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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05835505
Other study ID # 2023P000535
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 12, 2023
Est. completion date December 1, 2025

Study information

Verified date December 2023
Source Brigham and Women's Hospital
Contact Joshua Korzenik, MD
Phone 617 732-6389
Email jkorzenik@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with primary sclerosing cholangitis. Participation in this study will take 8 weeks long and the study is structured as a cross-over study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order 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 9 study visits, all of which will be remote. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool sample for a few lab tests throughout the study. For the lab tests, a research nurse will visit the participant in-home for the convenience of the participant.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date December 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP) demonstrating intrahepatic and/or extrahepatic biliary strictures, beading or irregularity consistent with PSC. - 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: - Anticipated need for liver transplant within one year as determined by Mayo PSC risk score - 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

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
United States Brigham and Women's Hospital Chestnut Hill Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alkaline Phosphatase (ALP) Test Result The primary endpoint for this study is the capacity of BRS201 to normalize alkaline phosphatase levels from baseline (week 0) compared to end of active treatment (4 weeks). 4 weeks
See also
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Completed NCT03041662 - Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
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Completed NCT02247934 - Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC) N/A
Completed NCT01088607 - Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis Phase 1
Terminated NCT01142323 - Pilot Study of Fenofibrate for PSC Phase 1/Phase 2
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Completed NCT02943460 - Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis Phase 2
Completed NCT00951327 - Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP) N/A
Completed NCT04024813 - A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC Phase 2
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