A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Guselkumab; Placebo
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1027.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: biologic; biologic therapy

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.
    

Eligibility 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).