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An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782937
First Posted: February 4, 2013
Last Update Posted: February 16, 2015
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.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  Purpose
This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.

Condition Intervention Phase
Psoriasis Drug: KHK4827 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: 52 weeks ]
    CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened


Secondary Outcome Measures:
  • Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: 52 weeks ]
  • American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) [ Time Frame: 52 weeks ]
  • Pustular symptom score (only in subjects with pustular psoriasis) [ Time Frame: 52 weeks ]
  • Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma) [ Time Frame: 52 weeks ]
  • sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma) [ Time Frame: 52 weeks ]
  • Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma) [ Time Frame: 52 weeks ]
  • Incidence and types of adverse events and adverse reactions [ Time Frame: 52 weeks ]
  • Laboratory values and vital signs [ Time Frame: 52 weeks ]
  • Profiles of pharmacokinetics [ Time Frame: 52 weeks ]
    Concentration of KHK4827 in serum

  • Development of anti-KHK4827 antibody [ Time Frame: 52 weeks ]

Enrollment: 30
Study Start Date: February 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KHK4827 Drug: KHK4827
140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has signed voluntarily the written informed consent form to participate in this study.
  • Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma.
  • 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.

Exclusion Criteria:

  • Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion < 80% at baseline.
  • Subject diagnosed with guttate 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 KHK4827 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 Ultra Violet B (UVB) therapy within 14 days of the first dose or Ultra Violet A (UVA) (with or without psoralen) within 28 days of the first dose.
  • Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively.
  • Subject has stopped ustekinumab or other anti-Interleukin (IL)-23 biologics therapy due to lack of efficacy
  • Subject has used live vaccine within 3 months of the first dose
  • Subject has previously used an anti-IL-17 biologic therapy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01782937


Locations
Japan
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan, 100-8185
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01782937     History of Changes
Other Study ID Numbers: 4827-004
First Submitted: January 27, 2013
First Posted: February 4, 2013
Last Update Posted: February 16, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases