Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)

• Status: Terminated
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study, to evaluate the effects of two doses of seladelpar/MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CymaBay Therapeutics, Inc.
• Treatments: Seladelpar; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

1. Must have given written informed consent (signed and dated) and any authorizations required by local law

2. 18 to 75 years old (inclusive)

3. Male or female with a diagnosis of PBC, by at least two of the following criteria:

• History of AP above ULN for at least six months

• Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies

• Documented liver biopsy result consistent with PBC

4. On a stable and recommended dose of UDCA for the past twelve months

5. AP ≥ 1.67 × ULN

6. For females of reproductive potential, use of at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose. For male subjects, use of appropriate contraception (e.g., condoms), so their female partners of reproductive potential do not become pregnant during the study and for at least two weeks after the last dose

Exclusion Criteria:

1. A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment)

2. AST or ALT > 3 × ULN

3. Total bilirubin > 2 × ULN

4. Auto-immune hepatitis

5. Primary sclerosing cholangitis

6. Known history of alpha-1-Antitrypsin deficiency

7. Known history of chronic viral hepatitis

8. Creatine kinase above ULN

9. Serum creatinine above ULN

10. For females, pregnancy or breast-feeding

11. Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening

12. Current use of fibrates, including fenofibrates, or simvastatin

13. Use of an experimental treatment for PBC

14. Use of experimental or unapproved immunosuppressant

15. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator