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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02052609

Enrollment

155

Registered

2014-02-03

Start date

2014-02-28

Completion date

2016-07-04

Last updated

2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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).

Interventions

DRUGKHK4827 140mg SC

Experimental1:KHK4827 140mg subcutaneous injection

DRUGKHK4827 210mg SC

Experimental2:KHK4827 210mg subcutaneous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Change in body surface area involvement (BSA) of lesion	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
American College of Rheumatology (ACR) 20	28 weeks
Pustular symptom score	28 weeks
Serum KHK4827 concentration	28 weeks
Clinical Global Impression (CGI)	28 weeks
Percent improvement in PASI	28 Weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026