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, PASI score >=12, sPGA score of >=3
Exclusion criteria
Exclusion criteria: -Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect participant safety within the study or of interfering with the interpretation of data. -Breastfeeding or nursing women. -Have had serious, opportunistic, or chronic/recurring infection within 3 months prior to screening. -Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either 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 12 weeks prior to baseline. -Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy sPGA,PASI 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics PASI etc., PK parameters | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed