NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Ulcerative Colitis
Date of first enrollment	16/01/2014
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : MEDI7183 low dose,medium dose,high dose INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : MEDI7183 low dose:MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 MEDI7183 medium dose:MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 MEDI7183 high dose: MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8 control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo will be administered by SC on Day 1, Week 2,4, and 8

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 65age old
Gender	Both
Include criteria	- Provision of informed consent prior to any study specific procedures - Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a histopathology report - Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with rectosigmoidoscopy score 2 during screening period or more - Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-alpha agents. etc.
Exclude criteria	- Disease limited to the rectum - Toxic megacolon - Crohn's Disease - History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC - Planned bowel surgery within 12 weeks from Visit 2 - Stool positive for C. difficile toxin at screening - Primary Sclerosing Cholangitis - History of gastrointestinal surgery within 8 weeks of Visit 2 - Any uncontrolled or clinically significant systemic disease - Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion - Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc