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.
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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