A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
NCT ID: NCT02718898
Last Updated: 2019-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
149 participants
INTERVENTIONAL
2016-04-30
2018-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ixekizumab
Blinded Treatment Period: 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab every 2 weeks (Q2W) SC from week 2 to week 10. At week 12, 80 mg ixekizumab and placebo given SC.
Open Label Period: 80 mg ixekizumab given SC every 4 weeks (Q4W) with an option for Q2W dosing starting at week 24, week 28 or week 40.
Ixekizumab
Administered SC
Placebo
Administered SC
Placebo
Blinded Treatment Period: Placebo given SC at baseline followed by placebo given SC Q2W from week 2 to week 10. At week 12, 160 mg ixekizumab given SC.
Open Label Period: 80 mg ixekizumab given SC Q4W with an option for Q2W dosing starting at week 24, week 28 or week 40.
Ixekizumab
Administered SC
Placebo
Administered SC
Interventions
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Ixekizumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Southern California Dermatology
Santa Ana, California, United States
Clinical Science Institute
Santa Monica, California, United States
Olympian Clinical Research
Tampa, Florida, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Oregon Medical Research Center
Portland, Oregon, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Pflugerville Dermatology Clinical Research Center
Pflugerville, Texas, United States
University of Utah
Salt Lake City, Utah, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Adelaide, , Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Carlton, , Australia
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Darlinghurst, , Australia
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Woolloongabba, , Australia
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Graz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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London, , Canada
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Markham, , Canada
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Montreal, , Canada
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Québec, , Canada
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Surrey, , Canada
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Bergen op Zoom, , Netherlands
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Breda, , Netherlands
GCM Medical Group PSC
San Juan, , Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bursa, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol: Protocol
Document Type: Study Protocol: Protocol (a)
Document Type: Study Protocol: Protocol (b)
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (IXORA-Q)
Other Identifiers
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I1F-MC-RHBQ
Identifier Type: OTHER
Identifier Source: secondary_id
2015-002628-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16010
Identifier Type: -
Identifier Source: org_study_id
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