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A Phase 4 Clinical Study of Brodalumab

NCT ID: NCT04183881

Last Updated: 2019-12-09

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.

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

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Jikei University Scoole of Medicine

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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4827-005 (post market)

Identifier Type: -

Identifier Source: org_study_id