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Mbf-118

Clinical trials are investigating Mbf-118 in people with Crohn’s disease and stenosis, which means narrowing of the bowel. These studies aim to assess safety, tolerability, and early signs of benefit, along with other research measures such as pharmacokinetics and pharmacodynamics.

Table of Contents

Trial overview

The available trial data describe one study of Mbf-118 in people with Crohn’s disease and stenosis, which means narrowing of the bowel.[1] The study was designed to assess initial antifibrotic efficacy, safety, tolerability, pharmacokinetic, and pharmacodynamic information.[1]

This was an interventional trial, meaning participants received the study treatment so researchers could observe its effects.[1] The brief summary says Mbf-118 was studied on top of standard of care for 28 days, with follow-up to Day 56.[1]

Who was studied

The trial focused on participants with Crohn’s disease.[1] More specifically, it included patients with stenosis, which is a narrowing that can happen in the bowel and may make symptoms harder to manage.[1]

The study enrolled 10 participants, so this was a small early-stage trial.[1] The study took place at a single centre, meaning one research site was used.[1]

Study design and phase

This was a Phase 2 study.[1] Phase 2 trials usually look for early signs that a treatment may help, while still paying close attention to safety.[1]

The study was open label, which means everyone in the study knew the treatment being given.[1] It was also single-centre, so the research was carried out in one place rather than at multiple sites.[1]

The intervention listed in the trial record was Mbf-118 at 80 mg taken orally.[1] The trial record does not provide more detailed dosing schedules beyond this description.[1]

What was measured

The main endpoint, or main result the study wanted to measure, was safety and tolerability over 28 days from baseline to the end of follow-up at Day 56.[1] Tolerability means how well participants can take the treatment without major problems.[1]

Researchers looked at the number and severity of adverse events, which are unwanted medical problems that happen during a study.[1] They also checked for clinically significant changes in vital signs, physical examination findings, laboratory measurements, and ECGs.[1]

The study also aimed to assess the initial antifibrotic efficacy of Mbf-118.[1] Antifibrotic means related to reducing fibrosis, or scarring and thickening of tissue.[1] In addition, the trial planned to collect pharmacokinetic and pharmacodynamic data.[1]

Study status and enrollment

The trial status is Completed.[1] That means the planned study activities have finished and the data collection period is over.[1]

Only 10 participants were enrolled, which suggests this was a small early study meant to gather initial information rather than final proof of benefit.[1]

What these trial terms mean for patients

Stenosis is important because narrowing of the bowel can affect how food and fluid move through the digestive system.[1] Trials in this group often focus on whether a treatment is safe and whether it may help with the narrowing process.[1]

Vital signs are basic body measurements such as pulse and blood pressure, and they help researchers see if a treatment is causing changes in the body.[1] Laboratory measurements are blood or other test results, while an ECG is a heart test that records electrical activity.[1]

Pharmacokinetic data show how the body handles a treatment, and pharmacodynamic data show what the treatment does in the body.[1] In this study, those data were collected as part of the early research picture for Mbf-118.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05940558 Phase 2 Crohn’s disease with stenosis Completed 10

FAQ

  • What is being studied in the Mbf-118 trial? The trial is studying Mbf-118 in people with Crohn’s disease who have stenosis. Researchers are mainly looking at safety and tolerability, and also early antifibrotic effects.
  • Who can take part in the trial? The trial is for participants with Crohn’s disease and stenosis. It is a single-centre study, so people are enrolled at one study site.
  • What phase is the Mbf-118 trial? This is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment may help a condition, while still checking safety.
  • What did the researchers measure? The main measure was safety and tolerability over 28 days, with follow-up to Day 56. They also tracked adverse events, vital signs, physical exams, laboratory tests, and ECGs.
  • Was the trial completed? Yes, the trial status is completed. It enrolled 10 participants.

Ongoing Clinical Trials on Mbf-118

  • Study on the Safety and Effects of MBF-118 for Crohn’s Disease Patients with Stenosis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Crohn’s disease: A long-term inflammatory bowel disease that can affect any part of the digestive tract and may cause pain, diarrhea, and other symptoms.
  • Stenosis: A narrowing of a body passage. In Crohn’s disease, this often means narrowing of the bowel.
  • Phase 2: A trial stage that looks at early signs of benefit and continues to check safety in a small group of people.
  • Open label: A study design where both the researchers and the participants know which treatment is being given.
  • Single-centre: A study carried out at just one hospital or research site.
  • Interventional study: A trial where participants receive a study treatment so researchers can measure its effects.
  • Antifibrotic: Related to reducing fibrosis, which is scarring or thickening of tissue.
  • Pharmacokinetic: How the body absorbs, moves, and removes a treatment.
  • Pharmacodynamic: How a treatment affects the body and what changes it causes.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • ECG: Electrocardiogram, a test that records the heart’s electrical activity.

References