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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited Identifier:
First received: January 27, 2013
Last updated: June 10, 2013
Last verified: June 2013

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
Drug: KHK4827
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Company, Limited:

Primary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pustular symptom score (only in subjects with pustular psoriasis) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Incidence and types of adverse events and adverse reactions [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory values and vital signs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Profiles of pharmacokinetics [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Concentration of KHK4827 in serum

  • Development of anti-KHK4827 antibody [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT01782937

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 Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited Identifier: NCT01782937     History of Changes
Other Study ID Numbers: 4827-004
Study First Received: January 27, 2013
Last Updated: June 10, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases processed this record on April 15, 2014