A Phase 3 Clinical Study of KHK 4827
An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Sponsor study identifier
interventional
155
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 28, 2015
Actual (reported)Study Completion
July 4, 2016
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 4, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2014
Actual (reported)February 2014
Date type not reportedThis date has not been verified as actual or estimated.
February 3, 2014
Actual (reported)January 28, 2015
Actual (reported)July 4, 2016
Actual (reported)Incidence and types of adverse events and adverse reactions
28 weeks
Anti-KHK4827 antibody
28 weeks
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
28 weeks
Percent improvement in PASI
28 Weeks
PASI 50, 75, 90, and 100
28 Weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
28 Weeks
sPGA of "0 (clear)
28 weeks
For additional information regarding investigative sites for this trial, contact Kyowa Kirin
Chiyoda-ku, Tokyo, 100-8185, Japan
155 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2014
First Posted
February 3, 2014
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
A Study of Golimumab in Participants With Active Psoriatic Arthritis
Contact the study team to confirm eligibility.
Primary Completion
January 28, 2015
Actual (reported)Study Completion
July 4, 2016
Actual (reported)Last Updated
August 25, 2023
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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