Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

Status Completed

Clinical Trial Summary

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

Clinical Trial Description

Primary: To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 8 weeks of treatment Secondary: To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 12 and 26 weeks of treatment To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 52 weeks of treatment To evaluate the pharmacokinetics (PK) of MBX-8025 Exploratory: To evaluate the effect of MBX-8025 on bile acids, additional markers of inflammation and renal function MBX-8025 doses of 1 mg and 15 mg may be evaluated if dose adjustment occurs ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02955602
Study type	Interventional
Source	CymaBay Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	November 28, 2016
Completion date	July 8, 2019

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04526665` - Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)	Phase 3
Recruiting	`NCT02931513` - sCD163 in PBC Patients - Assessment of Treatment Response
Active, not recruiting	`NCT02924701` - sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
Completed	`NCT02659696` - Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
Completed	`NCT02078882` - Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis	Phase 4
Completed	`NCT01389973` - A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid	Phase 2
Completed	`NCT01603199` - High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis	N/A
Completed	`NCT01857284` - Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis	Phase 3
Completed	`NCT05374200` - Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)	N/A
Recruiting	`NCT02937012` - Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders	Phase 3
Completed	`NCT02376335` - B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis	Phase 2
Recruiting	`NCT01662973` - Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis	Phase 1/Phase 2
Active, not recruiting	`NCT04751188` - A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis	Phase 3
Recruiting	`NCT04514965` - Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Recruiting	`NCT03668145` - Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis	N/A
Completed	`NCT02557360` - Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis	Phase 4
Recruiting	`NCT01440309` - Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis	Phase 1
Completed	`NCT01249092` - Pentoxifylline for Primary Biliary Cirrhosis	Phase 2
Completed	`NCT01510860` - Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis	Phase 4
Completed	`NCT04604652` - Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis	Phase 2