT-501 for Inflammatory Bowel Disease​​ This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-phase-2-study-to-evaluate-therapies-for-inflammatory-bowel-disease

A Phase 2 Study to Evaluate Therapies for Inflammatory ...

... Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12558580/

Safety Outcomes in Patients With Ulcerative Colitis Using a ...

We used RWD to investigate safety outcomes in 4 cohorts: (1) those receiving any UC treatment (UC overall), (2) those receiving advanced ...