Inflammatory bowel disease
Conditions
Interventions
Study drug will be administered by an endoscope to active mucosal lesions. The patients will be received 250 nM of STNM01 on Day 1, Day 15 and Day 29. They will return to the study site for follow-up
Sponsors
Sameshima Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The subject is a patient with Ulcerative colitis or Crohns disease with active mucosal lesion. 2) The subject has been treated for more than 3 months before the screening tests by conventional drug generally used to treat Ulcerative colitis of Crohns disease. In the opinion of his primary doctor, the subject has experienced an insufficient response or resistance to the current conventional treatment. The subjects insufficient response or resistance to the current treatment is also confirmed by the principal investigator of this study, based on the screening tests including endoscopic examination, clinical examination and laboratory tests. The subject experiencing an insufficient response or resistance can be assessed at the principal investigators discretion; however, use of more than one prescribed medication and insufficient therapeutic effect by the medication at present should be documented in the subjects medical record. 3) The subject has little difficulty with the introduction of an endoscope, e.g., he has little stenosis or, if any, the diameter of the narrowed lesion is 14 mm or more. 4) The subject signs and dates a written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) The subject has or has a history of serious cardiac, hematological or pulmonary disease, and is unsuitable. 2) The subject has a history of complete colon resection surgery. 3) The subject has a complication of Ulcerative colitis such as severe bleeding or intestinal adhesions to other organs, and is unsuitable. 4) The subject has a hepatic impairment or renal disorder, and is unsuitable. 5) The subject has or has a history of malignant tumor within the past 5 years. 6) The subject has or has a history of abdominal phthisis. 7) The subject has a complication of serious infection that requires hospitalization. 8) The subject should be excluded if he is currently treated with an anti-TNF- antibody and has one or more of the following conditions: (1) The subject has a complication or history of tuberculosis. (2) The subject has any of the following conditions other than tuberculosis. 9) The subject has a history of clinically serious allergic symptom. 10) The person has alcohol or drug dependency. 11) The subject is currently participating or plans to participate in another clinical study during the course of this study. 12) The subject has any psychiatric or neurological disorder, and is unsuitable. 13) For females, pregnancy or lactation. 14) Not willing and able to use a reliable and acceptable contraceptive method (Pearl Index < 1). The subjects or their sexual partners, respectively, must use at least one of these reliable methods from 6 weeks before until 3 weeks after the administration of the study medication. 15) The subject is considered by the investigator, for any other reason, to be unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic response | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic remission Adverse effects and adverse drug reactions | — |
Countries
Japan
Contacts
Public ContactYukinori Sameshima
Sameshima Hospital internal medicine
Outcome results
None listed