Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-29 @ 3:18 AM
Study NCT ID:
NCT02955602
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
Sponsor:
Gilead Sciences
Organization:
Study Overview
Official Title:
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)
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
Detailed 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: