Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05940558
Brief Summary:
This is a Phase IIa (proof of concept), single center clinical trial to evaluate the safety and efficacy of daily MBF-118 oral treatment during 28 days in Crohn's disease patients on top of standard of care.
Detailed Description:
This is a Phase 2a study to evaluate the safety, tolerability and exploratory efficacy of daily oral treatment with either 100 mg or 200 mg MBF-118 during 28 days in Crohn's disease patients diagnosed with stenosis, in order to provide reliable safety, tolerability, and PK data that will guide drug dose and therapeutic regimen choices in subsequent clinical studies.
The study design is a single-center, open-label group consisting of two cohorts, one dosed with 100 mg MBF-118 daily for 28 days and one dosed with 200 mg MBF-118 daily for 28 days, in approximately 5 subjects per cohort without placebo control. No randomisation is required. The first five patients to start initiate the trial will be dosed with 100 mg. The subsequent five patients initiating the trial will be dosed with 200 mg.
For each subject, the study duration will last a total of approximately 14-16 weeks consisting of a screening period of 2-4 weeks, a treatment period of 4 weeks and a follow-up period of 8 weeks.
The subjects who have previously completed 28 days treatment with 100 mg MBF-118 and did not show any serious adverse effects will have the option to participate to an open-label 90-day extension phase. The extension phase will last approximately 19-21 weeks consisting of up to 21 days screening, 90 treatment days and 42 follow-up days.
Study:
NCT05940558
Study Brief:
Protocol Section:
NCT05940558