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COMPLETEDPHASE3

An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis

A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

NCT01782937•Kyowa Kirin Co., Ltd.

Summary

This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has signed voluntarily the written informed consent form to participate in this study.
•Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma.
•Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.

Exclusion Criteria

•Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion \< 80% at baseline.
•Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis.
•Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of KHK4827 on psoriasis.
•Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
•Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
•Subject has used Ultra Violet B (UVB) therapy within 14 days of the first dose or Ultra Violet A (UVA) (with or without psoralen) within 28 days of the first dose.
•Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively.
•Subject has stopped ustekinumab or other anti-Interleukin (IL)-23 biologics therapy due to lack of efficacy
•Subject has used live vaccine within 3 months of the first dose
•Subject has previously used an anti-IL-17 biologic therapy

Locations (1)

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

Chiyoda-ku, Tokyo, Japan

Key Dates

Start Date

February 1, 2013

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2014

Last Updated

February 16, 2015

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

KHK4827

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 16, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments