A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:April 2016
End Date:February 21, 2018

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A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis

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.


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.
We found this trial at
14
sites
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: David Rosmarin
Phone: 617-636-7462
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Kristina Callis-Duffin
Phone: 801-581-6465
University of Utah Research is a major component in the life of the U benefiting...
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Adelaide,
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Dallas, Texas 75231
Principal Investigator: Jennifer Cather
Phone: 214-361-2008
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Dallas, Texas 75246
Principal Investigator: Alan Menter
Phone: 214-820-9114
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Indianapolis, Indiana 46256
Principal Investigator: Scott Fretzin
Phone: 317-621-7731
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Indianapolis, IN
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Johnston, Rhode Island 02919
Principal Investigator: Ellen Frankel
Phone: 401-454-3800
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Johnston, RI
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Pflugerville, Texas 78660
Principal Investigator: Edward Lain
Phone: 512-279-2545
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Portland, Oregon 97223
Principal Investigator: Andrew Blauvelt
Phone: 503-245-1525
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Sandy Springs, Georgia 30328
Principal Investigator: Jamie Weisman
Phone: 404-939-9220
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Santa Ana, California 92701
Principal Investigator: Jennifer Soung
Phone: 714-474-2173
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Santa Monica, California 90404
Principal Investigator: Paul Yamauchi
Phone: 310-828-8887
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
Principal Investigator: Holly Hake Harris
Phone: 574-204-6432
South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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Tampa, Florida 33609
Principal Investigator: Kelley Yokum
Phone: 813-849-5566
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