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

• Status: Completed
• Trial end date: 2018-02-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Ixekizumab

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.