In short
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.
Key points
- Mbf-118 has been studied in a Phase 2 trial in people with Crohn’s disease and stenosis, which is narrowing of the bowel. The study was open label and single-centre, and it enrolled 10 participants. Researchers mainly looked at safety and tolerability over 28 days, with follow-up until Day 56. They also measured adverse events, vital signs, physical exam findings, laboratory tests, and ECGs. The trial also explored early antifibrotic effects, plus pharmacokinetic and pharmacodynamic profiles. The trial status is completed.
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. The study was designed to assess initial antifibrotic efficacy, safety, tolerability, pharmacokinetic, and pharmacodynamic information.
This was an interventional trial, meaning participants received the study treatment so researchers could observe its effects. The brief summary says Mbf-118 was studied on top of standard of care for 28 days, with follow-up to Day 56.
Who was studied
The trial focused on participants with Crohn’s disease. More specifically, it included patients with stenosis, which is a narrowing that can happen in the bowel and may make symptoms harder to manage.
The study enrolled 10 participants, so this was a small early-stage trial. The study took place at a single centre, meaning one research site was used.
Study design and phase
This was a Phase 2 study. Phase 2 trials usually look for early signs that a treatment may help, while still paying close attention to safety.
The study was open label, which means everyone in the study knew the treatment being given. It was also single-centre, so the research was carried out in one place rather than at multiple sites.
The intervention listed in the trial record was Mbf-118 at 80 mg taken orally. The trial record does not provide more detailed dosing schedules beyond this description.
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. Tolerability means how well participants can take the treatment without major problems.
Researchers looked at the number and severity of adverse events, which are unwanted medical problems that happen during a study. They also checked for clinically significant changes in vital signs, physical examination findings, laboratory measurements, and ECGs.
The study also aimed to assess the initial antifibrotic efficacy of Mbf-118. Antifibrotic means related to reducing fibrosis, or scarring and thickening of tissue. In addition, the trial planned to collect pharmacokinetic and pharmacodynamic data.
Study status and enrollment
The trial status is Completed. That means the planned study activities have finished and the data collection period is over.
Only 10 participants were enrolled, which suggests this was a small early study meant to gather initial information rather than final proof of benefit.
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. Trials in this group often focus on whether a treatment is safe and whether it may help with the narrowing process.
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. Laboratory measurements are blood or other test results, while an ECG is a heart test that records electrical activity.
Pharmacokinetic data show how the body handles a treatment, and pharmacodynamic data show what the treatment does in the body. In this study, those data were collected as part of the early research picture for Mbf-118.