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

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: KHK4827

• Registration Number: NCT01782937
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-27
• Study First Submitted QC: 2013-01-31
• Study Start: 2013-02
• Study First Posted: 2013-02-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KHK4827	KHK4827	-

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI)	52 weeks	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

Secondary Outcome Measures

Name	Time	Method
Pustular symptom score (only in subjects with pustular psoriasis)	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)	52 weeks
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)	52 weeks
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)	52 weeks
sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)	52 weeks
Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)	52 weeks
Incidence and types of adverse events and adverse reactions	52 weeks
Laboratory values and vital signs	52 weeks
Profiles of pharmacokinetics	52 weeks	Concentration of KHK4827 in serum
Development of anti-KHK4827 antibody	52 weeks

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin; 🇯🇵 Chiyoda-ku, Tokyo, Japan