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

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Ixekizumab; Ustekinumab

Criteria

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• Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23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