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Completed

NCT Number: NCT01782937

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Chiyoda-ku, Tokyo, 100-8185, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KHK4827

Drug

140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)

Primary outcomes

  1. 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 outcomes

  1. Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)

    Time frame: 52 weeks

  2. American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)

    Time frame: 52 weeks

  3. Pustular symptom score (only in subjects with pustular psoriasis)

    Time frame: 52 weeks

  4. 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

  5. sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)

    Time frame: 52 weeks

  6. Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)

    Time frame: 52 weeks

  7. Incidence and types of adverse events and adverse reactions

    Time frame: 52 weeks

  8. Laboratory values and vital signs

    Time frame: 52 weeks

  9. Profiles of pharmacokinetics

    Time frame: 52 weeks

    Concentration of KHK4827 in serum

  10. Development of anti-KHK4827 antibody

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2013
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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