A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
The primary purpose for this study is to help answer the following research questions
The study is a Phase 2 study with 3 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design, Part B is an optional, open label extension design and Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks). Approximately 125 participants will be randomized to 1 of 4 ixekizumab groups or to placebo (approximately 25 participants per group) in Part A. Participants will be evaluated for treatment efficacy and the primary endpoint will be evaluated at week 12. Between week 20 and week 32, participants with a less than 75% improvement in their Psoriasis Area and Severity Index (PASI) score compared to baseline will be eligible to begin Part B. Participants in Part B will receive subcutaneous (SC) injections of ixekizumab 120 milligrams (mg) every 4 weeks through week 236. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Participants in Part C may receive SC injections of ixekizumab 80 mg every 4 weeks for up to an additional 104 weeks through approximately week 340. Participants who complete Part A, Part B, and Part C will have a total study participation of approximately 344 weeks.
Inclusion Criteria Common to Both Part A:
Inclusion Criterion Specific to Part B
Inclusion Criterion Specific to Part C
Exclusion Criteria Common to Part A, B and C:
Exclusion Criteria Specific to B:
Exclusion Criteria Specific to C:
Bakersfield, California 93309, United States
New Haven, Connecticut 06511, United States
Washington D.C., District of Columbia 20037, United States
Miami, Florida 33175, United States
Miramar, Florida 33027, United States
Newnan, Georgia 30263, United States
Arlington Heights, Illinois 60005, United States
Skokie, Illinois, United States
West Dundee, Illinois 60118, United States
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Boston, Massachusetts 02114, United States
Ann Arbor, Michigan 48109, United States
St Louis, Missouri 63117, United States
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Aarhus, 8000, Denmark
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