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Completed

NCT Number: NCT04183881

A Phase 4 Clinical Study of Brodalumab

This study [4827-005 (post market)] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) 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). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.

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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 4

Primary location

The Jikei University Scoole of Medicine

Tokyo, 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 study 4827-005 (phase 3)

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

Brodalumab 210mg SC

Drug

210 mg, subcutaneous dosing, every 2 weeks

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

    This score indicate the severity of generalized pustular psoriasis (GPP). The severity of GPP (0:none-3:severe) is classified as mild(1), moderateor(2) severe(3) based on a total score after rating skin symptoms (erythema, pustules and edema) and systemic inflammation accom-panied by certain laboratory findings (fever, white blood cellcount, and serum CRP and albumin levels).

  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 Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2019
Registry last updated
Dec 9, 2019

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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