A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel disease

Phase 1

• Conditions: Active Crohn’s disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-002109-70-CZ
• Lead Sponsor: EA Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-27
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects who meet all of the following criteria are eligible to participate in this clinical trial.
(1) Crohn’s disease patients aged 18 or over and under 65 on the date of consent.
(2) Patients 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.
(3) Patients with a baseline (at Week 0 before the start of IMP administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and 34.
(4) Patients with a Simple Endoscopic Score for Crohn’s Disease (SES-CD) = 7 (or for patients with isolated ileal disease, = 4 in ileum segment) 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.
(5) Patients who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient response) or the drugs were not tolerated (intolerance). Alternatively, patients who cannot taper adrenocorticosteroids (dependence). Alternatively, patients who showed no therapeutic response after administering biologic(s) (primary nonresponse), patients who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or patients who did not tolerate the drug (intolerance). (Detailed criteria are described in Attachment 7 and Attachment 8).
(6) If the patients are taking 1,200 kcal/day or less enteral nutrition, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
(7) If the patients 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.
(8) If the patients are taking under 30 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.
(9) If the patients 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.
(10) Patients who have received a sufficient explanation about the compliance rules of this clinical trial, who are willing to comply with them, and who are able to do so.
(11) Patients who voluntarily gave a written consent to participate in this clinical trial.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients diagnosed with ulcerative colitis or indeterminate colitis
Patients diagnosed with gastrointestinal epithelial dysplasia
Patients who have an abscess or are suspected to have one
Patients with an artificial anus, ileo-anal pouch or fistula
Patients with symptomatic or high-grade gastrointestinal stenosis
Patients who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult
Patients who have newly started seton drainage treatment within 12 weeks prior to the start of the IMP
Patients who have undergone bowel resection or a gastrointestinal surgery within 24 weeks prior to the start of the IMP administration
Patients who tested positive for C. difficile toxin test in the screening
Patients who tested positive for HIV, hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody, hepatitis B virus DNA, hepatitis C virus antibody, or human T cell leukemia virus type 1 antibody in the screening
Patients with positive or repeated indeterminate results on the TB test
Patients with findings showing a history of tuberculosis on a chest X-ray test in the screening period
Patients with findings of neurological symptoms such as motor impairment, cognitive disorder, language disorder or dysphagia in the evaluations during the screening period
Patients with a WBC count of less than 3,000/µL or blood CD4+ cell count under 200/µL in the screening tests
Patients with a medical history of clinically significant vasculitis
Acute myocardial infarction, unstable angina pectoris, cerebral infarction, and symptomatic cerebral haemorrhage patients
Patients whose AST or ALT was more than three times the UNL in the screening period tests or patients whose serum creatinine level was more than 1.5 times the UNL in the screening tests
Patients with a QTcF exceeding 450 ms repeatedly in standard 12-lead ECG tests in the screening period tests
Patients who have undergone cytoapheresis (granulocytapheresis) within 2 weeks prior to the start of the IMP
Hospitalisation within 4 weeks prior to the start of IMP, intravenous treatment of antibiotics, antiviral drugs within 4 weeks prior to the start of IMP or oral treatment of antibiotics, antiviral drugs within 2 weeks prior to the start of IMP. COVID-19: patients required hospitalization within 4 weeks prior to the start of the IMP, any intravenous treatment within 4 weeks prior to the start of the IMP or any oral treatment within 2 weeks prior to the start of IMP
Patients who received total parenteral nutrition, peripheral parenteral nutrition, or enteral nutrition exceeding 1200 kcal/day within 4 weeks prior to the start of the IMP
Patients who received =30 mg/day of oral prednisolone (or an equivalent adrenocorticosteroid), adrenocorticosteroid injection, enema or suppository within 4 weeks prior to the start of the IMP
Patients who received cyclosporine, mycophenolate mofetil, or tacrolimus within 8 weeks prior to the start of the IMP
Patients who received adalimumab, infliximab, certolizumab pegol, vedolizumab or ustekinumab within 8 weeks prior to the start of the IMP
Patients vaccinated with live vaccines within 12 weeks prior to the start of the IMP
Patients who received an immunoglobulin preparation or a blood product within 24 weeks prior to the start of the IMP administration
Patients who have received natalizumab or E6011 in the past
Patients with a history of

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified