A Phase 2 Clinical Study of KHK4827
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|ClinicalTrials.gov Identifier: NCT01748539|
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : September 5, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Plaque Psoriasis||Drug: KHK4827 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
|Experimental: KHK4827 70mg SC||
|Experimental: KHK4827 140mg SC||
|Experimental: KHK4827 210mg SC||
|Placebo Comparator: Placebo SC||
- Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 [ Time Frame: 12 weeks ]
- PASI 75 at Week 12 [ Time Frame: 12 Weeks ]
- PASI 50, 90 and 100 at Week 12 [ Time Frame: 12 weeks ]
- Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 [ Time Frame: 12 Weeks ]
- sPGA of "clear (0)" at Week 12 [ Time Frame: 12 weeks ]
- Body surface area involvement (BSA) of lesion at Week 12 [ Time Frame: 12 weeks ]
- American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12 [ Time Frame: 12 weeks ]
- Incidence and types of adverse events and adverse reactions [ Time Frame: 12 weeks ]
- Profiles of Pharmacokinetics [ Time Frame: 12 weeks ]
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|Ages Eligible for Study:||20 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748539
|For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin|
|Chiyoda-ku, Tokyo, Japan|
|Responsible Party:||Kyowa Kirin Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||December 12, 2012 Key Record Dates|
|Last Update Posted:||September 5, 2013|
|Last Verified:||September 2013|
Skin Diseases, Papulosquamous