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