Study of Novel Therapeutics for Acute Remedy of Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Severe outpatient or hospitalized for an acute UC flare
Ability to give consent
Patients with a confirmed diagnosis of UC for > 3 months
History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy
Disqualifiers
History of uncontrolled hypertension with systolic BP > 140 and systolic BP > 90
Chronic kidney disease as defined by GFR <55mL/min
Impaired hepatic function (transaminases elevated > 2.5 x ULN) unless due to PSC
Evidence of C. difficile (Negative test result within 1 month is acceptable)
Trial design
Design model
Single group
Treatments tested in this trial
BRS201
DrugGroups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug for four weeks.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: BRS201 ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sulfur 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 weeksSecondary outcomes
1
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 weeks2
Plasma nitrite, nitrate, or nitrosothiol
Correlation between changes in plasma nitrite, nitrate or nitrosothiol level in relation to calprotectin
Time frame
8 weeks3
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 weeks4
Reduction in fecal calprotectin lab measurements
Reduction in fecal calprotectin to \< ULN at the end of active treatment
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov