Overview

This trial is active, not recruiting.

Conditions psoriasis vulgaris,, psoriatic arthritis,, pustular psoriasis,, psoriatic erythroderma
Treatments khk4827 140mg sc, khk4827 210mg sc
Phase phase 3
Sponsor Kyowa Hakko Kirin Company, Limited
Start date February 2014
End date December 2016
Trial size 165 participants
Trial identifier NCT02052609, 4827-005

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
khk4827 140mg sc
Experimental1:KHK4827 140mg subcutaneous injection
(Experimental)
khk4827 210mg sc
Experimental2:KHK4827 210mg subcutaneous injection

Primary Outcomes

Measure
Incidence and types of adverse events and adverse reactions
time frame: 28 weeks
Anti-KHK4827 antibody
time frame: 28 weeks

Secondary Outcomes

Measure
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
time frame: 28 weeks
Percent improvement in PASI
time frame: 28 Weeks
PASI 50, 75, 90, and 100
time frame: 28 Weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
time frame: 28 Weeks
sPGA of "0 (clear)
time frame: 28 weeks
Change in body surface area involvement (BSA) of lesion
time frame: 28 weeks
Clinical Global Impression (CGI)
time frame: 28 weeks
American College of Rheumatology (ACR) 20
time frame: 28 weeks
Pustular symptom score
time frame: 28 weeks
Serum KHK4827 concentration
time frame: 28 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Kyowa Hakko Kirin Company, Limited.