Overview

This trial is active, not recruiting.

Condition psoriasis
Treatment khk4827
Phase phase 3
Sponsor Kyowa Hakko Kirin Company, Limited
Start date February 2013
End date December 2015
Trial identifier NCT01782937, 4827-004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
khk4827
140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)

Primary Outcomes

Measure
Clinical Global Impression (CGI)
time frame: 52 weeks

Secondary Outcomes

Measure
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
time frame: 52 weeks
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
time frame: 52 weeks
Pustular symptom score (only in subjects with pustular psoriasis)
time frame: 52 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma)
time frame: 52 weeks
sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)
time frame: 52 weeks
Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)
time frame: 52 weeks
Incidence and types of adverse events and adverse reactions
time frame: 52 weeks
Laboratory values and vital signs
time frame: 52 weeks
Profiles of pharmacokinetics
time frame: 52 weeks
Development of anti-KHK4827 antibody
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Kyowa Hakko Kirin Company, Limited.