A study evaluating 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)
- Conditions
- Primary Biliary CholangitisMedDRA version: 20.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis System Organ Class: 100000004871Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-002996-91-DE
- Lead Sponsor
- CymaBay Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 128
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 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 or intolerant to UDCA
5.AP = 1.67 × ULN
6.Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
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 or simvastatin
13.Current use of obeticholic acid
14.Use of an experimental or unapproved treatment for PBC
15.Use of experimental or unapproved immunosuppressant
16.Adverse event leading to MBX-8025 discontinuation from CymaBay’s phase 2 PBC study CB8025-21528
17.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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method