Primary Biliary Cholangitis MedDRA version: 20.0 Level: PT Classification code 10008604 Term: Cholangitis System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Concentration unit: IU/mg international unit(s)/milligram
Concentratio
Sponsors
ELI LILLY & COMPANY, LILLY CORPORATE CENTER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 40 mIU/mL; or ii. A woman 55 years of age or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; or iii. A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of baricitinib 4-mg QD compared to placebo on PBC disease;Secondary Objective: To evaluate the effect of baricitinib 2-mg QD compared to placebo on PBC disease To evaluate the effect of baricitinib 4-mg and 2-mg QD compared to placebo on PBC symptoms;Primary end point(s): Change from baseline in ALP;Timepoint(s) of evaluation of this end point: at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with ALP <1.67 x ULN (and at least 15% decrease from baseline) and total bilirubin<ULN Change from baseline in itch as measured by Itch NRS Change from baseline in fatigue as measured by Fatigue NRS;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Italy, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed