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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01782937
First received: January 27, 2013
Last updated: May 15, 2014
Last verified: May 2014
  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: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01782937     History of Changes
Other Study ID Numbers: 4827-004
Study First Received: January 27, 2013
Last Updated: May 15, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 23, 2014