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Completed

NCT Number: NCT02052609

A Phase 3 Clinical Study of KHK 4827

This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).

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Key information

Conditions

Psoriasis Vulgaris Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Psoriatic Erythroderma Pustular; Psoriasis, Palmaris Et Plantaris Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

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 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 52 evaluation either in Study 003 or 004

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/sub investigators

Treatment and study plan

KHK4827 140mg SC

Drug

Experimental1:KHK4827 140mg subcutaneous injection

KHK4827 210mg SC

Drug

Experimental2:KHK4827 210mg subcutaneous injection

Primary outcomes

  1. Incidence and types of adverse events and adverse reactions

    Time frame: 28 weeks

  2. Anti-KHK4827 antibody

    Time frame: 28 weeks

Secondary outcomes

  1. Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.

    Time frame: 28 weeks

  2. Percent improvement in PASI

    Time frame: 28 Weeks

  3. PASI 50, 75, 90, and 100

    Time frame: 28 Weeks

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

    Time frame: 28 Weeks

  5. sPGA of "0 (clear)

    Time frame: 28 weeks

  6. Change in body surface area involvement (BSA) of lesion

    Time frame: 28 weeks

  7. Clinical Global Impression (CGI)

    Time frame: 28 weeks

  8. American College of Rheumatology (ACR) 20

    Time frame: 28 weeks

  9. Pustular symptom score

    Time frame: 28 weeks

  10. Serum KHK4827 concentration

    Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 3, 2014
Registry last updated
Aug 25, 2023

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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