A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of 3 dose of MEDI7183 Subcutaneously Administered in Japanese Subjects with Moderate to Severe Ulcerative Colitis
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-jRCT2080222367
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method