Clinical Trial: Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Patients With Primary Biliary Cholangitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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

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 patients with primary biliary cholangitis (PBC).

Detailed Summary:
Sponsor: Arena Pharmaceuticals

Current Primary Outcome:

  • Change from baseline to Week 24 in serum ALP concentration. [ Time Frame: Week 24 ]
    Assess the change in ALP concentration following administration of APD334.
  • Number of patients with adverse events and abnormal clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis). [ Time Frame: Week 26 ]
    Safety and tolerability of APD334


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline to Week 12 in serum ALP concentration. [ Time Frame: Week 12 ]
    Assess the change in ALP concentration following administration of APD334.
  • Change from baseline to Week 12 and 24 in complete blood counts [ Time Frame: Weeks 12 and 24 ]
  • Change from baseline to Week 12 and 24 in quality of life [ Time Frame: Weeks 12 and 24 ]
    measured by the PBC-40 scale
  • Change from baseline to Week 12 and 24 in fatigue [ Time Frame: Weeks 12 and 24 ]
    measured by the PBC-40 scale
  • Change from baseline to Week 12 and 24 in pruritus [ Time Frame: Weeks 12 and 24 ]
    measured by the 5-D scale
  • Change from baseline to Week 12 and 24 in Schirmer test outcome [ Time Frame: Weeks 12 and 24 ]
    Schirmer test in patients with abnormal results at screening
  • Change from baseline to Week 12 and 24 in tear film break-up time [ Time Frame: Weeks 12 and 24 ]
    Tear film break-up time in patients with abnormal results at screening
  • Change from baseline to Week 12 and 24 in concentration of serum HsCRP [ Time Frame: Weeks 12 and 24 ]
  • Change from baseline to Week 12 and 24 in concentration of serum ALT [ Time Frame: Weeks 12 and 24 ]
  • Change from baseline to Week 12 and 24 in concentration of serum AST [ Time Frame: Weeks 12 and 24 ]
  • Change from baseline to Week 12 and 24 in concentration of serum GGT [ Time Frame: Weeks 12 and 24 ]
  • Change from baseline to Week 12 and 24 in concentration of serum C4 [ Time Frame: Weeks 12 and 24 ]
  • Change from baseline to Week 12 and 24 in concentration of serum immunoglobulin [ Time Frame: Weeks 12 and 24 ]
  • Change from baseline to Week 12 and 24 in concentration of serum GP73 [ Time Frame: Weeks 12 and 24 ]
  • Change from baseline to Week 12 and 24 in concentration of serum AMA [ Time Frame: Weeks 12 and 24 ]


Original Secondary Outcome: Same as current

Information By: Arena Pharmaceuticals

Dates:
Date Received: May 11, 2017
Date Started: May 2017
Date Completion: December 2018
Last Updated: May 15, 2017
Last Verified: May 2017