Psoriasis Clinical Trial
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
Eligibility Criteria
Inclusion Criteria:
Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline.
Have moderate-to-severe psoriasis in the genital area at screening and baseline.
Have plaque psoriasis in a nongenital area at screening and baseline.
Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area.
Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug.
Exclusion Criteria:
Pustular, erythrodermic, and/or guttate forms of psoriasis.
History of drug-induced psoriasis.
Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments).
Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action.
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study.
Are currently enrolled in any other clinical trial involving an investigational product.
Serious disorder or illness other than plaque psoriasis.
Active or history of malignant disease within 5 years prior to baseline.
Serious infection within the last 3 months.
Have received a live vaccine within 3 months of baseline or plan to do so during the study.
Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.
Pregnant or breastfeeding (lactating) women.
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There are 33 Locations for this study
Santa Ana California, 92701, United States
Santa Monica California, 90404, United States
Tampa Florida, 33609, United States
Sandy Springs Georgia, 30328, United States
Indianapolis Indiana, 46256, United States
South Bend Indiana, 46617, United States
Boston Massachusetts, 02111, United States
Portland Oregon, 97223, United States
Johnston Rhode Island, 02919, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Pflugerville Texas, 78660, United States
Salt Lake City Utah, 84132, United States
Adelaide , 5073, Australia
Carlton , 3053, Australia
Darlinghurst , 2010, Australia
Woolloongabba , 4102, Australia
Graz , 8036, Austria
Wien , 1090, Austria
Wien , 1130, Austria
Brussels , 1090, Belgium
Brussels , 1200, Belgium
Gent , 9000, Belgium
London , N6A 3, Canada
Markham , L3P1X, Canada
Montreal , H2K4L, Canada
Quebec , G1V 4, Canada
Surrey , V3V 0, Canada
Bergen op Zoom , 4624 , Netherlands
Breda , 4818 , Netherlands
San Juan , 00909, Puerto Rico
Bursa , 16059, Turkey
Gaziantep , 27310, Turkey
Istanbul , 34093, Turkey
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