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A Phase 2 Clinical Study of KHK4827

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01748539
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Plaque Psoriasis Drug: KHK4827 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: KHK4827 70mg SC Drug: KHK4827
Experimental: KHK4827 140mg SC Drug: KHK4827
Experimental: KHK4827 210mg SC Drug: KHK4827
Placebo Comparator: Placebo SC Drug: Placebo

Primary Outcome Measures :
  1. Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. PASI 75 at Week 12 [ Time Frame: 12 Weeks ]
  2. PASI 50, 90 and 100 at Week 12 [ Time Frame: 12 weeks ]
  3. Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 [ Time Frame: 12 Weeks ]
  4. sPGA of "clear (0)" at Week 12 [ Time Frame: 12 weeks ]
  5. Body surface area involvement (BSA) of lesion at Week 12 [ Time Frame: 12 weeks ]
  6. American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12 [ Time Frame: 12 weeks ]
  7. Incidence and types of adverse events and adverse reactions [ Time Frame: 12 weeks ]
  8. Profiles of Pharmacokinetics [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01748539

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For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kyowa Kirin Co., Ltd. Identifier: NCT01748539    
Other Study ID Numbers: 4827-002
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents