Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT02985593
Eligibility Criteria:
"Part1:
Inclusion Criteria:
1. Voluntary written informed consent to participate in the study;
2. Japanese or White men ≥20 and \<45 years at the time of informed consent;
Exclusion Criteria:
1. Current illness requiring treatment;
2. Current respiratory, gastric, renal, or liver disease;
Part2:
Inclusion Criteria:
1. Voluntary written informed consent to participate in the study;
2. Men or women ≥20 years of age at the time of informed consent;
3. Ulcerative colitis diagnosed ≥6 months prior to informed consent;
4. Moderate or more severe ulcerative colitis;
Exclusion Criteria:
1. Definitive diagnosis of bacillary dysentery, amebic colitis, Salmonella enteritis, Campylobacter enteritis, colonic tuberculosis, Chlamydia enteritis, Crohn's disease, radiation colitis, drug-induced colitis, angiolymphoid hyperplasia, ischemic colitis, or intestinal Behcet's disease;
2. Any of the following clinically significant concurrent illnesses:
* Type 1 diabetes
* Poorly controlled type 2 diabetes (HbA1c \>8.5%)
* Congestive heart failure (class II to IV of the New York Heart Association classification)
* Myocardial infarction within 1 year
* Unstable angina pectoris within 1 year
* Poorly controlled hypertension (systolic pressure \>150 mmHg or diastolic pressure \>90 mmHg at screening)
* Severe chronic lung diseases requiring oxygen therapy
* Multiple sclerosis or other demyelinating diseases
* Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma);
3. Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 2);
4. Suspected or confirmed symptomatic stenosis of the colon, abdominal abscess, or ischemic colitis based on clinical or radiographic data within 1 year prior to enrollment; suspected or confirmed toxic megacolon or history of toxic megacolon; history of any colonic resection, subtotal or total colectomy, ileostomy, or colostomy; or any previous surgery for ulcerative colitis or an anticipated requirement for surgery for ulcerative colitis;
5. Known colonic dysplasia, adenomas, or polyposis (excluding benign polyposis);
6. Any planned surgical treatment during the study;
7. Clostridium difficile infection within 8 weeks prior to enrollment;
8. Any active infection, including Grade ≥2 localized diseases per Common Terminology Criteria for Adverse Events, version 4.0, Japan Clinical Oncology Group edition (CTCAE v4.0-JCOG), within 4 weeks prior to enrollment;
9. Treatment with 5-aminosalicylic acid (5-ASA) enema, 5-ASA suppository, steroid enema, or steroid suppository within 2 weeks prior to enrollment;
10. Treatment with adalimumab within 2 weeks prior to enrollment or treatment with infliximab within 8 weeks prior to enrollment;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02985593
Study Brief:
Protocol Section:
NCT02985593