A Study of E6011 in Participants With Active Crohn's Disease

Study Purpose

The primary purpose of this study is to examine the efficacy and safety of E6011 after administration by means of double-blind placebo-controlled trial.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 64 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Has diagnosed on basis of clinical findings, endoscopic findings, etc. with small intestine-type, small and large-intestine type, or large-intestine type Crohn's disease at least 12 weeks before giving consent. 2. With a baseline (at week 0 before the start of investigational medicinal product [IMP] administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and 34. 3. With a SES-CD between 7 and 15 in the screening period, with one or more ulcers (in SES-CD score, ulcer presence subscore >= 1 in any segment) assessed by colonoscopy and confirmed by a centralised review. 4. Who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient response) or the drugs were not tolerated (intolerance). Alternatively, participants who cannot taper oral adrenocorticosteroids (dependence). Alternatively, participants who showed no therapeutic response after administering one biologic (primary nonresponse), participants who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or participants who did not tolerate the drug (intolerance). 5. If the participants are taking aminosalicylic acid (5-ASA), salazosulfapyridine, or antibiotics for the treatment of Crohn's disease (metronidazole, ciprofloxacin, etc.), the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration. 6. If the participants are taking under 30 milligram per day (mg/day) of oral prednisolone (or equivalent adrenocorticosteroid) or 9 mg/day or less of oral budesonide, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration. 7. If the participants are taking azathioprine (AZP), 6-mercaptopurine (6-MP) or methotrexate (MTX), the dosage and administration have not changed for at least 8 weeks prior to the start of the IMP administration.

Exclusion Criteria:

1. Diagnosed with ulcerative colitis or indeterminate colitis. 2. Diagnosed with gastrointestinal epithelial dysplasia. 3. Who have an abscess or are suspected to have one. 4. With an artificial anus, ileo-anal pouch or fistula. 5. With symptomatic or high-grade gastrointestinal stenosis (participants who require expansion by endoscopy or who require have SES-CD score stenosis sub-score of 3, etc.). 6. Who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03733314

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
EA Pharma Co., Ltd.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Japan

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn's Disease
Additional Details

Participants with moderate to severe Crohn's disease will be enrolled in this study. The study will include screening period, remission-induction period (double-blind), rescue period (open-label), extension period (open-label), post-observation period, and a follow-up period. At the end of remission-induction period, participants with reduction in Crohn's disease activity index (CDAI) score of 70 points or more when compared to baseline will move on to the open-label extension period, and participants with less than 70 points reduction in CDAI score will move on to the rescue period. At the end of the rescue period, participants with a reduction in the CDAI of 70 points or more will move on to the open-label extension period and with less than 70 points reduction in the CDAI score will be discontinued. The post-observation period will include in-person assessment after the completion or discontinuation of the extension period, and participants will be contacted by telephone, etc. after the last dose of study drug administration. Participants will be contacted over phone after the last dose of study drug administration for follow up assessments.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

E6011-ET2 Trial Site 5, Kagoshima, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 5

Kagoshima, ,

E6011-ET2 Trial Site 11, Gifu, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 11

Gifu, ,

E6011-ET2 Trial Site 1, Shinjuku, Tokyo, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 1

Shinjuku, Tokyo,

E6011-ET2 Trial Site 6, Mitakashi, Tokyo, Japan

Status

Not yet recruiting

Address

E6011-ET2 Trial Site 6

Mitakashi, Tokyo,

E6011-ET2 Trial Site 3, Minato, Tokyo, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 3

Minato, Tokyo,

E6011-ET2 Trial Site 2, Bunkyo, Tokyo, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 2

Bunkyo, Tokyo,

E6011-ET2 Trial Site 8, Takamatsu, Kagawa, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 8

Takamatsu, Kagawa,

E6011-ET2 Trial Site 7, Nishinomiya, Hyogo, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 7

Nishinomiya, Hyogo,

E6011-ET2 Trial Site 9, Ogaki, Gifu, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 9

Ogaki, Gifu,

E6011-ET2 Trial Site 10, Kashiwa, Chiba, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 10

Kashiwa, Chiba,

E6011-ET2 Trial Site 4, Nagoya, Aichi, Japan

Status

Recruiting

Address

E6011-ET2 Trial Site 4

Nagoya, Aichi,

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