Early phase 2 clinical trial of E6011 in patients with active Crohn's disease
- Conditions
- Crohn's Disease
- Registration Number
- JPRN-jRCT2080224078
- Lead Sponsor
- EA Pharma Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 40
(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 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) 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.
(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 oral adrenocorticosteroids (dependence). Alternatively, patients who showed no therapeutic response after administering one biologic (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).
(1) Patients diagnosed with ulcerative colitis or indeterminate colitis.
(2) Patients diagnosed with gastric epithelial dysplasia.
(3) Patients who have an abscess or are suspected to have one.
(4) Patients with an artificial anus, ileo-anal pouch or fistula.
(5) Patients with symptomatic or high-grade gastrointestinal stenosis.
(6) Patients who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.
(7) Patients who tested positive for C.difficile toxin test in the screening period.
(8) Patients who tested positive for HIV, HBsAg, anti-HBs, anti-HBc, HBV-DNA, anti-HCV, or anti-HTLV-1 in the screening period.
(9) Patients with positive or repeated indeterminate (inconclusive) results on the TB test.
(10) Patients with findings showing a history of tuberculosis on a chest X-ray test in the screening period.
(11) Patients with findings of neurological symptoms such as motor impairment, cognitive disorder, language disorder or dysphagia in the evaluations during the screening period.
(12) Patients with a WBC count of less than 3,000/micro-L or blood CD4-positive cell count under 200/micro-L in the screening period tests.
(13) Patients with a medical history of clinically significant vasculitis.
(14) Acute myocardial infarction, unstable angina pectoris, cerebral infarction, and symptomatic cerebral haemorrhage patients.
(15) Patients whose AST or ALT was more than twice the upper normal limit in the screening period tests or patients whose serum creatinine level exceeded 1.5 mg/dL in the screening period tests.
(16) Patients with a QTcF exceeding 450 ms repeatedly in standard 12-lead ECG tests in the screening period tests.
(17) Patients with a history of a malignant tumour, lymphoma, leukemia, or lymphoproliferative disorders.
(18) Patients with immunodeficiency or a history of HIV infection.
(19) Patients with a history of severe allergy
(20) Patients currently taking part in another clinical trial, or patients who were participating in another trial using an investigational drug or investigational medical device within 28 days prior to giving consent.
(21) Female patients of childbearing potential who had a positive result on the pregnancy test at screening or baseline, as well as lactating patients.
(22) Patients who were judged to be unsuitable for participation in this clinical trial by the Principal Investigator or Sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Proportion of subjects who had CDAI reduction of at least 100 points from baseline (CR100 response rate)<br>CDAI
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>CR70 response rate, CDAI Remission rate, PRO2-Response rate, PRO2-Remission rate, SES-CD Response rate, SES-CD Remission rate, Corticosteroid-free response rate, Corticosteroid-free remission rate<br>CDAI, PRO2, SES-CD, volume of steroid, TEAEs, Laboratory