Study Stopped
Study was terminated due to enrollment futility.
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Primary Biliary Cholangitis Who Have an Inadequate Response or Are Intolerant to UDCA
2 other identifiers
interventional
2
2 countries
12
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2019
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 15, 2018
CompletedStudy Start
First participant enrolled
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2019
CompletedResults Posted
Study results publicly available
October 14, 2020
CompletedOctober 14, 2020
October 1, 2019
6 months
November 14, 2018
September 18, 2020
September 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Alkaline Phosphatase (ALP)
Change from baseline in Alkaline Phosphatase (ALP)
Baseline, Week 12
Secondary Outcomes (3)
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
Week 12
Change From Baseline in Itch Numeric Rating Scale (NRS)
Baseline, Week 12
Change From Baseline in Fatigue NRS
Baseline, Week 12
Study Arms (4)
Baricitinib Cohort A
EXPERIMENTALParticipants received 2 milligram (mg) of Baricitinib tablet orally once a day for 12 weeks. Cohort A is not reported due to protection of personal identifiable information based on enrollment futility.
Placebo Cohort A
PLACEBO COMPARATORParticipants received placebo orally once a day for 12 weeks. Cohort A is not reported due to protection of personal identifiable information based on enrollment futility.
Baricitinib Cohort B
EXPERIMENTALParticipants received 4 mg of Baricitinib orally once a day for 12 weeks. Cohort B was planned, but due to enrollment futility, the strategic decision was made to terminate the study.
Placebo Cohort B
PLACEBO COMPARATORPlacebo administered orally. Cohort B was planned, but due enrollment futility, the strategic decision was made to terminate the study.
Interventions
Eligibility Criteria
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)
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Southern California GI and Liver Centers (SCLC)
Coronado, California, 92118, United States
University of California, Davis - Health Systems
Sacramento, California, 95817, United States
University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136, United States
The Institute for Digestive Health and Liver Disease at Mercy
Baltimore, Maryland, 21202, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
NYU Langone
New York, New York, 10016, United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Klinical Investigations Group, LLC
San Juan, PR, 00909, Puerto Rico
University of Puerto Rico, Medical Sciences Campus
San Juan, PR, 00936, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to early study termination based on enrollment futility.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2018
First Posted
November 15, 2018
Study Start
March 28, 2019
Primary Completion
September 26, 2019
Study Completion
September 26, 2019
Last Updated
October 14, 2020
Results First Posted
October 14, 2020
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.