Psoriasis
Conditions
Interventions
investigational material(s)
Generic name etc : KHK4827
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigatio
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 of 10% or more and PASI of 12 or more at screening and at baseline.
Exclusion criteria
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 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 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-IL17 biologic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy/Safety Efficacy; -PASI 75 at Week 12 -PASI 50, 90 and 100 at Week 12 -Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 - sPGA of "clear (0)"at Week 12 -Body surface area involvement (BSA) of lesion at Week 12 -ACR20 (only in subjects with psoriasis arthritis) Safety; -Incidence and types of adverse events and adverse reactions | — |
Outcome results
None listed