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

Lilly

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Ustekinumab; Drug: Placebo; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02561806

16012

I1F-MC-RHBS (Other Identifier)

2015-000892-28 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic plaque psoriasis for at least 6 months before baseline
• Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
• Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
• Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment

Exclusion criteria

• Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
• History of drug-induced psoriasis
• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
• Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
• Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent <5 half-lives prior to baseline
• Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab 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• Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
• Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
• Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
• Have a known allergy or hypersensitivity to latex
• Have had any major surgery within 8 weeks of baseline or will require such during the study
• Have active or history of malignant disease within 5 years prior to baseline
• Significant uncontrolled disorder
• Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
• Are women who are lactating or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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302 participants in 2 patient groups

Ustekinumab

Active Comparator group

Description:

45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.

Treatment:

Drug: Placebo

Drug: Ustekinumab

Ixekizumab

Experimental group

Description:

160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.

Treatment:

Drug: Placebo

Drug: Ixekizumab