A Phase 3 Clinical Study of KHK4827

NCT ID: NCT01782924

Last Updated: 2015-02-16

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

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-02-28

Brief Summary

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This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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KHK4827 140mg SC

Group Type EXPERIMENTAL

KHK4827

Intervention Type DRUG

KHK4827 210mg SC

Group Type EXPERIMENTAL

KHK4827

Intervention Type DRUG

Interventions

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KHK4827

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 12 evaluation of Study 4827-002

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/subinvestigators
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 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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For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Chiyoda-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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4827-003

Identifier Type: -

Identifier Source: org_study_id

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