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Trial record 1 of 1 for:    arena pharmaceuticals | PBC
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Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03155932
Recruitment Status : Terminated (Sponsor decision)
First Posted : May 16, 2017
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Biliary Cholangitis
Intervention Drug: APD334
Enrollment 2
Recruitment Details  
Pre-assignment Details Enrollment was planned for up to 20 participants. Two participants were enrolled into the study and completed 24 weeks of treatment.
Arm/Group Title APD334
Hide Arm/Group Description Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
Period Title: Overall Study
Started 2
Participants Escalated to 2 mg Dose of APD334 at Week 12 to Week 24 2
Completed 2
Not Completed 0
Arm/Group Title APD334
Hide Arm/Group Description Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female NA [1] 
Male NA [1] 
[1]
Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native NA [1] 
Asian NA [1] 
Native Hawaiian or Other Pacific Islander NA [1] 
Black or African American NA [1] 
White NA [1] 
More than one race NA [1] 
Unknown or Not Reported NA [1] 
[1]
Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.
1.Primary Outcome
Title Change in Serum Alkaline Phosphatase (ALP) Concentration
Hide Description Reduction in ALP concentration is a surrogate marker of slower disease progression.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
Arm/Group Title APD334
Hide Arm/Group Description:
Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants who were enrolled and received treatment in this study.
Arm/Group Title APD334
Hide Arm/Group Description:
Participants received APD334 1 mg tablet qd by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and PK data.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
3.Secondary Outcome
Title Change in Serum ALP Concentration
Hide Description Reduction in ALP concentration is a surrogate marker of slower disease progression.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
Arm/Group Title APD334
Hide Arm/Group Description:
Participants received APD334 1 mg tablet qd by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and PK data.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Pharmacokinetic Parameters of Etrasimod, and Its Metabolites
Hide Description [Not Specified]
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
Arm/Group Title APD334
Hide Arm/Group Description:
Participants received APD334 1 mg tablet qd by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and PK data.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Exploratory - Change in Complete Blood Count
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Exploratory - Change in Incidence of Fatigue as Assessed by Peripheral Biliary Cholangitis (PBC-40) Scale
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Exploratory - Change in Incidence of Pruritus as Assessed by 5-Dimensions (5-D) Itch Scale
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Exploratory - Change in Schirmer Test Outcome
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Exploratory - Change in Tear Film Break-Up Time
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Exploratory - Change in Concentration of Serum High Sensitivity C-Reactive Protein (hsCRP)
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Exploratory - Change in Concentration of Serum Alanine Transaminase (ALT)
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Exploratory - Change in Concentration of Serum Aspartate Transaminase (AST)
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Exploratory - Change in Concentration of Serum Gamma-Glutamyl Transferase (GGT)
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Exploratory - Change in Concentration of Serum C4
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Exploratory - Change in Concentration of Serum Immunoglobulin
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Exploratory - Change in Concentration of Serum GP73
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Exploratory - Change in Concentration of Serum Anti-Mitochondrial Antibodies (AMA)
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
18.Other Pre-specified Outcome
Title Exploratory - Change in Quality of Life
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 24
Outcome Measure Data Not Reported
Time Frame Up to Week 26
Adverse Event Reporting Description A TEAE was defined as any adverse events (AE) that were reported following study treatment administration and up to 2 weeks after the last treatment intake. An SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
 
Arm/Group Title APD334
Hide Arm/Group Description Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
All-Cause Mortality
APD334
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Serious Adverse Events
APD334
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
APD334
Affected / at Risk (%)
Total   2/2 (100.00%) 
Gastrointestinal disorders   
Loose stools  1  1/2 (50.00%) 
Lower abdominal cramps  1  1/2 (50.00%) 
General disorders   
Fatigue  1  1/2 (50.00%) 
Infections and infestations   
Urinary tract infection  1  1/2 (50.00%) 
Common cold - Upper respiratory tract infection  1  1/2 (50.00%) 
Investigations   
Elevated gamma-glutamyl transferase-worsening  1  1/2 (50.00%) 
Elevated alkaline phosphatase-worsening  1  1/2 (50.00%) 
Musculoskeletal and connective tissue disorders   
Worsening right hip pain  1  1/2 (50.00%) 
Olecranon bursitis  1  1/2 (50.00%) 
Back pain  1  1/2 (50.00%) 
Nervous system disorders   
Cognitive defects  1  1/2 (50.00%) 
Skin and subcutaneous tissue disorders   
Skin rash  1  1/2 (50.00%) 
Pruritus  1  1/2 (50.00%) 
1
Term from vocabulary, MedDra 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arena CT.gov Administrator
Organization: Arena Pharmaceuticals, Inc.
Phone: +1 855-218-9153
EMail: ct.gov@arenapharm.com
Layout table for additonal information
Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03155932    
Other Study ID Numbers: APD334-010
First Submitted: May 11, 2017
First Posted: May 16, 2017
Results First Submitted: January 28, 2022
Results First Posted: March 24, 2022
Last Update Posted: March 24, 2022