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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782937
• Other study ID #: 4827-004
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2013
• Last updated: February 12, 2015
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• KHK4827
140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin	Chiyoda-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression (CGI)	CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened	52 weeks	No
Secondary	Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)		52 weeks	No
Secondary	American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)		52 weeks	No
Secondary	Pustular symptom score (only in subjects with pustular psoriasis)		52 weeks	No
Secondary	Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma)		52 weeks	No
Secondary	sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)		52 weeks	No
Secondary	Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)		52 weeks	No
Secondary	Incidence and types of adverse events and adverse reactions		52 weeks	Yes
Secondary	Laboratory values and vital signs		52 weeks	Yes
Secondary	Profiles of pharmacokinetics	Concentration of KHK4827 in serum	52 weeks	No
Secondary	Development of anti-KHK4827 antibody		52 weeks	Yes