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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01959165 |
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Date of registration:
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08/10/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
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Scientific title:
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Date of first enrolment:
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November 21, 2013 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01959165 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Toshifumi Hibi, Director and Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University |
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Name:
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Ki Rito, Study Physician |
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Address:
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Telephone:
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Email:
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Affiliation:
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AztraZeneca, Tokyo, Japan |
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Key inclusion & exclusion criteria
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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-a 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: MEDI7183 low dose
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Drug: MEDI7183 medium dose
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Drug: MEDI7183 high dose
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Drug: Matching Placebo
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Primary Outcome(s)
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Number of Participants With Remission at Week 8
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Number of Participants With Mucosal Healing at Week 8
[Time Frame: 8 weeks]
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Number of Participants With Response at Week 12
[Time Frame: 12 weeks]
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Number of Participants With Response at Week 8
[Time Frame: 8 weeks]
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Secondary ID(s)
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D5172C00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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