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

Eli Lilly and Company1,027 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,027

Conditions

Plaque Psoriasis

Interventions

IxekizumabDRUG

Administered SC

GuselkumabDRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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

Locations (124)

Outcomes

Primary Outcomes

Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

Time frame: Week 12

Secondary Outcomes

Percentage of Participants Achieving PASI 75

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline.

Time frame: Week 2

Percentage of Participants Achieving PASI 90

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

Time frame: Week 4

Percentage of Participants Achieving PASI 100

Data from ClinicalTrials.gov

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