Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Sclerosing Cholangitis

In brief

This is a multicenter, randomized, double-blinded placebo controlled trial to assess the benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers of liver injury in PSC; 2) improves PSC patient symptoms; and 3) is safe in patients with PSC. We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.

Key facts

Study ID

NCT03561584

Run by

Brigham and Women's Hospital

People needed

32

Starts

2018-07-01

Expected to finish

2026-03-03

Last updated by the study team

2026-03-12

Who can join

Age: 15 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 15-80
• 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 > 1.67 times the upper limit of normal (ULN) at screening
• Inflammatory bowel disease
• 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 50% of all enrolled patients).
• We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.

You may not qualify if…

• Anticipated need for liver transplant within one year as determined by Mayo PSC risk score treatment
• 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
• Known intolerance to sulfasalazine (including but not limited to allergy to sulfa or mesalamine) or folic acid
• History of cholangiocarcinoma or colon cancer within 5 years
• History of colectomy with > 1/3 bowel resected
• Treatment with any investigational agents, within two months or 5 half-lives of the investigational product, whichever is longer.
• Active illicit drug or alcohol abuse
• Current or past use of sulfasalazine within 6 months of enrollment.
• Need for chronic use of antibiotics
• Evidence of bacterial cholangitis within 6 months of enrollment
• In patients with Ulcerative Colitis, simple clinical colitis activity index of > 4 or, if Crohn's disease, a Harvey-Bradshaw index of > 5
• Chronic kidney injury (eGFR < 59)
• Pregnancy or lactation

Where it is running

• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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