A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
Completed · Phase 3 · Has a placebo group
Conditions studied: Genital Psoriasis, Psoriasis
In brief
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.
Key facts
- Study ID
- NCT02718898
- Run by
- Eli Lilly and Company
- People needed
- 149
- Starts
- 2016-04-01
- Expected to finish
- 2018-02-21
- Last updated by the study team
- 2019-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
- 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. — Darlinghurst, 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. — Woolloongabba, 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. — Graz, Austria
- 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. — Vienna, Austria
- 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. — Vienna, Austria
- 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. — Brussels, Belgium
- 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. — Brussels, Belgium
- 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. — Ghent, Belgium
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. — London, Canada
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. — Markham, Canada
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