Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of MT-501 in patients with active Crohn's Disease or Ulcerative Colitis: A Phase 2 safety and effectiveness trial

Fast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study focuses on two inflammatory bowel conditions: Crohn's Disease and Ulcerative Colitis. These are long-term conditions that cause inflammation of the digestive system. The study will test a new medication called MT-501, which comes in the form of film-coated tablets taken by mouth. Some participants will receive MT-501, while others will receive a placebo.

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 conditions. The study is designed as a Phase 2 platform study, which means it will evaluate multiple treatment approaches for inflammatory bowel disease.

During the study, participants will go through an induction phase where they will take the study medication. Throughout this period, doctors will monitor how well the treatment works by examining the inside of the digestive tract and tracking symptoms. They will also check how the body processes the medication and look for any side effects that may occur. The study will collect information about improvements in the condition of the digestive tract lining and overall disease symptoms.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    The study focuses on participants with active Crohn's Disease or active Ulcerative Colitis

    You must be between 18 and 80 years old to participate

    Your condition must be classified as moderately to severely active

    Previous treatments with corticosteroids, immunosuppressants, or advanced therapy must have shown insufficient response

  2. Step 2

    Treatment phase (Induction Phase)

    You will receive either MT-501 or a placebo in the form of film-coated tablets

    The medication is taken orally

    The treatment period is called the Induction Phase

  3. Step 3

    Monitoring during treatment

    Your health will be monitored for any side effects or adverse reactions

    Laboratory tests will be conducted to check for any abnormal values

    For Crohn's Disease: Your endoscopic response will be evaluated

    For Ulcerative Colitis: Your endoscopic improvement will be assessed

  4. Step 4

    Final evaluation

    The doctor will assess if you have achieved clinical remission (reduction in disease symptoms)

    For Ulcerative Colitis: Additional tissue examination will be performed to check for improvement

    The effectiveness of the treatment will be measured through specific disease activity scores

    The study is expected to continue until May 2027

Who can join the trial?

15 criteria

  • Age between 18 and 80 years old
  • Must be able to provide written informed consent and understand study requirements
  • For Ulcerative Colitis patients:
    • Must have confirmed diagnosis of Ulcerative Colitis
    • Must have moderate to severe disease activity
    • Must meet medication stability requirements
    • For Crohn's Disease patients:
      • Must have confirmed diagnosis of Crohn's Disease
      • Must have moderate to severe disease activity (measured by CDAI - a disease activity score)
      • Must have moderate to severe disease confirmed by endoscopy (SES-CD score)
      • Must meet medication stability requirements
      • Must have had inadequate response or side effects to previous treatments, including:
        • Corticosteroids (anti-inflammatory medications)
        • Immunosuppressants (medications that reduce immune system activity)
        • Advanced therapies
        • For female participants:
          • Must either be unable to bear children, or
          • Must have a negative pregnancy test during screening
          • Must follow specific birth control requirements during the study

Who cannot join the trial?

14 criteria

  • History of cancer or pre-cancerous conditions within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Current severe infections, including active tuberculosis or hepatitis B
  • History of major surgery related to the digestive system in the past 6 months
  • Pregnant or breastfeeding women, or those planning pregnancy during the study period
  • Participation in another clinical trial within the past 30 days
  • Known allergic reactions to similar medications
  • Significant heart, liver, or kidney disease that could interfere with the study
  • Current use of medications that could interact with the study drug
  • Mental health conditions that could affect the ability to follow study procedures
  • History of substance abuse within the past year
  • Unstable or poorly controlled diabetes
  • Blood disorders that could increase risk of complications
  • Unable to undergo required medical procedures or testing
  • History of not following medical treatment plans
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Based on the provided data, I cannot extract specific medications or therapies as they are not included in the source data. The trial appears to be a Phase 2 platform study for multiple therapies in Crohn's Disease and Ulcerative Colitis patients, but the specific medications are not listed in the provided information. If you would like a list of medications and their descriptions, please provide additional data that includes the specific treatments being studied in this clinical trial.

What is already known about the treatment

Since no specific medication names are provided in the source data, I cannot create medication descriptions in the requested format. The data only shows that this is a Phase 2 platform study examining multiple therapies for Ulcerative Colitis and Crohn's Disease, but does not specify which medications are being tested. If you would like medication descriptions, please provide the specific medication names that are being tested in this clinical trial.

Investigated diseases

  • Ulcerative Colitis

    A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and ulcers in the digestive tract's innermost lining. It develops gradually and can cause ongoing symptoms including diarrhea with blood or mucus, abdominal pain, and urgency to have bowel movements. The inflammation typically starts in the rectum and can spread continuously to other parts of the colon.

  • Crohn's Disease

    A chronic inflammatory bowel disease that can affect any part of the digestive tract, from the mouth to the anus. Unlike ulcerative colitis, Crohn's disease involves inflammation that can spread deep into affected tissues and can occur in patches, with healthy tissue between affected areas. The condition commonly affects the end of the small intestine and the beginning of the colon. Common symptoms include abdominal pain, diarrhea, fatigue, and reduced appetite.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522001-38-00Protocol codeMT-100-201Estimated enrolment55 patientsSponsorMirador Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.