Clinical trial NCT03018054: Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis
Official title: A Phase 2, Double-Blind, Parallel-Group, Placebo-Controlled Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate Active Ulcerative Colitis
Keywords: moderate active ulcerative colitis
Japanese
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 147
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline in Mayo score at 8 weeks
timeFrame: Baseline; 8 weeks
Secondary outcomes:
measure: Number of participants with abnormal, clinically significant laboratory values
timeFrame: up to 8 weeks
measure: Change from Baseline in body temperature at 8 weeks
timeFrame: Baseline; 8 weeks
measure: Change from Baseline in diastolic blood pressure and systolic blood pressure at 8 weeks
timeFrame: Baseline; 8 weeks
measure: Change from Baseline in heart rate at 8 weeks
timeFrame: Baseline; 8 weeks
measure: Change from Baseline in respiratory rate at 8 weeks
timeFrame: Baseline; 8 weeks
measure: Change from Baseline in standard 12-lead electrocardiogram (ECG) values
timeFrame: Baseline; 8 weeks
measure: Number of participants with abnormal, clinically significant chest X-ray findings
timeFrame: up to 8 weeks
measure: Number of participants with any serious adverse event and number of participants with any non-serious adverse event
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Nagakute
country: Japan
facility: EA Pharma Trial Site #1
state: Aichi
city: Nagoya
country: Japan
facility: EA Pharma Trial Site #1
state: Aichi
city: Nagoya
country: Japan
facility: EA Pharma Trial Site #2
state: Aichi
city: Nagoya
country: Japan
facility: EA Pharma Trial Site #3
state: Aichi
city: Toyoake
country: Japan
facility: EA Pharma Trial Site #1
state: Aichi
city: Toyota
country: Japan
facility: EA Pharma Trial Site #1
state: Aichi
city: Hirosaki
country: Japan
facility: EA Pharma Trial Site #1
state: Aomori
city: Hirosaki
country: Japan
facility: EA Pharma Trial Site #2
state: Aomori
city: Sakura
country: Japan
facility: EA Pharma Trial Site #1
state: Chiba
city: Urayasu
country: Japan
facility: EA Pharma Trial Site #1
state: Chiba
city: Matsuyama
country: Japan
facility: EA Pharma Trial Site #1
state: Ehime
city: Ogaki
country: Japan
facility: EA Pharma Trial Site #1
state: Gifu
city: Takasaki
country: Japan
facility: EA Pharma Trial Site #1
state: Gunma
city: Fukuyama
country: Japan
facility: EA Pharma Trial Site #1
state: Hiroshima
city: Obihiro
country: Japan
facility: EA Pharma Trial Site #1
state: Hokkaido
city: Sapporo
country: Japan
facility: EA Pharma Trial Site #1
state: Hokkaido
city: Sapporo
country: Japan
facility: EA Pharma Trial Site #2
state: Hokkaido
city: Nishinomiya
country: Japan
facility: EA Pharma Trial Site #1
state: Hyogo
city: Kanazawa
country: Japan
facility: EA Pharma Trial Site #1
state: Ishikawa
city: Kanazawa
country: Japan
facility: EA Pharma Trial Site #2
state: Ishikawa
city: Morioka
country: Japan
facility: EA Pharma Trial Site #1
state: Iwate
city: Takamatsu
country: Japan
facility: EA Pharma Trial Site #1
state: Kagawa
city: Takamatsu
country: Japan
facility: EA Pharma Trial Site #2
state: Kagawa
city: Kamakura
country: Japan
facility: EA Pharma Trial Site #1
state: Kanagawa
city: Kawasaki
country: Japan
facility: EA Pharma Trial Site #1
state: Kanagawa
city: Sagamihara
country: Japan
facility: EA Pharma Trial Site #1
state: Kanagawa
city: Yokohama
country: Japan
facility: EA Pharma Trial Site #1
state: Kanagawa
city: Tsu
country: Japan
facility: EA Pharma Trial Site #1
state: Mie
city: Sendai
country: Japan
facility: EA Pharma Trial Site #1
state: Miyagi
city: Sendai
country: Japan
facility: EA Pharma Trial Site #2
state: Miyagi
city: Nagaoka
country: Japan
facility: EA Pharma Trial Site #1
state: Niigata
city: Kurashiki
country: Japan
facility: EA Pharma Trial Site #1
state: Okayama
city: Osakasayama
country: Japan
facility: EA Pharma Trial Site #1
state: Osaka
city: Suita
country: Japan
facility: EA Pharma Trial Site #1
state: Osaka
city: Kawagoe
country: Japan
facility: EA Pharma Trial Site #1
state: Saitama
city: Izumo
country: Japan
facility: EA Pharma Trial Site #1
state: Shimane
city: Shimotsuga
country: Japan
facility: EA Pharma Trial Site #1
state: Tochigi
city: Bunkyo
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Chuo
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Hachioji
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Minato
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Minato
country: Japan
facility: EA Pharma Trial Site #2
state: Tokyo
city: Mitaka
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Shinagawa
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Shinjuku
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Ube
country: Japan
facility: EA Pharma Trial Site #1
state: Yamaguchi
city: Kofu
country: Japan
facility: EA Pharma Trial Site #1
state: Yamanashi
city: Chiba
country: Japan
facility: EA Pharma Trial Site #1
city: Fukuoka
country: Japan
facility: EA Pharma Trial Site #1
city: Fukuoka
country: Japan
facility: EA Pharma Trial Site #2
city: Hiroshima
country: Japan
facility: EA Pharma Trial Site #1
city: Hiroshima
country: Japan
facility: EA Pharma Trial Site #2
city: Kagoshima
country: Japan
facility: EA Pharma Trial Site #1
city: Kumamoto
country: Japan
facility: EA Pharma Trial Site #1
city: Kyoto
country: Japan
facility: EA Pharma Trial Site #1
city: Kyoto
country: Japan
facility: EA Pharma Trial Site #2
city: Nagasaki
country: Japan
facility: EA Pharma Trial Site #1
city: Niigata
country: Japan
facility: EA Pharma Trial Site #1
city: Okayama
country: Japan
facility: EA Pharma Trial Site #1
city: Osaka
country: Japan
facility: EA Pharma Trial Site #1
city: Osaka
country: Japan
facility: EA Pharma Trial Site #2
city: Saga
country: Japan
facility: EA Pharma Trial Site #1
city: Saga
country: Japan
facility: EA Pharma Trial Site #2
city: Toyama
country: Japan
facility: EA Pharma Trial Site #1
Study officials:
References: