search
Back to results

Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid

Primary Purpose

Primary Biliary Cholangitis

Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
E6011
Placebo
Sponsored by
EA Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring E6011, Ursodeoxycholic acid, Japan

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with primary biliary cholangitis corresponding to one of the following criteria:

    • Histologically confirmed chronic non-suppurative destructive cholangitis (CNSDC) with laboratory findings compatible with primary biliary cholangitis (PBC)
    • Positivity for antimitochondrial antibodies (AMAs) with histological findings compatible with PBC but in the absence of characteristic histological findings of CNSDC
    • No histological findings available, but positivity for AMAs as well as clinical findings and a course indicative of typical cholestatic PBC
  • Aged ≥20 and <75 years old at the time of informed consent
  • Taking stable dose of ursodeoxycholic acid for at least 6 months (≥600 milligrams [mg]/day) prior to Screening
  • Screening and Week 0 alkaline phosphatase (ALP) values between 1.67 and 10 times the upper limit of normal
  • Outpatient
  • Has voluntarily consented, in writing, to participate in this study, and is able to comply with all aspects of the protocol

Exclusion Criteria:

  • Received the following drugs within 12 weeks before starting the study treatment:

    • Drugs that suppose the efficacy to PBC:

      o azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, penicillamine, fibrates, and other systemic corticosteroids

    • Potentially hepatotoxic drugs o methyl-dopa, sodium valproic acid, and isoniazide
  • History or current condition of hepatic decompensation with variceal bleeds, encephalopathy ≥ grade 2 and poorly controlled ascites, and history of liver transplantation
  • History or current condition of other concomitant liver diseases including hepatitis due to hepatitis B virus (HBV)/hepatitis C virus (HCV) infection, primary sclerosing cholangitis, alcoholic liver disease (including liver cirrhosis), autoimmune liver disease requiring the treatment of systemic corticosteroids or biopsy proven non-alcoholic steatohepatitis (NASH)
  • History or current clinical condition of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease, except for skin carcinoma (epithelial carcinoma or basal cell carcinoma) and cervix carcinoma which has completely excised and without metastasis or recurrence for more than 5 years before informed consent
  • Immunodeficiency or history of human immunodeficiency virus (HIV) infection
  • Infection requiring hospitalization or intravenous administration of antibiotics or disease requiring administration of antivirus drugs (eg, herpes zoster) within 4 weeks before starting the study treatment
  • History of tuberculosis or current complication of active tuberculosis
  • Positive tuberculosis test (QuantiFERON®TB Gold Test or T-SPOT®.TB Test) at Screening
  • History of clinically important vasculitis
  • History of severe allergy (shock or anaphylactoid symptoms)
  • Complication of uncontrolled disorders such as acute cardiac infarction, unstable angina, brain infarct, or symptomatic intracerebral hemorrhage
  • Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, or renal disease) that could affect the participant's safety or interfere with the study assessments in the opinion of the investigator or subinvestigator
  • Tested positive for any of the following at Screening: HIV, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, HBV deoxyribonucleic acid (DNA), HCV antibody, human T-lymphotropic virus type 1 (HTLV-1) antibody, or syphilis
  • Demonstrated prolonged QT interval corrected using Fridericia's formula (QTcF) interval (>450 milliseconds [ms]) in repeated electrocardiogram examinations
  • Received immunoglobulin preparations or blood products within 24 weeks before starting the study treatment
  • Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive
  • Females who are, or may be pregnant, who are breastfeeding, who wish to become pregnant during the study period, and females or their partners who do not wish to use reliable contraceptive measures.
  • Scheduled for surgery before Week 64
  • Has been treated with investigational drugs in other E6011 study
  • Currently enrolled in another clinical study, including the follow-up
  • Used any investigational drug within 28 days (or 5× the half-life, whichever is longer) before informed consent
  • Judged to be ineligible to participate in this study by the investigator or sub-investigator

Sites / Locations

  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site #1
  • EA Pharma trial site #2
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site #1
  • EA Pharma trial site #2
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site #1
  • EA Pharma trial site #2
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site #1
  • EA Pharma trial site #2
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site #1
  • EA Pharma trial site #2
  • EA Pharma trial site
  • EA Pharma trial site #1
  • EA Pharma trial site #2
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site
  • EA Pharma trial site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

low-dose, high-frequency E6011; high-dose, low-frequency E6011

low-dose, high-frequency E6011; low-dose, low-frequency E6011

high-dose, low-frequency E6011; high-dose, low-frequency E6011

high-dose, low-frequency E6011; low-dose, low-frequency E6011

low-dose, low-frequency E6011; high-dose, low-frequency E6011

low-dose, low-frequency E6011; low-dose, low-frequency E6011

Placebo; high-dose, low-frequency E6011

Placebo; low-dose, low-frequency E6011

Arm Description

Participants will receive low-dose E6011 at a relatively higher frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64.

Participants will receive low-dose E6011 at a relatively higher frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64.

Participants will receive high-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64.

Participants will receive high-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64.

Participants will receive low-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64.

Participants will receive low-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64.

Participants will receive placebo up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64.

Participants will receive placebo up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64.

Outcomes

Primary Outcome Measures

Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12
This assessment will be conducted as a measure of efficacy.

Secondary Outcome Measures

Number of participants with a decrease in ALP response rates of 15%, 20%, and 40% from Baseline
This assessment will be conducted as a measure of efficacy.
Number of participants with an ALP value less than 1.67 times the upper limit normal and a total bilirubin value within normal limits and a greater than or equal to 15% decrease in ALP from Baseline
This assessment will be conducted as a measure of efficacy.
Mean values of serum ALP, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at each visit
This assessment will be conducted as a measure of efficacy.
Mean values of gamma-guanosine-5'-triphosphate (γGTP) at each visit
This assessment will be conducted as a measure of efficacy.
Mean values of serum total bilirubin and direct bilirubin at each visit
This assessment will be conducted as a measure of efficacy.
Mean values of serum total bile acids at each visit
This assessment will be conducted as a measure of efficacy.
Mean values of serum albumin at each visit
This assessment will be conducted as a measure of efficacy.
Mean change from Baseline in serum ALP, AST, and ALT at each visit
This assessment will be conducted as a measure of efficacy.
Mean change from Baseline in serum γGTP at each visit
This assessment will be conducted as a measure of efficacy.
Mean change from Baseline in serum total bilirubin and direct bilirubin at each visit
This assessment will be conducted as a measure of efficacy.
Mean change from Baseline in serum total bile acids at each visit
This assessment will be conducted as a measure of efficacy.
Mean change from Baseline in serum albumin at each visit
This assessment will be conducted as a measure of efficacy.
Mean rate of change from Baseline in serum ALP, AST, and ALT at each visit
This assessment will be conducted as a measure of efficacy.
Mean rate of change from Baseline in serum γGTP at each visit
This assessment will be conducted as a measure of efficacy.
Mean rate of change from Baseline in serum total bilirubin and direct bilirubin at each visit
This assessment will be conducted as a measure of efficacy.
Mean rate of change from Baseline in serum total bile acids at each visit
This assessment will be conducted as a measure of efficacy.
Mean rate of change from Baseline in serum albumin at each visit
This assessment will be conducted as a measure of efficacy.
Mean change from Baseline in individual domain and total primary biliary cholangitis (PBC) version Child-Pugh scores
The Child-Pugh classification is used to assess the prognosis of chronic liver disease. The score employs five clinical measures of liver disease. Each measure is scored from 1 to 3, with 3 indicating most severe derangement. The total score ranges from 5 to 15 and is a sum of the individual domain scores. A higher score indicates a worse prognosis.
Mean change from Baseline in domain (Symptoms, Itch, Fatigue, Cognitive, Emotional, Social) and total scores on the PBC-40
The PBC-40 is measures quality of life. Participants are asked to respond to 40 questions, each of which is scored on a scale of 0 to 5 (where 0=not applicable; 1=least impact; 5=greatest impact), grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional). For each domain, scoring involves summing individual question response scores. A higher score indicates a poorer quality of life.
Mean change from Baseline in each score (fibrosis, bile duct loss, deposition of orcein-positive granules) and total scores, in the stage based on the total scores, in each score of cholangitis activity and hepatitis activity on Nakanuma classification
Scores for fibrosis, bile duct loss, and chronic cholestasis are combined for staging: stage 1, total score of 0; stage 2, score 1 to 3; stage 3, score 4 to 6; and stage 4, score 7 to 9. Cholangitis activity and hepatitis activity are graded as CA0-3 and HA0-3, respectively. A higher score indicates more severe disease.
Mean values of fibrosis marker at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Mean change from Baseline in fibrosis marker at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Mean rate of change from Baseline in fibrosis marker at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Mean values of fibrosis 4 (Fib-4) index at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Mean change from Baseline in Fib-4 index at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Mean rate of change from Baseline in Fib-4 index at each visit
The presence of serum fibrosis markers may be correlated with PBC.

Full Information

First Posted
March 24, 2017
Last Updated
January 3, 2019
Sponsor
EA Pharma Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03092765
Brief Title
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
Official Title
A Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision (non-safety related)
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
October 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EA Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis
Keywords
E6011, Ursodeoxycholic acid, Japan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low-dose, high-frequency E6011; high-dose, low-frequency E6011
Arm Type
Experimental
Arm Description
Participants will receive low-dose E6011 at a relatively higher frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64.
Arm Title
low-dose, high-frequency E6011; low-dose, low-frequency E6011
Arm Type
Experimental
Arm Description
Participants will receive low-dose E6011 at a relatively higher frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64.
Arm Title
high-dose, low-frequency E6011; high-dose, low-frequency E6011
Arm Type
Experimental
Arm Description
Participants will receive high-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64.
Arm Title
high-dose, low-frequency E6011; low-dose, low-frequency E6011
Arm Type
Experimental
Arm Description
Participants will receive high-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64.
Arm Title
low-dose, low-frequency E6011; high-dose, low-frequency E6011
Arm Type
Experimental
Arm Description
Participants will receive low-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64.
Arm Title
low-dose, low-frequency E6011; low-dose, low-frequency E6011
Arm Type
Experimental
Arm Description
Participants will receive low-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64.
Arm Title
Placebo; high-dose, low-frequency E6011
Arm Type
Experimental
Arm Description
Participants will receive placebo up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64.
Arm Title
Placebo; low-dose, low-frequency E6011
Arm Type
Experimental
Arm Description
Participants will receive placebo up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64.
Intervention Type
Drug
Intervention Name(s)
E6011
Intervention Description
Intravenous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous administration
Primary Outcome Measure Information:
Title
Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
Number of participants with a decrease in ALP response rates of 15%, 20%, and 40% from Baseline
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Number of participants with an ALP value less than 1.67 times the upper limit normal and a total bilirubin value within normal limits and a greater than or equal to 15% decrease in ALP from Baseline
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean values of serum ALP, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean values of gamma-guanosine-5'-triphosphate (γGTP) at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean values of serum total bilirubin and direct bilirubin at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean values of serum total bile acids at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean values of serum albumin at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in serum ALP, AST, and ALT at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in serum γGTP at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in serum total bilirubin and direct bilirubin at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in serum total bile acids at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in serum albumin at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean rate of change from Baseline in serum ALP, AST, and ALT at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean rate of change from Baseline in serum γGTP at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean rate of change from Baseline in serum total bilirubin and direct bilirubin at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean rate of change from Baseline in serum total bile acids at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean rate of change from Baseline in serum albumin at each visit
Description
This assessment will be conducted as a measure of efficacy.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in individual domain and total primary biliary cholangitis (PBC) version Child-Pugh scores
Description
The Child-Pugh classification is used to assess the prognosis of chronic liver disease. The score employs five clinical measures of liver disease. Each measure is scored from 1 to 3, with 3 indicating most severe derangement. The total score ranges from 5 to 15 and is a sum of the individual domain scores. A higher score indicates a worse prognosis.
Time Frame
Screening; up to Week 64
Title
Mean change from Baseline in domain (Symptoms, Itch, Fatigue, Cognitive, Emotional, Social) and total scores on the PBC-40
Description
The PBC-40 is measures quality of life. Participants are asked to respond to 40 questions, each of which is scored on a scale of 0 to 5 (where 0=not applicable; 1=least impact; 5=greatest impact), grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional). For each domain, scoring involves summing individual question response scores. A higher score indicates a poorer quality of life.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in each score (fibrosis, bile duct loss, deposition of orcein-positive granules) and total scores, in the stage based on the total scores, in each score of cholangitis activity and hepatitis activity on Nakanuma classification
Description
Scores for fibrosis, bile duct loss, and chronic cholestasis are combined for staging: stage 1, total score of 0; stage 2, score 1 to 3; stage 3, score 4 to 6; and stage 4, score 7 to 9. Cholangitis activity and hepatitis activity are graded as CA0-3 and HA0-3, respectively. A higher score indicates more severe disease.
Time Frame
Screening; Weeks 52 to 60
Title
Mean values of fibrosis marker at each visit
Description
The presence of serum fibrosis markers may be correlated with PBC.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in fibrosis marker at each visit
Description
The presence of serum fibrosis markers may be correlated with PBC.
Time Frame
Baseline; up to Week 64
Title
Mean rate of change from Baseline in fibrosis marker at each visit
Description
The presence of serum fibrosis markers may be correlated with PBC.
Time Frame
Baseline; up to Week 64
Title
Mean values of fibrosis 4 (Fib-4) index at each visit
Description
The presence of serum fibrosis markers may be correlated with PBC.
Time Frame
Baseline; up to Week 64
Title
Mean change from Baseline in Fib-4 index at each visit
Description
The presence of serum fibrosis markers may be correlated with PBC.
Time Frame
Baseline; up to Week 64
Title
Mean rate of change from Baseline in Fib-4 index at each visit
Description
The presence of serum fibrosis markers may be correlated with PBC.
Time Frame
Baseline; up to Week 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with primary biliary cholangitis corresponding to one of the following criteria: Histologically confirmed chronic non-suppurative destructive cholangitis (CNSDC) with laboratory findings compatible with primary biliary cholangitis (PBC) Positivity for antimitochondrial antibodies (AMAs) with histological findings compatible with PBC but in the absence of characteristic histological findings of CNSDC No histological findings available, but positivity for AMAs as well as clinical findings and a course indicative of typical cholestatic PBC Aged ≥20 and <75 years old at the time of informed consent Taking stable dose of ursodeoxycholic acid for at least 6 months (≥600 milligrams [mg]/day) prior to Screening Screening and Week 0 alkaline phosphatase (ALP) values between 1.67 and 10 times the upper limit of normal Outpatient Has voluntarily consented, in writing, to participate in this study, and is able to comply with all aspects of the protocol Exclusion Criteria: Received the following drugs within 12 weeks before starting the study treatment: Drugs that suppose the efficacy to PBC: o azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, penicillamine, fibrates, and other systemic corticosteroids Potentially hepatotoxic drugs o methyl-dopa, sodium valproic acid, and isoniazide History or current condition of hepatic decompensation with variceal bleeds, encephalopathy ≥ grade 2 and poorly controlled ascites, and history of liver transplantation History or current condition of other concomitant liver diseases including hepatitis due to hepatitis B virus (HBV)/hepatitis C virus (HCV) infection, primary sclerosing cholangitis, alcoholic liver disease (including liver cirrhosis), autoimmune liver disease requiring the treatment of systemic corticosteroids or biopsy proven non-alcoholic steatohepatitis (NASH) History or current clinical condition of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease, except for skin carcinoma (epithelial carcinoma or basal cell carcinoma) and cervix carcinoma which has completely excised and without metastasis or recurrence for more than 5 years before informed consent Immunodeficiency or history of human immunodeficiency virus (HIV) infection Infection requiring hospitalization or intravenous administration of antibiotics or disease requiring administration of antivirus drugs (eg, herpes zoster) within 4 weeks before starting the study treatment History of tuberculosis or current complication of active tuberculosis Positive tuberculosis test (QuantiFERON®TB Gold Test or T-SPOT®.TB Test) at Screening History of clinically important vasculitis History of severe allergy (shock or anaphylactoid symptoms) Complication of uncontrolled disorders such as acute cardiac infarction, unstable angina, brain infarct, or symptomatic intracerebral hemorrhage Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, or renal disease) that could affect the participant's safety or interfere with the study assessments in the opinion of the investigator or subinvestigator Tested positive for any of the following at Screening: HIV, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, HBV deoxyribonucleic acid (DNA), HCV antibody, human T-lymphotropic virus type 1 (HTLV-1) antibody, or syphilis Demonstrated prolonged QT interval corrected using Fridericia's formula (QTcF) interval (>450 milliseconds [ms]) in repeated electrocardiogram examinations Received immunoglobulin preparations or blood products within 24 weeks before starting the study treatment Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive Females who are, or may be pregnant, who are breastfeeding, who wish to become pregnant during the study period, and females or their partners who do not wish to use reliable contraceptive measures. Scheduled for surgery before Week 64 Has been treated with investigational drugs in other E6011 study Currently enrolled in another clinical study, including the follow-up Used any investigational drug within 28 days (or 5× the half-life, whichever is longer) before informed consent Judged to be ineligible to participate in this study by the investigator or sub-investigator
Facility Information:
Facility Name
EA Pharma trial site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
EA Pharma trial site
City
Matsudo
State/Province
Chiba
Country
Japan
Facility Name
EA Pharma trial site
City
Touon
State/Province
Ehime
Country
Japan
Facility Name
EA Pharma trial site
City
Yoshida
State/Province
Fukui
Country
Japan
Facility Name
EA Pharma trial site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
EA Pharma trial site
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
EA Pharma trial site #1
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
EA Pharma trial site #2
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
EA Pharma trial site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
EA Pharma trial site
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
EA Pharma trial site
City
Inashiki
State/Province
Ibaraki
Country
Japan
Facility Name
EA Pharma trial site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
EA Pharma trial site
City
Kita
State/Province
Kagawa
Country
Japan
Facility Name
EA Pharma trial site
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
EA Pharma trial site #1
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
EA Pharma trial site #2
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
EA Pharma trial site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
EA Pharma trial site
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
EA Pharma trial site
City
Oomura
State/Province
Nagasaki
Country
Japan
Facility Name
EA Pharma trial site
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
EA Pharma trial site
City
Nakagami
State/Province
Okinawa
Country
Japan
Facility Name
EA Pharma trial site
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
EA Pharma trial site #1
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
EA Pharma trial site #2
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
EA Pharma trial site
City
Ageo
State/Province
Saitama
Country
Japan
Facility Name
EA Pharma trial site
City
Iruma
State/Province
Saitama
Country
Japan
Facility Name
EA Pharma trial site
City
Shimotsuga
State/Province
Tochigi
Country
Japan
Facility Name
EA Pharma trial site
City
Bunkyo
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma trial site
City
Itabashi
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma trial site #1
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma trial site #2
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma trial site
City
Musashino
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma trial site
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma trial site #1
City
Fukuoka
Country
Japan
Facility Name
EA Pharma trial site #2
City
Fukuoka
Country
Japan
Facility Name
EA Pharma trial site
City
Fukushima
Country
Japan
Facility Name
EA Pharma trial site #1
City
Hiroshima
Country
Japan
Facility Name
EA Pharma trial site #2
City
Hiroshima
Country
Japan
Facility Name
EA Pharma trial site
City
Kagoshima
Country
Japan
Facility Name
EA Pharma trial site
City
Kumamoto
Country
Japan
Facility Name
EA Pharma trial site
City
Kyoto
Country
Japan
Facility Name
EA Pharma trial site
City
Niigata
Country
Japan
Facility Name
EA Pharma trial site
City
Okayama
Country
Japan
Facility Name
EA Pharma trial site
City
Osaka
Country
Japan
Facility Name
EA Pharma trial site
City
Saga
Country
Japan
Facility Name
EA Pharma trial site
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid

We'll reach out to this number within 24 hrs