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Clinical Trials/NCT03155932
NCT03155932
Terminated
Phase 2

An Open-label, Pilot, Proof of Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Etrasimod (APD334) in Patients With Primary Biliary Cholangitis

Arena Pharmaceuticals9 sites in 3 countries2 target enrollmentDecember 29, 2017
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ConditionsPrimary Biliary Cholangitis
InterventionsAPD334
DrugsAPD334

Overview

Phase
Phase 2
Intervention
APD334
Conditions
Primary Biliary Cholangitis
Sponsor
Arena Pharmaceuticals
Enrollment
2
Locations
9
Primary Endpoint
Change in Serum Alkaline Phosphatase (ALP) Concentration
Status
Terminated
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
December 29, 2017
End Date
January 31, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Arena Pharmaceuticals
Responsible Party
Sponsor

Eligibility Criteria

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
  • •Note: Other protocol defined Inclusion/Exclusion criteria may apply

Arms & Interventions

APD334

APD334 active treatment for 24 weeks.

Intervention: APD334

Outcomes

Primary Outcomes

Change in Serum Alkaline Phosphatase (ALP) Concentration

Time Frame: Baseline, Week 24

Reduction in ALP concentration is a surrogate marker of slower disease progression.

Number of Participants With Adverse Events

Time Frame: Up to Week 26

Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

Secondary Outcomes

  • Change in Serum ALP Concentration(Baseline, Week 12)
  • Pharmacokinetic Parameters of Etrasimod, and Its Metabolites(Up to Week 24)

Study Sites (9)

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