A Phase 3 Clinical Study of KHK 4827

Psoriatic Arthritis Clinical Trial

Official title:

An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052609
• Other study ID #: 4827-005
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: July 4, 2016

Study information

• Verified date: November 2019
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: July 4, 2016
• Est. primary completion date: January 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Dermatitis, Exfoliative
• Psoriasis
• Psoriasis Vulgaris
• Psoriatic Arthritis
• Psoriatic Erythroderma
• Pustular; Psoriasis, Palmaris Et Plantaris

Intervention

Drug:
• KHK4827 140mg SC
Experimental1:KHK4827 140mg subcutaneous injection
• KHK4827 210mg SC
Experimental2:KHK4827 210mg subcutaneous injection

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact Kyowa Kirin	Chiyoda-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and types of adverse events and adverse reactions		28 weeks
Primary	Anti-KHK4827 antibody		28 weeks
Secondary	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
Secondary	Percent improvement in PASI		28 Weeks
Secondary	PASI 50, 75, 90, and 100		28 Weeks
Secondary	Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"		28 Weeks
Secondary	sPGA of "0 (clear)		28 weeks
Secondary	Change in body surface area involvement (BSA) of lesion		28 weeks
Secondary	Clinical Global Impression (CGI)		28 weeks
Secondary	American College of Rheumatology (ACR) 20		28 weeks
Secondary	Pustular symptom score		28 weeks
Secondary	Serum KHK4827 concentration		28 weeks