A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Primary Biliary Cholangitis

In brief

This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).

Key facts

Study ID

NCT03742973

Run by

Eli Lilly and Company

People needed

2

Starts

2019-03-28

Expected to finish

2019-09-26

Last updated by the study team

2020-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of PBC (consistent with American Association for the Study of Liver Disease (AASLD) and European Association for Study of the Liver (EASL) Practice Guidelines; as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
• History of elevated Alkaline Phosphatase (ALP) levels for at least 6 months
• Positive antimitochondrial antibodies titer
• Liver biopsy consistent with PBC
• Have ALP ≥1.67 x ULN but ≤6 x Upper Limit Normal (ULN).
• Taking UDCA for at least 52 weeks (stable dose for at least 12 weeks) prior to Week 0, or have previously taken, but are intolerant (in the opinion of the investigator) to UDCA and have not received UDCA for at least 12 weeks prior to Week 0.
• Nonpregnant, nonbreastfeeding female participants of childbearing potential.

You may not qualify if…

• History or presence of other concomitant liver diseases including:
• Hepatitis C virus (HCV) infection
• Hepatitis B virus (HBV) infection
• Primary sclerosing cholangitis
• Alcoholic liver disease
• Autoimmune liver disease other than PBC, such as overlap hepatitis
• Nonalcoholic steatohepatitis
• Gilbert's syndrome
• Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:
• Liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥15
• Portal hypertension with complications, including known gastric or esophageal varices, ascites, history of variceal bleeds or related therapeutic or prophylactic interventions (e.g., beta blockers, insertion of variceal bands or transjugular intrahepatic portosystemic shunt), or hepatic encephalopathy
• Cirrhosis, including history or presence of one or more of the following:
• spontaneous bacterial peritonitis
• hepatocellular carcinoma
• Hepatorenal syndrome (type I or II)
• Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine of <90 milliliters/minute/1.73 m2.
• Have screening electrocardiogram (ECG) abnormalities that in the opinion of the investigator or the sponsor are clinically significant and indicate an unacceptable risk for the participant's participation in the study.
• Have experienced any of the following within 12 weeks of screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
• Have a history of venous thromboembolism (VTE) (deep vein thrombosis/pulmonary embolism [DVT/PE]).
• Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
• Have a current or recent (<4 weeks prior to randomization) clinically serious infection or any other active or recent infection that, in the opinion of the investigator, would pose an unacceptable risk to the participant if participating in the study.
• Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
• Have active tuberculosis (TB) disease determined on the basis of a positive medical history, physical examination, or chest radiography (per local standard of care) or latent TB infection (LTBI).
• Have any of the following specific abnormalities based on screening central lab test results:
• Hemoglobin <10 grams per deciliter (100.0 grams per liter)

Where it is running

• Southern California GI and Liver Centers (SCLC) — Coronado, California, United States
• University of California, Davis - Health Systems — Sacramento, California, United States
• University of Colorado School of Medicine — Aurora, Colorado, United States
• Schiff Center for Liver Diseases/University of Miami — Miami, Florida, United States
• The Institute for Digestive Health and Liver Disease at Mercy — Baltimore, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• NYU Langone — New York, New York, United States
• UH Cleveland Medical Center — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Klinical Investigations Group, LLC — San Juan, PR, Puerto Rico
• University of Puerto Rico, Medical Sciences Campus — San Juan, PR, Puerto Rico

Full record on ClinicalTrials.gov

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