Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

October 3, 2019 updated by: EA Pharma Co., Ltd.

A Phase 2, Double-Blind, Parallel-Group, Placebo-Controlled Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg), E6007 60 mg or placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
        • EA Pharma Trial Site #1
      • Fukuoka, Japan
        • EA Pharma Trial Site #1
      • Fukuoka, Japan
        • EA Pharma Trial Site #2
      • Hiroshima, Japan
        • EA Pharma Trial Site #1
      • Hiroshima, Japan
        • EA Pharma Trial Site #2
      • Kagoshima, Japan
        • EA Pharma Trial Site #1
      • Kumamoto, Japan
        • EA Pharma Trial Site #1
      • Kyoto, Japan
        • EA Pharma Trial Site #1
      • Kyoto, Japan
        • EA Pharma Trial Site #2
      • Nagasaki, Japan
        • EA Pharma Trial Site #1
      • Niigata, Japan
        • EA Pharma Trial Site #1
      • Okayama, Japan
        • EA Pharma Trial Site #1
      • Osaka, Japan
        • EA Pharma Trial Site #1
      • Osaka, Japan
        • EA Pharma Trial Site #2
      • Saga, Japan
        • EA Pharma Trial Site #1
      • Saga, Japan
        • EA Pharma Trial Site #2
      • Toyama, Japan
        • EA Pharma Trial Site #1
    • Aichi
      • Nagakute, Aichi, Japan
        • EA Pharma Trial Site #1
      • Nagoya, Aichi, Japan
        • EA Pharma Trial Site #1
      • Nagoya, Aichi, Japan
        • EA Pharma Trial Site #2
      • Nagoya, Aichi, Japan
        • EA Pharma Trial Site #3
      • Toyoake, Aichi, Japan
        • EA Pharma Trial Site #1
      • Toyota, Aichi, Japan
        • EA Pharma Trial Site #1
    • Aomori
      • Hirosaki, Aomori, Japan
        • EA Pharma Trial Site #1
      • Hirosaki, Aomori, Japan
        • EA Pharma Trial Site #2
    • Chiba
      • Sakura, Chiba, Japan
        • EA Pharma Trial Site #1
      • Urayasu, Chiba, Japan
        • EA Pharma Trial Site #1
    • Ehime
      • Matsuyama, Ehime, Japan
        • EA Pharma Trial Site #1
    • Gifu
      • Ogaki, Gifu, Japan
        • EA Pharma Trial Site #1
    • Gunma
      • Takasaki, Gunma, Japan
        • EA Pharma Trial Site #1
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • EA Pharma Trial Site #1
    • Hokkaido
      • Obihiro, Hokkaido, Japan
        • EA Pharma Trial Site #1
      • Sapporo, Hokkaido, Japan
        • EA Pharma Trial Site #1
      • Sapporo, Hokkaido, Japan
        • EA Pharma Trial Site #2
    • Hyogo
      • Nishinomiya, Hyogo, Japan
        • EA Pharma Trial Site #1
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • EA Pharma Trial Site #1
      • Kanazawa, Ishikawa, Japan
        • EA Pharma Trial Site #2
    • Iwate
      • Morioka, Iwate, Japan
        • EA Pharma Trial Site #1
    • Kagawa
      • Takamatsu, Kagawa, Japan
        • EA Pharma Trial Site #1
      • Takamatsu, Kagawa, Japan
        • EA Pharma Trial Site #2
    • Kanagawa
      • Kamakura, Kanagawa, Japan
        • EA Pharma Trial Site #1
      • Kawasaki, Kanagawa, Japan
        • EA Pharma Trial Site #1
      • Sagamihara, Kanagawa, Japan
        • EA Pharma Trial Site #1
      • Yokohama, Kanagawa, Japan
        • EA Pharma Trial Site #1
    • Mie
      • Tsu, Mie, Japan
        • EA Pharma Trial Site #1
    • Miyagi
      • Sendai, Miyagi, Japan
        • EA Pharma Trial Site #1
      • Sendai, Miyagi, Japan
        • EA Pharma Trial Site #2
    • Niigata
      • Nagaoka, Niigata, Japan
        • EA Pharma Trial Site #1
    • Okayama
      • Kurashiki, Okayama, Japan
        • EA Pharma Trial Site #1
    • Osaka
      • Osakasayama, Osaka, Japan
        • EA Pharma Trial Site #1
      • Suita, Osaka, Japan
        • EA Pharma Trial Site #1
    • Saitama
      • Kawagoe, Saitama, Japan
        • EA Pharma Trial Site #1
    • Shimane
      • Izumo, Shimane, Japan
        • EA Pharma Trial Site #1
    • Tochigi
      • Shimotsuga, Tochigi, Japan
        • EA Pharma Trial Site #1
    • Tokyo
      • Bunkyo, Tokyo, Japan
        • EA Pharma Trial Site #1
      • Chuo, Tokyo, Japan
        • EA Pharma Trial Site #1
      • Hachioji, Tokyo, Japan
        • EA Pharma Trial Site #1
      • Minato, Tokyo, Japan
        • EA Pharma Trial Site #1
      • Minato, Tokyo, Japan
        • EA Pharma Trial Site #2
      • Mitaka, Tokyo, Japan
        • EA Pharma Trial Site #1
      • Shinagawa, Tokyo, Japan
        • EA Pharma Trial Site #1
      • Shinjuku, Tokyo, Japan
        • EA Pharma Trial Site #1
    • Yamaguchi
      • Ube, Yamaguchi, Japan
        • EA Pharma Trial Site #1
    • Yamanashi
      • Kofu, Yamanashi, Japan
        • EA Pharma Trial Site #1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese participants aged from 20 to 74 years at the time of informed consent
  • Participants with a diagnosis based on the Revised Diagnostic Criteria for Ulcerative Colitis (UC) issued by the Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2013) at least 4 weeks before the start of administration of study drug
  • Active UC participants as determined by Baseline complete Mayo score of 6 to 10 points with an endoscopic subscore of ≥2 and a rectal bleeding subscore of ≥1
  • Participants who are currently being treated with oral 5-ASA or immunomodulator or corticosteroid with inadequate response or intolerance, or are corticosteroid dependent
  • Participants being seen on an outpatient basis
  • Has voluntarily consented, in writing, to participate in this study and is able and willing to comply with the requirements of this study protocol

Exclusion Criteria:

  • Reduction in partial Mayo score of ≥3 points at Baseline from Screening
  • Diagnosed with right-sided or segmental colitis, and proctitis from a Baseline endoscopy
  • Received any anti-tumor necrosis factor (TNF) agent for over 2 years, or within 12 weeks prior to Baseline
  • History of colectomy, or planning to have surgery for treatment of UC at Screening or Baseline
  • White blood cell count below 3000/microliters (µL) at Screening
  • History or suspected history of central nervous system disorder found at Screening or Baseline
  • Current complication or suspected malignancy or toxic megacolon at Screening or Baseline
  • Prior history or current complication of colonic dysplasia at Screening or Baseline
  • History of any severe drug allergy at Screening or Baseline
  • Received a live vaccine within 4 weeks prior to Baseline
  • QTc repeatedly above 450 milliseconds (ms) on the electrocardiogram (ECG) test at Screening
  • In the case of women: nursing mothers or pregnant women at Screening or Baseline
  • Refusal to use medically suitable contraception (both the participant and the participant's partner) throughout the entire study period, if the participant is a man capable of reproduction or a woman of childbearing potential
  • Female participants who want to become pregnant or male participants whose partners want to become pregnant throughout the entire study period
  • Evidence of clinically significant disease that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments at Screening or Baseline
  • History of any medical conditions or concomitant medical conditions that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study at Screening or Baseline
  • A positive finding on the human immunodeficiency virus antigen and antibody test at Screening
  • In tests conducted at Screening, a positive finding for any of the following: hepatitis B virus surface antigen, hepatitis B virus surface antibody, hepatitis B virus core antibody, or hepatitis C virus antibody
  • Any result other than negative on the tuberculosis test at Screening
  • Findings indicating a history of tuberculosis on chest X-ray during Screening
  • History of drug or alcohol dependency or abuse within approximately the last 2 years prior to Screening or Baseline
  • Use of illegal recreational drugs at Screening or Baseline
  • Currently enrolled in another clinical trial or used any investigational drug or device within 16 weeks preceding informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: E6007 30 mg
Participants will receive E6007 30 milligrams (mg) once daily after breakfast.
Drug: E6007
once daily administration
EXPERIMENTAL: E6007 60 mg
Participants will receive E6007 60 mg once daily after breakfast.
Drug: E6007
once daily administration
PLACEBO_COMPARATOR: Placebo
Participants will receive matching placebo once daily after breakfast.
Drug: Placebo
once daily administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Mayo score at 8 weeks
Time Frame: Baseline; 8 weeks
Baseline; 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with abnormal, clinically significant laboratory values
Time Frame: up to 8 weeks
up to 8 weeks
Change from Baseline in body temperature at 8 weeks
Time Frame: Baseline; 8 weeks
Baseline; 8 weeks
Change from Baseline in diastolic blood pressure and systolic blood pressure at 8 weeks
Time Frame: Baseline; 8 weeks
Baseline; 8 weeks
Change from Baseline in heart rate at 8 weeks
Time Frame: Baseline; 8 weeks
Baseline; 8 weeks
Change from Baseline in respiratory rate at 8 weeks
Time Frame: Baseline; 8 weeks
Baseline; 8 weeks
Change from Baseline in standard 12-lead electrocardiogram (ECG) values
Time Frame: Baseline; 8 weeks
Baseline; 8 weeks
Number of participants with abnormal, clinically significant chest X-ray findings
Time Frame: up to 8 weeks
up to 8 weeks
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Time Frame: up to 8 weeks
up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EA Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E6007-J081-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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