Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis

Exclusion Criteria

• •1. Small duct PSC (clinical biochemical and histological features compatible with PSC, but having a normal cholangiogram).
• •2. Presence of a dominant stricture unless brushings and/or biopsies of the stricture are negative for dysplasia or malignancy within 6 months of screening.
• •3. Surgical or endoscopic biliary tree interventions for treatment of clinically significant strictures within 6 months of screening.
• •4. IBD flare (Mayo UC disease activity score \> 5 including endoscopic evaluation) within 3 months prior to screening.
• •5. Secondary cause of sclerosing cholangitis (e.g., choledocholithiasis, post-surgical biliary stricture, intra-arterial chemotherapy, recurrent pancreatitis, IgG4 associated cholangiopathy, AIDS cholangiopathy).
• •6. AST or ALT ≥ 5 x ULN at screening.
• •7. History or presence of any other concomitant significant liver disease as assessed by the Investigator.
• •8. Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease).
• •9. Known history of human immunodeficiency virus (HIV) infection.
• •10. The anticipated need for a surgical procedure within 20 weeks from randomization.
• •11. Any female who is pregnant or lactating or who is planning to become pregnant within 20 weeks of randomization.
• •12. History of cancer, except for basal or squamous cell carcinoma of the skin, or with any laboratory or physical exam or diagnostic procedure finding suggestive of current malignancy.
• •13. Family history of any documented hereditary cancer syndrome.
• •14. History of alcohol or other substance abuse within 1 year prior to screening.
• •15. Receipt of an investigational drug, biologic, or medical device within 30 days prior to Screening, or 5 half-lives of the study agent, whichever is longer.
• •16. History of noncompliance with medical regimens, unreliability, mental instability or incompetence that could compromise the validity of informed consent or lead to noncompliance with the study protocol.
• •17. Any other conditions or abnormalities which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the subject, or interfere with the subject participating in or completing the study.