MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

• Status: Completed
• Trial end date: 2018-04-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

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

• Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-α agents. etc.

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