Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis
NCT ID: NCT03018054
Last Updated: 2019-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2016-11-28
2019-08-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
NCT01221818
Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
NCT05061446
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
NCT04706793
A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
NCT03531892
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
NCT06049017
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
E6007 30 mg
Participants will receive E6007 30 milligrams (mg) once daily after breakfast.
E6007
once daily administration
E6007 60 mg
Participants will receive E6007 60 mg once daily after breakfast.
E6007
once daily administration
Placebo
Participants will receive matching placebo once daily after breakfast.
Placebo
once daily administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
E6007
once daily administration
Placebo
once daily administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EA Pharma Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
EA Pharma Trial Site #1
Nagakute, Aichi-ken, Japan
EA Pharma Trial Site #1
Nagoya, Aichi-ken, Japan
EA Pharma Trial Site #2
Nagoya, Aichi-ken, Japan
EA Pharma Trial Site #3
Nagoya, Aichi-ken, Japan
EA Pharma Trial Site #1
Toyoake, Aichi-ken, Japan
EA Pharma Trial Site #1
Toyota, Aichi-ken, Japan
EA Pharma Trial Site #1
Hirosaki, Aomori, Japan
EA Pharma Trial Site #2
Hirosaki, Aomori, Japan
EA Pharma Trial Site #1
Sakura, Chiba, Japan
EA Pharma Trial Site #1
Urayasu, Chiba, Japan
EA Pharma Trial Site #1
Matsuyama, Ehime, Japan
EA Pharma Trial Site #1
Ōgaki, Gifu, Japan
EA Pharma Trial Site #1
Takasaki, Gunma, Japan
EA Pharma Trial Site #1
Fukuyama, Hiroshima, Japan
EA Pharma Trial Site #1
Obihiro, Hokkaido, Japan
EA Pharma Trial Site #1
Sapporo, Hokkaido, Japan
EA Pharma Trial Site #2
Sapporo, Hokkaido, Japan
EA Pharma Trial Site #1
Nishinomiya, Hyōgo, Japan
EA Pharma Trial Site #1
Kanazawa, Ishikawa-ken, Japan
EA Pharma Trial Site #2
Kanazawa, Ishikawa-ken, Japan
EA Pharma Trial Site #1
Morioka, Iwate, Japan
EA Pharma Trial Site #1
Takamatsu, Kagawa-ken, Japan
EA Pharma Trial Site #2
Takamatsu, Kagawa-ken, Japan
EA Pharma Trial Site #1
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
Tsu, Mie-ken, Japan
EA Pharma Trial Site #1
Sendai, Miyagi, Japan
EA Pharma Trial Site #2
Sendai, Miyagi, Japan
EA Pharma Trial Site #1
Nagaoka, Niigata, Japan
EA Pharma Trial Site #1
Kurashiki, Okayama-ken, Japan
EA Pharma Trial Site #1
Sayama, Osaka, Japan
EA Pharma Trial Site #1
Suita, Osaka, Japan
EA Pharma Trial Site #1
Kawagoe, Saitama, Japan
EA Pharma Trial Site #1
Izumo, Shimane, Japan
EA Pharma Trial Site #1
Shimotsuga, Tochigi, Japan
EA Pharma Trial Site #1
Bunkyo, Tokyo, Japan
EA Pharma Trial Site #1
Chūō, Tokyo, Japan
EA Pharma Trial Site #1
Hachiōji, Tokyo, Japan
EA Pharma Trial Site #1
Minato, Tokyo, Japan
EA Pharma Trial Site #2
Minato, Tokyo, Japan
EA Pharma Trial Site #1
Mitaka, Tokyo, Japan
EA Pharma Trial Site #1
Shinagawa, Tokyo, Japan
EA Pharma Trial Site #1
Shinjuku, Tokyo, Japan
EA Pharma Trial Site #1
Ube, Yamaguchi, Japan
EA Pharma Trial Site #1
Kofu, Yamanashi, Japan
EA Pharma Trial Site #1
Chiba, , Japan
EA Pharma Trial Site #1
Fukuoka, , Japan
EA Pharma Trial Site #2
Fukuoka, , Japan
EA Pharma Trial Site #1
Hiroshima, , Japan
EA Pharma Trial Site #2
Hiroshima, , Japan
EA Pharma Trial Site #1
Kagoshima, , Japan
EA Pharma Trial Site #1
Kumamoto, , Japan
EA Pharma Trial Site #1
Kyoto, , Japan
EA Pharma Trial Site #2
Kyoto, , Japan
EA Pharma Trial Site #1
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 #2
Osaka, , Japan
EA Pharma Trial Site #1
Saga, , Japan
EA Pharma Trial Site #2
Saga, , Japan
EA Pharma Trial Site #1
Toyama, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E6007-J081-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.