This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 8 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug for four weeks.
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
NOT_YET_RECRUITINGBrigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
RECRUITINGSulfur Metabolism
The primary measure of dose response will be urinary measures of sulfur metabolism including a \> 50% reduction from pretreatment levels sulfate, and thiosulfate.
Time frame: 4 weeks
Simple Clinical Colitis Activity Index (SCCAI)
Clinical symptoms assessed by SCCAI which measures patient reported outcomes on a scale of 0 to 19, where a higher score indicates more severe activity and active disease is a score of 5 or more.
Time frame: 12 weeks
Plasma nitrite, nitrate, or nitrosothiol
Correlation between changes in plasma nitrite, nitrate or nitrosothiol level in relation to calprotectin
Time frame: 8 weeks
Normalization of fecal calprotectin lab measurements
The capacity of study drug to normalize fecal calprotectin levels from baseline (week 0) compared to end of active treatment (4 weeks) and at week 6.
Time frame: 8 weeks
Reduction in fecal calprotectin lab measurements
Reduction in fecal calprotectin to \< ULN at the end of active treatment
Time frame: 4 weeks
Mayo Score
The primary endpoint for this study is change in Total Mayo Score with improvement being a reduction in 3 points and remission being a score of 0 or 1 from day 0 to end of week 4 (at second flexible sigmoidoscopy).
Time frame: 4 weeks
Tissue Analysis
Analysis of tissue metabolomics and proteomics at day 0 vs day 28;
Time frame: 4 weeks
Mitochondria evaluation
Changes in mitochondria on EM evaluation
Time frame: 12 weeks
Urine Assays
Urine levels for thiosulfate, thiocyanate, nitrate and nitrite;
Time frame: 12 weeks
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