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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

Subjects will be eligible for randomization only if they meet all of the
following criteria within the screening period, which is =49 days prior to randomization, unless
specifically defined:
Type of Patient and Disease Characteristics
[1] Male or female patients who are at least 18 years of age.
[2] 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; [Lindor 2009; EASL 2017]), as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
? History of elevated ALP levels for at least 6 months
? Positive antimitochondrial antibodies titer
? Liver biopsy consistent with PBC
[3] Have ALP =1.67 x ULN but <6 x ULN
[4] Taking UDCA for at least 52 weeks (stable dose for at least 12 weeks) prior to Visit 3
(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 Visit 3 (Week 0).
Patient Characteristics
[5] Nonpregnant, nonbreastfeeding female patients of childbearing
potential:
a. Patients who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their
preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with the opposite sex during the entirety of the study and for at least 1 week following the last dose of investigational product.
Total abstinence is defined as refraining from intercourse during the entirety of the study and for at least 1 week following the last dose of
investigational product. Periodic abstinence such as calendar, ovulation, symptothermal, postovulation methods, and withdrawal are not acceptable methods of contraception b. Otherwise, patients must agree to use for the entirety of the study and for at least 1 week following the last dose of investigational product, 2
effective methods of contraception, where at least 1 form is highly effective (such as combination oral contraceptives, implanted contraceptives or
intrauterine devices). Effective contraception (such as male or female condoms with
spermicide, diaphragms with spermicide or cervical sponges) may be used as the second therapy. Barrier protection methods without concomitant
use of a spermicide are not a reliable or acceptable method.
Female patients of nonchildbearing potential may participate without requirements for contraception. This includes female patients who are:
a. Infertile due to surgical sterilization (hysterectomy, bilateral
oophorectomy,
or tubal ligation), congenital anomaly such as mullerian agenesis; or
b. Postmenopausal – defined as either
i. A woman at least 50 years of age with an intact uterus, not on
hormone therapy, who has had either
1. Cessation of menses for at least 1 year,

Exclusion Criteria

Medical Conditions
[7] History or presence of other concomitant liver diseases including:
a. Hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA] positive). ? Note: Patients who have documented anti-HCV treatment for a past HCV infection AND are HCV RNA-negative with a sustained viral response may be enrolled in the study.
b. Hepatitis B virus (HBV) infection defined as:
? positive for hepatitis B surface antigen (HBsAg), or
? positive for hepatitis B core antibody (HBcAb)
c. Primary sclerosing cholangitis
d. Alcoholic liver disease
e. Autoimmune liver disease other than PBC, such as overlap hepatitis
f. Nonalcoholic steatohepatitis
g. Gilbert's syndrome
[8] Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:
a. Liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score = 15
b. 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
c. Cirrhosis, including history or presence of one or more of the
following: spontaneous bacterial peritonitis, hepatocellular carcinoma
d. Hepatorenal syndrome (type I or II)
[9] Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine of <90 mL/min/1.73 m2.
[10] 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 patient's participation in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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