Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.
Interventions
DRUGKHK4827
DRUGPlacebo
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject has had stable moderate to severe plaque psoriasis for at least 6 months. * 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. * Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.
Exclusion criteria
* Subject diagnosed with erythrodermic psoriasis, pustular 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 investigational product on psoriasis. * Subject has any active Common Terminology Criteria for Adverse Events (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 the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus , topical vitamin A, activated form D3 or activated form D3 analogue preparations, weak through strong topical steroids (excluding application on the scalp, axillae, and groin) * Subject has used the following therapies within 28 days of the first dose: any other systemic psoriasis therapy (eg, vitamin A, calcineurin inhibitors, methotrexates, steroids), UVA therapy (with or without psoralen), very strong or strongest topical steroid, tar therapy * Subject has used the following therapies within 3 months of the first dose: adalimumab, etanercept, infliximab, or live vaccines * Subject has used ustekinumab within 6 months of the first dose * Subject has previously used an anti-interleukin-17 biologic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| PASI 50, 90 and 100 at Week 12 | 12 weeks |
| Static physician's global assessment (sPGA) of clear or almost clear (0 or 1) at Week 12 | 12 Weeks |
| sPGA of clear (0) at Week 12 | 12 weeks |
| PASI 75 at Week 12 | 12 Weeks |
| American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12 | 12 weeks |
| Incidence and types of adverse events and adverse reactions | 12 weeks |
| Profiles of Pharmacokinetics | 12 weeks |
| Body surface area involvement (BSA) of lesion at Week 12 | 12 weeks |
Countries
Japan
Outcome results
None listed