Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 - Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ixekizumab
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
  • Drug: Ixekizumab
    Administered SC
    Other names:
    • LY2439821
Experimental
Guselkumab
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
  • Drug: Guselkumab
    Administered SC
  • Drug: Placebo
    Administered SC

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.