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


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Verified May 2017 by Arena Pharmaceuticals

Sponsor:

Information provided by (Responsible Party):

Arena Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03155932

First received: May 11, 2017

Last updated: May 15, 2017

Last verified: May 2017

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).

Primary Biliary Cholangitis Drug: APD334 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:

Open label

Masking: No masking
Primary Purpose: Treatment

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

Primary Outcome Measures:

Secondary Outcome Measures:

  • 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 ]

Estimated Enrollment: 20
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Experimental: APD334

APD334 active treatment for 24 weeks.

Drug: APD334

APD334 active treatment for 24 weeks.

Other Name: etrasimod

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

Key Exclusion Criteria:

  • Chronic liver disease of a non-PBC etiology
  • History or evidence of clinically significant severe hepatic or renal impairment
  • 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 OCA within 30 days prior to treatment start

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03155932

Arena Pharmaceuticals

Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03155932     History of Changes
Other Study ID Numbers: APD334-010
Study First Received: May 11, 2017
Last Updated: May 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2017