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

Lilly

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: Ixekizumab; Drug: Guselkumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03573323

I1F-MC-RHCR (Other Identifier)

17119

Details and patient eligibility

About

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

Enrollment: 1,027 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,027 participants in 2 patient groups

Ixekizumab

Experimental group

Description:

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.

Treatment:

Drug: Ixekizumab

Guselkumab

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Guselkumab