A Phase 4 Clinical Study of Brodalumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-04

Study Completion Date

2017-07-24

Brief Summary

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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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Detailed Description

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Conditions

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Psoriasis Vulgaris Psoriatic Arthritis Pustular; Psoriasis, Palmaris Et Plantaris Psoriatic Erythroderma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brodalumab 210mg SC

Brodalumab 210mg subcutaneous injection

Group Type EXPERIMENTAL

Brodalumab 210mg SC

Intervention Type DRUG

210 mg, subcutaneous dosing, every 2 weeks

Interventions

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Brodalumab 210mg SC

210 mg, subcutaneous dosing, every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No