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Moderate Active Ulcerative ColitisPhase 2NCT03018054

Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

A Phase 2 study testing E6007 in people with Moderate Active Ulcerative Colitis, run by EA Pharma Co., Ltd. at 64 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Moderate Active Ulcerative Colitis
What is being tested?
E6007
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
147 participants
Where
64 sitesJapan
Study dates
28 Nov 2016to 16 Aug 2019
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

Japan64 sites

  • EA Pharma Trial Site #1

    Bunkyo, Tokyo

  • EA Pharma Trial Site #1

    Chiba

  • EA Pharma Trial Site #1

    Chūō, Tokyo

  • EA Pharma Trial Site #1

    Fukuoka

  • EA Pharma Trial Site #2

    Fukuoka

  • EA Pharma Trial Site #1

    Fukuyama, Hiroshima

  • EA Pharma Trial Site #1

    Hachiōji, Tokyo

  • EA Pharma Trial Site #1

    Hirosaki, Aomori

  • EA Pharma Trial Site #2

    Hirosaki, Aomori

  • EA Pharma Trial Site #1

    Hiroshima

  • EA Pharma Trial Site #2

    Hiroshima

  • EA Pharma Trial Site #1

    Izumo, Shimane

  • EA Pharma Trial Site #1

    Kagoshima

  • EA Pharma Trial Site #1

    Kamakura, Kanagawa

  • EA Pharma Trial Site #1

    Kanazawa, Ishikawa-ken

  • EA Pharma Trial Site #2

    Kanazawa, Ishikawa-ken

  • EA Pharma Trial Site #1

    Kawagoe, Saitama

  • EA Pharma Trial Site #1

    Kawasaki, Kanagawa

  • EA Pharma Trial Site #1

    Kofu, Yamanashi

  • EA Pharma Trial Site #1

    Kumamoto

  • EA Pharma Trial Site #1

    Kurashiki, Okayama-ken

  • EA Pharma Trial Site #1

    Kyoto

  • EA Pharma Trial Site #2

    Kyoto

  • EA Pharma Trial Site #1

    Matsuyama, Ehime

  • EA Pharma Trial Site #1

    Minato, Tokyo

  • EA Pharma Trial Site #2

    Minato, Tokyo

  • EA Pharma Trial Site #1

    Mitaka, Tokyo

  • EA Pharma Trial Site #1

    Morioka, Iwate

  • EA Pharma Trial Site #1

    Nagakute, Aichi-ken

  • EA Pharma Trial Site #1

    Nagaoka, Niigata

  • EA Pharma Trial Site #1

    Nagasaki

  • EA Pharma Trial Site #1

    Nagoya, Aichi-ken

  • EA Pharma Trial Site #2

    Nagoya, Aichi-ken

  • EA Pharma Trial Site #3

    Nagoya, Aichi-ken

  • EA Pharma Trial Site #1

    Niigata

  • EA Pharma Trial Site #1

    Nishinomiya, Hyōgo

  • EA Pharma Trial Site #1

    Obihiro, Hokkaido

  • EA Pharma Trial Site #1

    Ōgaki, Gifu

  • EA Pharma Trial Site #1

    Okayama

  • EA Pharma Trial Site #1

    Osaka

  • EA Pharma Trial Site #2

    Osaka

  • EA Pharma Trial Site #1

    Saga

  • EA Pharma Trial Site #2

    Saga

  • EA Pharma Trial Site #1

    Sagamihara, Kanagawa

  • EA Pharma Trial Site #1

    Sakura, Chiba

  • EA Pharma Trial Site #1

    Sapporo, Hokkaido

  • EA Pharma Trial Site #2

    Sapporo, Hokkaido

  • EA Pharma Trial Site #1

    Sayama, Osaka

  • EA Pharma Trial Site #1

    Sendai, Miyagi

  • EA Pharma Trial Site #2

    Sendai, Miyagi

  • EA Pharma Trial Site #1

    Shimotsuga, Tochigi

  • EA Pharma Trial Site #1

    Shinagawa, Tokyo

  • EA Pharma Trial Site #1

    Shinjuku, Tokyo

  • EA Pharma Trial Site #1

    Suita, Osaka

  • EA Pharma Trial Site #1

    Takamatsu, Kagawa-ken

  • EA Pharma Trial Site #2

    Takamatsu, Kagawa-ken

  • EA Pharma Trial Site #1

    Takasaki, Gunma

  • EA Pharma Trial Site #1

    Toyama

  • EA Pharma Trial Site #1

    Toyoake, Aichi-ken

  • EA Pharma Trial Site #1

    Toyota, Aichi-ken

  • EA Pharma Trial Site #1

    Tsu, Mie-ken

  • EA Pharma Trial Site #1

    Ube, Yamaguchi

  • EA Pharma Trial Site #1

    Urayasu, Chiba

  • EA Pharma Trial Site #1

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: 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.

Being tested
E6007, Placebo
Keywords
moderate active ulcerative colitis, Japanese

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E6007Drug

    once daily administration

  • PlaceboDrug

    once daily administration

Study groups in NCT03018054
Study groupRoleWhat they receive
E6007 30 mgExperimentalParticipants will receive E6007 30 milligrams (mg) once daily after breakfast.
Receives: Drug: E6007
E6007 60 mgExperimentalParticipants will receive E6007 60 mg once daily after breakfast.
Receives: Drug: E6007
PlaceboPlacebo comparatorParticipants will receive matching placebo once daily after breakfast.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Mayo score at 8 weeks

    Measured: Baseline; 8 weeks

Secondary outcomes (8)

  1. Number of participants with abnormal, clinically significant laboratory values

    Measured: up to 8 weeks

  2. Change from Baseline in body temperature at 8 weeks

    Measured: Baseline; 8 weeks

  3. Change from Baseline in diastolic blood pressure and systolic blood pressure at 8 weeks

    Measured: Baseline; 8 weeks

  4. Change from Baseline in heart rate at 8 weeks

    Measured: Baseline; 8 weeks

  5. Change from Baseline in respiratory rate at 8 weeks

    Measured: Baseline; 8 weeks

  6. Change from Baseline in standard 12-lead electrocardiogram (ECG) values

    Measured: Baseline; 8 weeks

  7. Number of participants with abnormal, clinically significant chest X-ray findings

    Measured: up to 8 weeks

  8. Number of participants with any serious adverse event and number of participants with any non-serious adverse event

    Measured: up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study start28 Nov 2016
  3. Primary completion17 Apr 2019
  4. Study completion16 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018054
Sponsor's protocol ID
E6007-J081-201
Status last verified
Jul 2018
First submitted
10 Jan 2017
Last updated
4 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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