Psoriasis
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has signed voluntarily the written informed consent form to participate in this study. - Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma. - Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: - Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion < 80% at baseline. - Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis. - Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on psoriasis. - Subject has any active CTCAE grade 2 or higher infection - Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol. - Subject has used UVB therapy within 14 days of the first dose or UVA (with or without psoralen) within 28 days of the first dose. - Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively. - Subject has stopped ustekinumab or other anti-IL-23 biologics therapy due to lack of efficacy - Subject has used live vaccine within 3 months of the first dose - Subject has previously used an anti-IL17 biologic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Clinical Global Impression (CGI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy/Safety - Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) - American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) - Pustular symptom score (only in subjects with pustular psoriasis) - Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" (only in subjects with psoriatic erythroderma) - sPGA of "clear (0)" (only in subjects with psoriatic erythroderma) - Body surface area involvement (BSA) of lesion (only in subjects with psoriatic erythroderma) - Incidence and types of adverse events and adverse reactions - Changes in laboratory values and vital signs - Presence of anti-KHK4827 antibody - Development of pharmacokinetics | — |
Outcome results
None listed