Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

NCT03018054 | Completed Phase 2 DMC

• 1 other identifier: E6007-J081-201
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 64

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.

Conditions

Moderate Active Ulcerative Colitis

Keywords

moderate active ulcerative colitis; Japanese

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Mayo score at 8 weeks

  Baseline; 8 weeks

Secondary Outcomes (8)

• Number of participants with abnormal, clinically significant laboratory values

  up to 8 weeks

• Change from Baseline in body temperature at 8 weeks

  Baseline; 8 weeks

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

  Baseline; 8 weeks

• Change from Baseline in heart rate at 8 weeks

  Baseline; 8 weeks

• Change from Baseline in respiratory rate at 8 weeks

  Baseline; 8 weeks

Study Arms (3)

E6007 30 mg

EXPERIMENTAL

Participants will receive E6007 30 milligrams (mg) once daily after breakfast.

Drug: E6007

E6007 60 mg

EXPERIMENTAL

Participants will receive E6007 60 mg once daily after breakfast.

Drug: E6007

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo once daily after breakfast.

Drug: Placebo

Interventions

E6007 DRUG

once daily administration

E6007 30 mg; E6007 60 mg

Placebo DRUG

once daily administration

Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EA Pharma Co., Ltd.: lead

Study Sites (64)

EA Pharma Trial Site #1

Nagakute, Aichi-ken, Japan

Location

EA Pharma Trial Site #1

Nagoya, Aichi-ken, Japan

Location

EA Pharma Trial Site #2

Nagoya, Aichi-ken, Japan

Location

EA Pharma Trial Site #3

Nagoya, Aichi-ken, Japan

Location

EA Pharma Trial Site #1

Toyoake, Aichi-ken, Japan

Location

EA Pharma Trial Site #1

Toyota, Aichi-ken, Japan

Location

EA Pharma Trial Site #1

Hirosaki, Aomori, Japan

Location

EA Pharma Trial Site #2

Hirosaki, Aomori, Japan

Location

EA Pharma Trial Site #1

Sakura, Chiba, Japan

Location

EA Pharma Trial Site #1

Urayasu, Chiba, Japan

Location

EA Pharma Trial Site #1

Matsuyama, Ehime, Japan

Location

EA Pharma Trial Site #1

Ōgaki, Gifu, Japan

Location

EA Pharma Trial Site #1

Takasaki, Gunma, Japan

Location

EA Pharma Trial Site #1

Fukuyama, Hiroshima, Japan

Location

EA Pharma Trial Site #1

Obihiro, Hokkaido, Japan

Location

EA Pharma Trial Site #1

Sapporo, Hokkaido, Japan

Location

EA Pharma Trial Site #2

Sapporo, Hokkaido, Japan

Location

EA Pharma Trial Site #1

Nishinomiya, Hyōgo, Japan

Location

EA Pharma Trial Site #1

Kanazawa, Ishikawa-ken, Japan

Location

EA Pharma Trial Site #2

Kanazawa, Ishikawa-ken, Japan

Location

EA Pharma Trial Site #1

Morioka, Iwate, Japan

Location

EA Pharma Trial Site #1

Takamatsu, Kagawa-ken, Japan

Location

EA Pharma Trial Site #2

Takamatsu, Kagawa-ken, Japan

Location

EA Pharma Trial Site #1

Kamakura, Kanagawa, Japan

Location

EA Pharma Trial Site #1

Kawasaki, Kanagawa, Japan

Location

EA Pharma Trial Site #1

Sagamihara, Kanagawa, Japan

Location

EA Pharma Trial Site #1

Yokohama, Kanagawa, Japan

Location

EA Pharma Trial Site #1

Tsu, Mie-ken, Japan

Location

EA Pharma Trial Site #1

Sendai, Miyagi, Japan

Location

EA Pharma Trial Site #2

Sendai, Miyagi, Japan

Location

EA Pharma Trial Site #1

Nagaoka, Niigata, Japan

Location

EA Pharma Trial Site #1

Kurashiki, Okayama-ken, Japan

Location

EA Pharma Trial Site #1

Sayama, Osaka, Japan

Location

EA Pharma Trial Site #1

Suita, Osaka, Japan

Location

EA Pharma Trial Site #1

Kawagoe, Saitama, Japan

Location

EA Pharma Trial Site #1

Izumo, Shimane, Japan

Location

EA Pharma Trial Site #1

Shimotsuga, Tochigi, Japan

Location

EA Pharma Trial Site #1

Bunkyo, Tokyo, Japan

Location

EA Pharma Trial Site #1

Chūō, Tokyo, Japan

Location

EA Pharma Trial Site #1

Hachiōji, Tokyo, Japan

Location

EA Pharma Trial Site #1

Minato, Tokyo, Japan

Location

EA Pharma Trial Site #2

Minato, Tokyo, Japan

Location

EA Pharma Trial Site #1

Mitaka, Tokyo, Japan

Location

EA Pharma Trial Site #1

Shinagawa, Tokyo, Japan

Location

EA Pharma Trial Site #1

Shinjuku, Tokyo, Japan

Location

EA Pharma Trial Site #1

Ube, Yamaguchi, Japan

Location

EA Pharma Trial Site #1

Kofu, Yamanashi, Japan

Location

EA Pharma Trial Site #1

Chiba, Japan

Location

EA Pharma Trial Site #1

Fukuoka, Japan

Location

EA Pharma Trial Site #2

Fukuoka, Japan

Location

EA Pharma Trial Site #1

Hiroshima, Japan

Location

EA Pharma Trial Site #2

Hiroshima, Japan

Location

EA Pharma Trial Site #1

Kagoshima, Japan

Location

EA Pharma Trial Site #1

Kumamoto, Japan

Location

EA Pharma Trial Site #1

Kyoto, Japan

Location

EA Pharma Trial Site #2

Kyoto, Japan

Location

EA Pharma Trial Site #1

Nagasaki, Japan

Location

EA Pharma Trial Site #1

Niigata, Japan

Location

EA Pharma Trial Site #1

Okayama, Japan

Location

EA Pharma Trial Site #1

Osaka, Japan

Location

EA Pharma Trial Site #2

Osaka, Japan

Location

EA Pharma Trial Site #1

Saga, Japan

Location

EA Pharma Trial Site #2

Saga, Japan

Location

EA Pharma Trial Site #1

Toyama, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: November 28, 2016
• Primary Completion: April 17, 2019
• Study Completion: August 16, 2019
• Last Updated: October 4, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (64)