A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Trial end date: 2017-08-03
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

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

Details

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

Criteria

Inclusion Criteria:

• Present with chronic plaque psoriasis for at least 6 months prior to enrollment

• At least 10% BSA of psoriasis at screening and at enrollment

• sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment

• Candidates for phototherapy and/or systemic therapy

• Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Exclusion Criteria:

• Predominant pattern of pustular, erythrodermic, 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 prior to enrollment and during the study

• Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment

• Concurrent or recent use of any biologic agent

• Have participated in any study with ixekizumab

• Received a live vaccination within 12 weeks prior to enrollment

• Serious disorder or illness other than psoriasis

• Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis

• Major surgery within 8 weeks of baseline, or will require surgery during the study

• Breastfeeding or nursing (lactating) women