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MB-001

Clinical trials are studying MB-001 in adults with moderate to severe ulcerative colitis. These trials aim to check safety, tolerability, and signs of benefit. The main focus is whether MB-001 can help people with active disease reach remission.

Table of Contents

Trial overview

The clinical trial with ID 2025-524719-35-00 is a study of MB-001 in adults with moderate to severe ulcerative colitis.[1] It is an interventional study, which means researchers give a treatment and then measure the results.[1] The study is authorised and plans to enroll 100 participants.[1]

Who can participate

The trial is for adults with moderately to severely active ulcerative colitis.[1] The source data do not list more detailed entry rules, so the available information only confirms the condition, age group, and disease activity level.[1]

What is being measured

The main safety measures include the number of adverse events, treatment-emergent adverse events, serious adverse events, adverse events of special interest, and treatment stopping because of treatment-emergent adverse events through Week 12.[1] The study also checks changes in laboratory tests, physical examination findings, and vital signs through Week 12.[1]

The main efficacy measure is the proportion of participants who reach clinical remission at Week 12.[1] In this study, clinical remission is defined by a modified Mayo Score of 2 or less, a Mayo endoscopic subscore of 1 or less, rectal bleeding subscore of 0, and stool frequency subscore of 1 or less.[1] These scores are used to show how active ulcerative colitis is, with lower scores meaning less disease activity.[1]

Study design and phase

This is a Phase 1 trial, which is an early stage of testing.[1] Phase 1 studies usually focus on safety and tolerability, and this trial follows that pattern by also looking for early signs of efficacy, or benefit.[1] The study compares MB-001 with a placebo, which is a look-alike treatment that has no active ingredient.[1]

MB-001 is given orally in this trial, meaning it is taken by mouth.[1] The placebo uses the same formulation excipients as the MB-001 product except for the active ingredient.[1]

What the study may mean for patients

This study is designed to learn whether MB-001 can be studied safely in people with active ulcerative colitis and whether it may help reduce disease signs.[1] The key patient-focused outcome is whether more participants can reach remission by Week 12, while also watching for unwanted medical problems during treatment.[1] Because the trial is early stage, it is mainly about learning and comparison rather than proving long-term benefit.[1]

Trial ID Phase Condition studied Status Enrollment
2025-524719-35-00 Phase 1 Ulcerative colitis Authorised 100

FAQ

  • What is being studied in MB-001 clinical trials? The trials are testing MB-001 in adults with moderate to severe ulcerative colitis. They look at both safety and whether the treatment may help reduce disease activity.
  • Who can take part in these trials? The study is for adults with moderately to severely active ulcerative colitis. The trial data do not give more detailed entry rules.
  • What phase is the MB-001 study? The trial is listed as Phase 1. This is an early stage of testing, usually focused on safety and initial signs of effectiveness.
  • What results are the researchers measuring? Researchers are measuring side effects, lab tests, physical exams, vital signs, and whether participants reach clinical remission by Week 12. Clinical remission means the disease signs are low enough to meet a set score.
  • Is a placebo used in the study? Yes. The trial includes a placebo, which looks like the study drug but has no active ingredient. This helps compare results fairly.

Ongoing Clinical Trials on MB-001

  • A study to evaluate the safety and effectiveness of MB-001 in adults with moderate to severe ulcerative colitis

    Recruiting

    1 1
    Investigated drugs:
    Poland

Glossary

  • Ulcerative colitis: A long-term disease that causes swelling and sores in the colon and rectum, which are parts of the large bowel.
  • Moderate to severe: This means the disease is not mild. Symptoms and inflammation are strong enough to need close study.
  • Phase 1: An early stage of clinical testing. It usually focuses on safety, tolerability, and early signs that a treatment may work.
  • Interventional study: A trial where researchers give a treatment and then measure what happens.
  • Placebo: A look-alike treatment with no active ingredient. It is used for comparison.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Treatment-emergent adverse event: A side effect or medical problem that starts or gets worse after the study treatment begins.
  • Serious adverse event: A harmful medical problem that is severe, may need hospital care, or may be life-threatening.
  • Clinical remission: A state where signs of the disease are very low or absent based on the study’s scoring system.
  • Modified Mayo Score: A score used to measure ulcerative colitis activity. Lower scores mean less active disease.
  • Mayo endoscopic subscore: A score from a scope test that shows how much inflammation is seen inside the bowel.
  • Rectal bleeding subscore: A part of the disease score that measures bleeding from the rectum.
  • Stool frequency subscore: A part of the disease score that measures how often bowel movements happen.

References

  1. https://clinicaltrials.gov/study/2025-524719-35-00