A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

• Status: Completed
• Trial end date: 2020-01-08
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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 Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (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.

Exclusion Criteria:

• 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• Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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).