MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: MEDI7183 high dose; Drug: MEDI7183 low dose; Drug: Matching Placebo; Drug: MEDI7183 medium dose

• Registration Number: NCT01959165
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Study Start: 2013-11-21
• Primary Completion: 2015-08-11
• Study Completion: 2018-04-10
• Results First Submitted: 2018-06-04
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-16
• Last Update Submitted: 2019-04-16
• Results First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDI7183 dose 3	MEDI7183 high dose	Double blinded
MEDI7183 dose 1	MEDI7183 low dose	Double blinded
Placebo	Matching Placebo	Double blinded
MEDI7183 dose 2	MEDI7183 medium dose	Double blinded

Primary Outcome Measures

Name	Time	Method
Number of Participants With Remission at Week 8	8 weeks	Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Response at Week 8	8 weeks	Response at Week 8 was assessed by total Mayo score. Response was defined as decrease 3 points or more and 30 percents in total Mayo score compared to baseline, and with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or with an absolute subscore for rectal bleeding of 0 or 1.
Number of Participants With Mucosal Healing at Week 8	8 weeks	Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.
Number of Participants With Response at Week 12	12 weeks	Response at Week 12 was assessed by Partial Mayo Score. Response was defined as reduction by 2 or more points and 25% in Partial Mayo Score compared to baseline.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yokohama-shi, Japan