A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.
• Has definite or probable AIH diagnosis.
• Has had a liver biopsy or Fibroscan™ within 3 years and the severity of hepatic dysfunction is limited to the following:
• Metavir Stage 0 to stage 3 fibrosis (according to liver biopsy) or Fibroscan™ results
• ALT and AST values not exceeding 10x ULN
• Normal bilirubin and prothrombin time (PT/INR)
• Has elevated liver test results (ALT) at least 1.25 x ULN and not exceeding 10 x ULN at baseline.
• Has had a failed response, incomplete response, intolerant, ineligible or unwilling to take current immunosuppressive therapies. Current immunosuppressive therapy is defined as prednisone or other steroids with or without azathioprine.