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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
Administered orally.
Administered orally.
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
Change From Baseline in Alkaline Phosphatase (ALP)
Change from baseline in Alkaline Phosphatase (ALP)
Time frame: Baseline, Week 12
Percentage of Participants With Alkaline Phosphatase (ALP) <1.67 x Upper Limit of Normal (ULN) (and at Least 15% Decrease From Baseline) and Total Bilirubin Level Less Than ULN
Percentage of participants with alkaline phosphatase (ALP) \<1.67 x Upper Limit of Normal (ULN) (and at least 15% decrease from baseline) and total bilirubin level less than ULN.
Time frame: Week 12
Change From Baseline in Itch Numeric Rating Scale (NRS)
Change from baseline in itch NRS. The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by circling the number that best describes the worst level of itching in the past 7 days.
Time frame: Baseline, Week 12
Change From Baseline in Fatigue NRS
Change from baseline in fatigue NRS. The Fatigue NRS is a single-item, patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Overall severity of a participant's fatigue is indicated by selecting the number that describes the worst level of fatigue during the past 7 days.
Time frame: Baseline, Week 12
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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
...and 2 more locations