♦Basic information
JapicCTI-No. JapicCTI-142543
♦Title of the study
Title of the study A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
Public title of the study A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
Primary sponsor EA Pharma Co.,Ltd.
Secondary sponsor  
Study Type interventional (drug)
Summary This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of E6011.
♦Details of the study
Disease or condition Crohn's Disease
Intervention
Intervention name E6011
Classification name(code) of the intervention 239 (other agents affecting digestive organs)
Dosage And administration of the intervention E6011 2 mg/kg, 5 mg/kg or 10 mg/kg intravenous infusion
Control intervention name  
Classification name(code) of the control intervention  
Dosage And administration of the control intervention  
Objectives of the study This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of E6011.
Study phase Phase 1E2
Study design multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study
Target sample size 18
Inclusion Criteria 1.Japanese patients aged 20 to 64 years old at the time of informed consent.
2.Diagnosed with Crohn's disease based on the diagnostic criteria for Crohn's disease of the Health and Labor Sciences Research Grants "Research on Measures against Intractable Diseases (Inflammatory Bowel Disease)" Group (2012).
3.Mild to Moderate severity at Observation Phase (150 less than or equal to CDAI less than 450, based on the above diagnostic criteria for Crohn's disease).
4.History of aminosalicylic acid (5-ASA), salazosulfapyridine, cortical steroid, immunomodulators, infliximab or adalimumab treatment with no apparent effect, or unable to continue the treatment due to AEs (except for infliximab and adalimumab)
5.Consent to use contraception (both the subject and the subject's partner), if the subject is a a man capable of reproduction or a woman of childbearing potential.
6.Has voluntarily consented, in writing, to participate in this study.
7.Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.


AgeF     20years old or more    64years old or less
SexF     Both
Exclusion Criteria 1.Abscess or suspected abscess found at Screening or Observation Phase (not applicable to perianal abscess).
2.Diagnosed with gastrointestinal epithelia dysplasia at Screening or Observation Phase.
3.Suspected of colitis other than Crohn's disease at Screening or Observation Phase (such as pseudomembranous colitis).
4.Symptomatic obstruction at Screening or Observation Phase.
5.Underwent intestinal resection within 24 weeks before the start of the study treatment, or planning to undergo intestinal resection in the next 52 weeks.
6.Newly started with Seaton drainage within 12 weeks before Observation Phase.
7.Diagnosed with short bowel syndrome at Screening or Observation Phase.
8.Positive C.Difficile toxin test at Screening.
9.Prior history or current complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
10.Immunodeficiency or history of HIV infection.
11.Infection requiring hospitalization or intravenous administration of antibiotics within 4 weeks before the start of the study treatment; or an infection requiring oral antibiotics within 2 weeks before the start of the study treatment.
12.History of tuberculosis or current complication of active tuberculosis.
13.History of serious allergy (shock, or anaphylactoid symptoms).
14.History of clinically important vascular edema, hematemesis, or hemoptysis.
15.History of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans.
16.History of clinically important vasculitis (such as mononeuritis multiplex).
17.In tests conducted at Screening, a positive finding for any of the following: human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus core antibody (HBc antibody), hepatitis B virus DNA (HBV DNA), hepatitis C virus antibody (HCV antibody), human T-lymphotrophic virus Type I antibody (HTLV-1 antibody), or syphilis screening. Except for the subject, if HBs antibody is only positive and is clear due to vaccination of Hepatitis B.
18.Any result other than negative in tuberculosis test (T-SPOT TB Test or QuantiFERON TB Gold Test) at Screening.
19.Findings indicating a history of tuberculosis on chest X-ray during screening.
20.Received a live vaccine within 12 weeks before starting the study treatment, or planning to receive a live vaccine before Week 52.
21.Planning to have surgery before Week 52.
22.Currently participating in another clinical trial, or used an investigational drug or investigational device, or participated in another clinical study, within 24 weeks of the start of the study treatment.
23.Judged to be ineligible to participate in this study by the investigator or subinvestigator.


Outcome
Primary Outcome safety and tolerability
Timepoints Adverse events (AEs ), Laboratory assessments, Vital signs and Electrocardiogram (ECG)
Secondary Outcome Pharmacokinetics (PK) profiles of repeated intravenous administration of E6011
Timepoints
Institutions
Duration of the study 2013-11-1  `  2018-3-31
Study status Ongoing
recruitment status Recruiting closed - ongoing study
Region Japan
♦Secondary ID
Related ID Name ClinicalTrials.gov ID
Related ID number NCT02039063
Related ID Name Other Study ID Number
Related ID number E6011-J081-101
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization EA Pharma Co.,Ltd.
Division Public Relations Group, Corporate Planning Dept.
Contact person or e-mail address etc. contact_ea@eapharma.co.jp
Organization@(Scientific)
Division@(Scientific)
Contact person or e-mail address etc.@(Scientific)
♦Other
Source funded
Name of research funds
Other
♦History
History
2017/4/28   revised
2017/3/10   revised
2016/3/10   revised
2015/8/21   revised
2014/7/23   revised
2014/6/24   revised
2014/5/22   application date