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Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

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: NCT03018054
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( EA Pharma Co., Ltd. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate Active Ulcerative Colitis Drug: E6007 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Parallel-Group, Placebo-Controlled Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis
Actual Study Start Date : November 28, 2016
Actual Primary Completion Date : April 17, 2019
Actual Study Completion Date : August 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from Baseline in Mayo score at 8 weeks [ Time Frame: Baseline; 8 weeks ]

Secondary Outcome Measures :
  1. Number of participants with abnormal, clinically significant laboratory values [ Time Frame: up to 8 weeks ]
  2. Change from Baseline in body temperature at 8 weeks [ Time Frame: Baseline; 8 weeks ]
  3. Change from Baseline in diastolic blood pressure and systolic blood pressure at 8 weeks [ Time Frame: Baseline; 8 weeks ]
  4. Change from Baseline in heart rate at 8 weeks [ Time Frame: Baseline; 8 weeks ]
  5. Change from Baseline in respiratory rate at 8 weeks [ Time Frame: Baseline; 8 weeks ]
  6. Change from Baseline in standard 12-lead electrocardiogram (ECG) values [ Time Frame: Baseline; 8 weeks ]
  7. Number of participants with abnormal, clinically significant chest X-ray findings [ Time Frame: up to 8 weeks ]
  8. Number of participants with any serious adverse event and number of participants with any non-serious adverse event [ Time Frame: up to 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018054


Locations
Show Show 64 study locations
Sponsors and Collaborators
EA Pharma Co., Ltd.
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Responsible Party: EA Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03018054    
Other Study ID Numbers: E6007-J081-201
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eisai Inc. ( EA Pharma Co., Ltd. ):
moderate active ulcerative colitis
Japanese
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases