psoriasis
Conditions
Interventions
investigational material(s)
Generic name etc : LY2439821
INN of investigational material : Ixekizumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This study will enroll male or female patients aged 18 years or older who have chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months who are candidates for phototherapy and/or systemic therapy, and who have more than 10% BSA involvement, an sPGA score of more than 3, and a PASI score more than 12 at screening and baseline.
Exclusion criteria
Exclusion criteria: -Pustular, erythrodermic, and/or guttate forms of psoriasis -History of drug-induced psoriasis -Clinically significant flare of psoriasis during the 12 weeks prior to randomization -Concurrent or recent use of any biologic agent -Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization -Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study -Have participated in any study with interleukin (IL)-17 antagonists, including LY2439821 -Serious disorder or illness other than plaque psoriasis -Serious infection within the last 3 months -B19Breastfeeding or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - | — |
Countries
Europe, Japan, North America, Oceania
Outcome results
None listed