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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.
 
ClinicalTrials.gov Identifier: NCT01748539
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 10, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date September 5, 2013
Study Start Date  ICMJE December 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Clinical Study of KHK4827
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Plaque Psoriasis
Intervention  ICMJE
  • Drug: KHK4827
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: KHK4827 70mg SC
    Intervention: Drug: KHK4827
  • Experimental: KHK4827 140mg SC
    Intervention: Drug: KHK4827
  • Experimental: KHK4827 210mg SC
    Intervention: Drug: KHK4827
  • Placebo Comparator: Placebo SC
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 10, 2012)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748539
Other Study ID Numbers  ICMJE 4827-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyowa Kirin Co., Ltd.
Study Sponsor  ICMJE Kyowa Kirin Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyowa Kirin Co., Ltd.
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP