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 

NCT02609048_inc_T8
Value
18 to 75 years old (inclusive)
NCT02609048_inc_T9
Person
years old
NCT02609048_inc_T10
Person
Male
NCT02609048_inc_T11
Person
female
NCT02609048_inc_T12
Condition
PBC
NCT02609048_inc_T13
Multiplier
at least two
NCT02609048_inc_T15
Measurement
following criteria
NCT02609048_inc_T16
Measurement
Positive Anti-Mitochondrial Antibodies (AMA) titers
NCT02609048_inc_T17
Value
>1/40
NCT02609048_inc_T18
Measurement
immunofluorescence
NCT02609048_inc_T19
Value
M2 positive
NCT02609048_inc_T20
Measurement
enzyme linked immunosorbent assay (ELISA)
NCT02609048_inc_T21
Measurement
PBC-specific antinuclear antibodies
NCT02609048_inc_T22
Value
positive
NCT02609048_inc_T23
Scope
>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
NCT02609048_inc_T24
Measurement
AP
NCT02609048_inc_T25
Value
above ULN
NCT02609048_inc_T26
Temporal
for at least six months
NCT02609048_inc_T27
Procedure
liver biopsy
NCT02609048_inc_T28
Condition
PBC
NCT02609048_inc_T29
Qualifier
stable dose
NCT02609048_inc_T30
Qualifier
recommended dose
NCT02609048_inc_T31
Drug
UDCA
NCT02609048_inc_T32
Temporal
for the past twelve months
NCT02609048_inc_T33
Measurement
AP
NCT02609048_inc_T34
Value
≥ 1.67 × ULN
NCT02609048_inc_T35
Condition
reproductive potential
NCT02609048_inc_T36
Person
females
NCT02609048_inc_T37
Multiplier
at least one
NCT02609048_inc_T38
Device
barrier contraceptive
NCT02609048_inc_T39
Qualifier
second
NCT02609048_inc_T40
Device
birth control method
NCT02609048_inc_T41
Qualifier
effective
NCT02609048_inc_T43
Temporal
during the study
NCT02609048_inc_T44
Temporal
for at least two weeks after the last dose
NCT02609048_inc_T45
Reference_point
the last dose
NCT02609048_inc_T46
Scope
females of reproductive potential
NCT02609048_inc_T47
Scope
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
NCT02609048_inc_T48
Person
male
NCT02609048_inc_T49
Device
contraception
NCT02609048_inc_T50
Device
condoms
NCT02609048_inc_T51
Qualifier
appropriate
NCT02609048_inc_T53
Person
female
NCT02609048_inc_T54
Condition
reproductive potential
NCT02609048_inc_T55
Condition
pregnant
NCT02609048_inc_T56
Negation
not become
NCT02609048_inc_T57
Temporal
during the study
NCT02609048_inc_T58
Temporal
for at least two weeks after the last dose
NCT02609048_inc_T59
Reference_point
the last dose