Study identifier:D5172C00001
ClinicalTrials.gov identifier:NCT01959165
EudraCT identifier:N/A
CTIS identifier:N/A
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ulcerative colitis
Phase 2
No
MEDI7183 low dose, MEDI7183 medium dose, MEDI7183 high dose, Matching Placebo
All
44
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2019 by AstraZeneca
AstraZeneca
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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
Location
Location
Sapporo-shi, Japan, 065-0033
Location
Kyoto-shi, Japan, 606-8507
Location
Nishinomiya-shi, Japan, 663-8501
Location
Sakura-shi, Japan, 285-8741
Location
Osaka-shi, Japan, 545-8586
Location
Chikushino-shi, Japan, 818-8502
Location
Minato-ku, Japan, 108-8642
Location
Sayama-shi, Japan, 350-1305
Arms | Assigned Interventions |
---|---|
Experimental: MEDI7183 dose 1 Double blinded | Drug: MEDI7183 low dose MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 |
Experimental: MEDI7183 dose 2 Double blinded | Drug: MEDI7183 medium dose MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 |
Experimental: MEDI7183 dose 3 Double blinded | Drug: MEDI7183 high dose MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8 |
Placebo Comparator: Placebo Double blinded | Drug: Matching Placebo Placebo will be administered by SC on Day 1, Week 2,4, and 8 |
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