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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK4827 70mg SC | Experimental |
| |
| KHK4827 140mg SC | Experimental |
| |
| KHK4827 210mg SC | Experimental |
| |
| Placebo SC | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK4827 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PASI 75 at Week 12 | 12 Weeks | |
| 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 |
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Inclusion 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 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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin | Chiyoda-ku | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26547109 | Derived | Nakagawa H, Niiro H, Ootaki K; Japanese brodalumab study group. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: Efficacy and safety results from a phase II randomized controlled study. J Dermatol Sci. 2016 Jan;81(1):44-52. doi: 10.1016/j.jdermsci.2015.10.009. Epub 2015 Oct 24. |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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| Drug |
|
| 12 Weeks |
| sPGA of "clear (0)" at Week 12 | 12 weeks |
| Body surface area involvement (BSA) of lesion 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 |