A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
NCT03742973 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2020-10-14
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).
Conditions
Interventions
- DRUG
-
Administered orally.
- DRUG
-
Administered orally.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
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
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-28
- Primary Completion
- 2019-09-26
- Completion
- 2019-09-26
- FDA Drug
- Yes
Countries
- United States
- Puerto Rico
Study Locations
More Related Trials
-
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
NCT05293938 ·Status: WITHDRAWN
-
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
NCT01389973 ·Status: COMPLETED ·Phase: PHASE2
-
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
NCT02937012 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
NCT06699121 ·Status: RECRUITING ·Phase: PHASE2
-
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
NCT05014672 ·Status: COMPLETED ·Phase: PHASE2
-
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
NCT02932449 ·Status: COMPLETED
-
Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
NCT01654731 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
NCT04006145 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
NCT03226067 ·Status: COMPLETED ·Phase: PHASE2
-
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
NCT03602560 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
NCT05104853 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
NCT01899703 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
NCT01904058 ·Status: COMPLETED ·Phase: PHASE2
-
Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC)
NCT06798454 ·Status: COMPLETED ·Phase: PHASE1
-
Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)
NCT05448170 ·Status: AVAILABLE
-
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
NCT06383403 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis
NCT02376335 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
NCT03124108 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
NCT04526665 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
NCT06488911 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
NCT06007651 ·Status: TERMINATED ·Phase: PHASE1
-
A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
NCT06591455 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
NCT02965911 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
NCT02321306 ·Status: WITHDRAWN ·Phase: PHASE2
-
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
NCT02966834 ·Status: COMPLETED ·Phase: PHASE2