Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2023-12-12
2026-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BRS201 Arm
In Group 1 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) for 4 weeks.
In Group 2 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) for 4 weeks.
In Group 3 of the study, subjects will take receive a one-time 5g IV dose of the study drug using the FDA-approved IV product followed by the oral study drug at 2g twice daily, PO (4g daily) for 4 weeks.
In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
BRS201
Groups 1, 2, 3, and 4 will all contain 7 subjects each, with each subject receiving active study drug and placebo in a randomized order; half will receive the placebo first for four weeks followed by active treatment for four weeks, while the other half will receive active treatment for four weeks followed by placebo for four weeks.
Placebo Arm
In Group 1 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) for 4 weeks.
In Group 2 of the study, subjects will take oral placebo at 2g twice daily, PO (4g daily) for 4 weeks.
In Group 3 of the study, subjects will take receive a one-time 5g IV dose of the study drug using the FDA-approved IV product followed by the oral placebo at 2g twice daily, PO (4g daily) for 4 weeks.
In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
Placebo
Groups 1, 2, 3, and 4 will all contain 7 subjects each, with each subject receiving active study drug and placebo in a randomized order; half will receive the placebo first for four weeks followed by active treatment for four weeks, while the other half will receive active treatment for four weeks followed by placebo for four weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BRS201
Groups 1, 2, 3, and 4 will all contain 7 subjects each, with each subject receiving active study drug and placebo in a randomized order; half will receive the placebo first for four weeks followed by active treatment for four weeks, while the other half will receive active treatment for four weeks followed by placebo for four weeks.
Placebo
Groups 1, 2, 3, and 4 will all contain 7 subjects each, with each subject receiving active study drug and placebo in a randomized order; half will receive the placebo first for four weeks followed by active treatment for four weeks, while the other half will receive active treatment for four weeks followed by placebo for four weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ALP \> 1.5 times the upper limit of normal (ULN) at screening.
* Subject must either be on a stable dose of ursodeoxycholic acid for \> 6 months prior to screening or have been discontinued \> 4 weeks prior to screening (enrollment of patients who are on UDCA will be limited to 60% of all enrolled patients).
Exclusion Criteria
* Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.
* Evidence of advanced liver disease including MELD score \> 10, bilirubin \> 3.0, platelet count \< 100,000; or INR \> 1.4
* Concomitant chronic liver disease including alcohol related liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary cholangitis
* Secondary causes of sclerosing cholangitis
* Patients who have a confirmed malignancy or cancer within 5 years except non-melanoma skin cancers
* Treatment with any investigational agents, within two months or 5 half-lives of the investigational product, whichever is longer.
* Active illicit drug or more than moderate alcohol consumption.
* Evidence of bacterial cholangitis within 6 months of enrollment
* In patients with Ulcerative Colitis, or, if Crohn's disease, a need for additional therapy at time of screening.
* Chronic kidney injury (eGFR \< 60)
* Pregnancy or lactation
* Uncontrolled hypertension with a systolic BP \> 140 and a systolic BP \> 90
* Prohibited medications: current use of vitamin C and prednisone
* Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
* Patients with a history of kidney stones
* Congenital or acquired immunodeficiencies
* Other comorbidities including: diabetes mellitus, systemic lupus
* An episode of acute cholangitis within 4 weeks of screening Check eligibility here: https://redcap.link/Checkmyeligibility
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joshua Korzenik
Director, Crohn's and Colitis Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joshua A Korzenik, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Womens Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sophie A Mitchell, BS
Role: primary
Siani Ellis, BS
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025P000196
Identifier Type: -
Identifier Source: org_study_id