Back to resultsMEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MEDI7183 low dose
MEDI7183 medium dose
MEDI7183 high dose
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Japanese, subcutaneously
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MEDI7183 dose 1
MEDI7183 dose 2
MEDI7183 dose 3
Placebo
Arm Description
Double blinded
Double blinded
Double blinded
Double blinded
Outcomes
Primary Outcome Measures
Number of Participants With Remission at Week 8
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
Number of Participants With Response at Week 8
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
Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.
Number of Participants With Response at Week 12
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01959165
Brief Title
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 21, 2013 (Actual)
Primary Completion Date
August 11, 2015 (Actual)
Study Completion Date
April 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Japanese, subcutaneously
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI7183 dose 1
Arm Type
Experimental
Arm Description
Double blinded
Arm Title
MEDI7183 dose 2
Arm Type
Experimental
Arm Description
Double blinded
Arm Title
MEDI7183 dose 3
Arm Type
Experimental
Arm Description
Double blinded
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Double blinded
Intervention Type
Drug
Intervention Name(s)
MEDI7183 low dose
Intervention Description
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
Intervention Type
Drug
Intervention Name(s)
MEDI7183 medium dose
Intervention Description
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
Intervention Type
Drug
Intervention Name(s)
MEDI7183 high dose
Intervention Description
MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Placebo will be administered by SC on Day 1, Week 2,4, and 8
Primary Outcome Measure Information:
Title
Number of Participants With Remission at Week 8
Description
Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Response at Week 8
Description
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.
Time Frame
8 weeks
Title
Number of Participants With Mucosal Healing at Week 8
Description
Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.
Time Frame
8 weeks
Title
Number of Participants With Response at Week 12
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshifumi Hibi, Director and Professor
Organizational Affiliation
Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ki Rito, Study Physician
Organizational Affiliation
AztraZeneca, Tokyo, Japan
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Chikushino-shi
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Research Site
City
Fujiidera-shi
ZIP/Postal Code
583-0027
Country
Japan
Facility Name
Research Site
City
Fukuyama-shi
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Research Site
City
Hamamatsu-shi
ZIP/Postal Code
432-8061
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Research Site
City
Kamakura-shi
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Research Site
City
Minato-ku
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Research Site
City
Morioka-shi
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
950-1104
Country
Japan
Facility Name
Research Site
City
Nishinomiya-shi
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Research Site
City
Oita-shi
ZIP/Postal Code
870-0033
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Research Site
City
Sakura-shi
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Research Site
City
Sayama-shi
ZIP/Postal Code
350-1305
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
ZIP/Postal Code
141-0022
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Research Site
City
Yokkaichi-shi
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
12. IPD Sharing Statement
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MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
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