Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis

• Status: Not yet recruiting
• Trial end date: 2023-06-17
• Target enrollment: 0
• Participant gender: All

Summary

This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albireo

Criteria

Key inclusion criteria:

• Clinical and radiological diagnosis of large-duct PSC via magnetic resonance cholangiopancreatography movement-related cortical potential (MRCP) or equivalent imaging modality that excludes biliary obstruction and malignancy within 6 months before screening

• Alkaline phosphatase (ALP) > 1.5 × upper limit of normal (ULN) but ≤ 10 × ULN

• Total bilirubin < 3 × ULN

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × ULN

• Baseline serum bile acid level at Screening must be > ULN

• Clinically stable for at least 3 months prior to screening

Key exclusion criteria:

• Presence of documented secondary sclerosing cholangitis, small duct PSC, known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis or other causes of chronic liver disease

• Biliary intervention within 3 months prior to study enrollment or planned

• Inflammatory bowel disease (IBD) with uncontrolled moderate to severe activity and/or on treatment with any immunosuppressive, immunomodulator, or biologic agent for treatment of IBD. Treatment with corticosteroids in the previous 4 weeks

• History of human immunodeficiency virus infection or any other known relevant infection (e.g., tuberculosis)

• History of colostomy or colectomy

• History of malignancy, including hepatocellular carcinoma within the past 10 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated

• History of transplants, including liver transplantation, or currently on active transplantation list

• Known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis

• Liver cirrhosis as assessed by any of the following:

1. historical liver histology suspected liver fibrosis

2. liver stiffness measurement, assessed by FibroScan (FibroScan value > 14.4 kPa)

3. current or history of signs and symptoms of hepatic decompensation (including, but not limited to, jaundice, ascites, variceal haemorrhage, and/or hepatic encephalopathy)

• Treatment with rifampicin, CYP3A4 substrates, vitamin D or fibrates (unless patient is on a stable dose ≥ 6 months prior to baseline) and with medications that slow gastrointestinal motility

• Exposure to an investigational drug, biologic agent, or medical device within 30 days prior to Screening, or 5 half-lives of the study agent, whichever is longer

• Platelet count < 150 000/mm3

• Albumin level < 3.0 g/dL

• International normalised ratio (INR) > 1.4 (the patient may be treated with vitamin K intravenously, and if INR is ≤ 1.4 at resampling, the patient may be enrolled)

• Advanced renal disease glomerular filtration rate (GFR) <70 mL/min/1.73 m2)