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Completed

NCT Number: NCT01782924

A Phase 3 Clinical Study of KHK4827

This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

20 year–70 year

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 voluntarily signed the written informed consent form to participate in this study
  • Subject has completed the week 12 evaluation of Study 4827-002

Exclusion criteria

  • Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
  • Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators

Treatment and study plan

KHK4827

Drug

Primary outcomes

  1. Incidence and types of adverse events and adverse reactions

    Time frame: 52 weeks

  2. Laboratory values and vital signs

    Time frame: 52 weeks

  3. Development of anti-KHK4827 antibody

    Time frame: 52 weeks

Secondary outcomes

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

    Time frame: 52 weeks

  2. A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response

    Time frame: 52 weeks

  3. Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"

    Time frame: 52 weeks

  4. sPGA of "clear (0)"

    Time frame: 52 weeks

  5. Body surface area involvement (BSA) of lesion

    Time frame: 52 weeks

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

    Time frame: 52 weeks

  7. Profiles of pharmacokinetics

    Time frame: 52 weeks

    Concentration of KHK4827 in serum

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

An Extension Study in Subjects With Plaque Psoriasis

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
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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