A Phase 3 Clinical Study of KHK4827

February 12, 2015 updated by: Kyowa Kirin Co., Ltd.

An Extension Study in Subjects With Plaque Psoriasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 100-8185
        • For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KHK4827 140mg SC
Drug: KHK4827
Experimental: KHK4827 210mg SC
Drug: KHK4827

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and types of adverse events and adverse reactions
Time Frame: 52 weeks
52 weeks
Laboratory values and vital signs
Time Frame: 52 weeks
52 weeks
Development of anti-KHK4827 antibody
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
Time Frame: 52 weeks
52 weeks
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
Time Frame: 52 weeks
52 weeks
Profiles of pharmacokinetics
Time Frame: 52 weeks
Concentration of KHK4827 in serum
52 weeks
A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response
Time Frame: 52 weeks
52 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"
Time Frame: 52 weeks
52 weeks
sPGA of "clear (0)"
Time Frame: 52 weeks
52 weeks
Body surface area involvement (BSA) of lesion
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 27, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4827-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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