A Phase 3 Clinical Study of KHK 4827

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

PHASE3

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-07-04

Brief Summary

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This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) 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).

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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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KHK4827 140mg SC

Group Type EXPERIMENTAL

KHK4827 140mg SC

Intervention Type DRUG

Experimental1:KHK4827 140mg subcutaneous injection

KHK4827 210mg SC

Group Type EXPERIMENTAL

KHK4827 210mg SC

Intervention Type DRUG

Experimental2:KHK4827 210mg subcutaneous injection

Interventions

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KHK4827 140mg SC

Experimental1:KHK4827 140mg subcutaneous injection

Intervention Type DRUG

KHK4827 210mg SC

Experimental2:KHK4827 210mg subcutaneous injection

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 week 52 evaluation either in Study 003 or 004

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