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

NCT ID: NCT01782937

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KHK4827

Group Type: EXPERIMENTAL

KHK4827

Intervention Type: DRUG

140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)

Interventions

KHK4827

140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Chiyoda-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

4827-004

Identifier Type: -

Identifier Source: org_study_id