A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT02039063
• Date of registration: 09/01/2014
• Prospective Registration: Yes
• Primary sponsor: EA Pharma Co., Ltd.
• Public title: A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
• Scientific title: A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
• Date of first enrolment: March 14, 2014
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02039063
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment.
• Phase: Phase 1/Phase 2

Countries of recruitment

Japan

Key inclusion & exclusion criteria

Inclusion Criteria

Subjects must meet all of the following criteria to be included in this study:

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 (CDAI between 150 and 450, based on the
above diagnosis criteria for Crohn's disease).

4. History of aminosalycylic 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.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

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
sub-investigator



Age minimum: 20 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: E6011 15 mg/kg

Drug: E6011 5 mg/kg

Drug: E6011 10 mg/kg

Drug: E6011 2 mg/kg

Primary Outcome(s)

Electrocardiogram (ECG) as a measure of safety and tolerability [Time Frame: Baseline and Week 12]

Adverse events (AEs) as a measure of safety and tolerability [Time Frame: Baseline and Week 12]

Laboratory assessments as a measure of safety and tolerability [Time Frame: Baseline and Week 12]

Vital signs as a measure of safety and tolerability [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Pharmacokinetics (PK) profiles of repeated intravenous administration of E6011 [Time Frame: Baseline and Week 12]

Secondary ID(s)

E6011-J081-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors