Overview

A Phase 4 Clinical Study of Brodalumab

Status:
Completed

Trial end date:
2017-07-24

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Kyowa Kirin Co., Ltd.

Treatments:

Antibodies, Monoclonal
Brodalumab

Criteria

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