CompletedPhase 4

A Phase 4 Clinical Study of Brodalumab

Japan138 participantsStarted 2016-07-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Incidence and types of adverse events and adverse reactions

Timeframe: 28 weeks

Anti-KHK4827 antibody

Timeframe: 28 weeks

Trial details

NCT IDNCT04183881

SponsorKyowa Kirin Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-01-10

View on ClinicalTrials.gov More Psoriasis Vulgaris trials