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  • Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating other IL-17 or IL-23p19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

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 		Ixekizumab administered subcutaneously (SC).
  • Drug: Ixekizumab
    Administered SC
    Other names:
    • LY2439821
Experimental
Guselkumab 		Guselkumab administered SC. Placebo administered SC to maintain the blind.
  • Drug: Guselkumab
    Administered SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
2055029960

More Details

NCT ID
NCT03573323
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinicaltrials.gov@lilly.com

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.