A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.
- Plaque Psoriasis
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
- Are a candidate for phototherapy and/or systemic therapy.
- Have both an sPGA score of ≥3 and a PASI score ≥12 at screening and at baseline.
- Have ≥10% body surface area (BSA) involvement at screening and baseline.
- If a male, agree to use a reliable method of birth control during the study.
- If female, agree to use highly effective method of contraception.
- Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
- Have a history of drug-induced psoriasis.
- Had a clinically significant flare of psoriasis during the 12 weeks before baseline.
- Use of tanning booths for at least 4 weeks before baseline.
- Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept <28 days; infliximab, adalimumab, certolizumab pegol, or alefacept <60 days; golimumab <90 days; rituximab <12 months; secukinumab <5 months; or any other biologic agent (e.g., ustekinumab) <5 half lives.
- Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.
- Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating other IL-17 or IL-23p19 antagonists, or have received treatment with ixekizumab.
- Have previously failed to respond to an IL-17 antagonist, per investigator assessment.
- Have had a live vaccination within 12 weeks of baseline.
- Have a known allergy or hypersensitivity to any biologic therapy.
- Have had any major surgery within 8 weeks of baseline.
- Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.
- Are women who are pregnant, or who are lactating (breast-feeding).
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
|Ixekizumab administered subcutaneously (SC).||
|Guselkumab administered SC. Placebo administered SC to maintain the blind.||
- Eli Lilly and Company