A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

• Status: Completed
• Trial end date: 2020-07-22
• Target enrollment: 0
• Participant gender: All

Summary

The reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Present with GPP or EP based on an investigator-confirmed diagnosis and meet the associated criteria

• GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare (MHLW) at screening and baseline regardless of IL-36 mutation status.

• EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at screening and baseline.

• Candidates for phototherapy and/or systemic therapy

• Men must agree to use a reliable method of birth control during the study

• Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

• History of drug-induced psoriasis

• Concurrent or recent use of any biologic agent

• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study

• Have previously received ixekizumab

• Serious disorder or illness other than psoriasis

• Serious infection within the last 12 weeks

• Breastfeeding or nursing (lactating) women