Ulcerative Colitis
Conditions
Interventions
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
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Outcome results
None listed