Last updated on November 2019

A 24-week multicenter, randomized, double-blind, parallel-group study comparing the efficacy and safety of ixekizumab to guselkumab in patients with moderate-to-severe plaque psoriasis.


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Psoriasis | Skin Infections/Disorders | Psoriasis and Psoriatic Disorders | Moderate to Severe Plaque Psoriasis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

 

Inclusion Criteria:

  • Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
  • Have had a failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate [MTX], or phototherapy) and 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.

 

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  • Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating other IL-17 or IL-23p19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).

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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