The goal of this clinical trial is to learn if MB-001, an oral biologic, is able to treat patients with ulcerative colitis. Participants will be asked to take MB-001 or a matching placebo once-daily for a period of 12 weeks. Researchers will compare MB-001 to placebo to investigate its effects on clinical symptoms as well as endoscopic and histopathological findings. Patients will be offered open-label extension for another 12 weeks following the double-blind, placebo-controlled part of the study. Participants will keep a daily diary to record their symptoms and will have up to nine clinic visits.
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of adverse events
Timeframe: From study start until 4 weeks after end of treatment
Changes in laboratory parameters: Platelet count
Timeframe: Week 12
Changes in laboratory parameter: Hemoglobin
Timeframe: Week 12
Changes in laboratory parameter: Hematocrit
Timeframe: Week 12
Changes in laboratory parameter: Red Blood Cell (RBC) count
Timeframe: Week 12
Changes in laboratory parameter: Prothrombin time
Timeframe: Week 12
Number of participants with abnormal laboratory tests results
Timeframe: Week 12
Number of participants with abnormal urinalysis results
Timeframe: Week 12
Proportion of participants achieving clinical remission
Timeframe: Week 12