A Phase 3 Clinical Study of KHK 4827

Phase 3CompletedNCT02052609

Kyowa Kirin Co., Ltd.155 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Psoriasis Vulgaris Psoriatic Arthritis Pustular; Psoriasis, Palmaris Et Plantaris Psoriatic Erythroderma

Interventions

KHK4827 140mg SCDRUG

Experimental1:KHK4827 140mg subcutaneous injection

KHK4827 210mg SCDRUG

Experimental2:KHK4827 210mg subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Chiyoda-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Incidence and types of adverse events and adverse reactions

Time frame: 28 weeks

Anti-KHK4827 antibody

Time frame: 28 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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