In short
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.
Key points
- MB-001 is being studied in a Phase 1 trial for adults with moderate to severe ulcerative colitis. The study is authorised and plans to enroll 100 participants. Researchers are looking at safety, tolerability, lab results, physical exams, vital signs, and early signs of benefit. The main efficacy goal is to see how many participants reach clinical remission by Week 12. A placebo is included so results can be compared fairly.
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. It is an interventional study, which means researchers give a treatment and then measure the results. The study is authorised and plans to enroll 100 participants.
Who can participate
The trial is for adults with moderately to severely active ulcerative colitis. The source data do not list more detailed entry rules, so the available information only confirms the condition, age group, and disease activity level.
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. The study also checks changes in laboratory tests, physical examination findings, and vital signs through Week 12.
The main efficacy measure is the proportion of participants who reach clinical remission at Week 12. 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. These scores are used to show how active ulcerative colitis is, with lower scores meaning less disease activity.
Study design and phase
This is a Phase 1 trial, which is an early stage of testing. 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. The study compares MB-001 with a placebo, which is a look-alike treatment that has no active ingredient.
MB-001 is given orally in this trial, meaning it is taken by mouth. The placebo uses the same formulation excipients as the MB-001 product except for the active ingredient.
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. The key patient-focused outcome is whether more participants can reach remission by Week 12, while also watching for unwanted medical problems during treatment. Because the trial is early stage, it is mainly about learning and comparison rather than proving long-term benefit.