Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-29

Study Completion Date

2019-01-31

Brief Summary

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The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).

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Detailed Description

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Conditions

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Primary Biliary Cholangitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APD334

APD334 active treatment for 24 weeks.

Group Type EXPERIMENTAL

APD334

Intervention Type DRUG

APD334 active treatment for 24 weeks.

Interventions

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APD334

APD334 active treatment for 24 weeks.

Intervention Type DRUG

Other Intervention Names

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etrasimod

Eligibility Criteria

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Inclusion Criteria

* Males or females aged 18 to 80 years (inclusive) at the time of screening, with confirmed Primary Biliary Cholangitis (PBC) diagnosis based upon at least 2 of 3 criteria:

* Anti-mitochondrial antibodies (AMA) titer \>1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies (anti-GP210 and/or anti-SP100)
* Alkaline phosphatase (ALP) \>1.5 x upper limit of normal (ULN) for at least 6 months
* Liver biopsy findings consistent with PBC
* Use of ursodeoxycholic acid (UDCA) for at least 6 months prior to screening (stable dose for at least 3 months immediately prior to screening)
* Participants must have ALP \>1.5 x ULN but \<10 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<5 x ULN, and total bilirubin \<ULN, at all screening visits
* AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are within 20% of each other

Exclusion Criteria

* Chronic liver disease of a non-PBC etiology. However, PBC participants accompanied with primary Sjögren's syndrome (pSS) are eligible to be enrolled.
* History or evidence of clinically significant hepatic decompensation
* Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
* Clinically significant infections within 6 weeks prior to treatment start, or infection with hepatitis C virus anytime in the past
* Immunosuppressive, immunomodulating, or investigational agents within 30 days prior to treatment start
* Treatment with obeticholic acid (OCA) within 30 days prior to Day 1

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No