Last updated on June 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn's Disease
  • Age: Between 18 - 64 Years
  • Gender: Male or Female

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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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