Psoriasis
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Present with chronic plaque psoriasis for at least 6 months prior to baseline and meet the following criteria: plaque psoriasis involving 10% BSA or more, PASI score 12 or more, sPGA score of 3 or more.
Exclusion criteria
Exclusion criteria: -Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data. -Breastfeeding or nursing (lactating) women. -Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. -Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study. -Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results. -Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline. -Have received topical psoriasis treatment within 14 days prior to baseline. -Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 8 weeks prior to baseline. -Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy PASI 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics PASI etc., PK parameters | — |
Countries
Europe, Japan, North America
Outcome results
None listed