臨床研究等提出・公開システム

Date of registration	Jan. 16, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222367

Scientific Title	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
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	RD-clinical-information-Japan@astrazeneca.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, Efficacy Study, Parallel Assignment, Double Blind
Study Design	Objective
Phase		2
Key inclusion & exclusion 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	- 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
	Minimum Age	18age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		Ulcerative Colitis
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
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor

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Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-142417
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	June. 28, 2018	Detail	Changes
5	June. 28, 2018	Detail	Changes
4	July. 14, 2015	Detail	Changes
3	July. 14, 2015	Detail	Changes
2	Jan. 16, 2014	Detail	Changes
1	Jan. 16, 2014	Detail

List of change history