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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

KHK4827

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KHK4827

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)

American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)

Pustular symptom score (only in subjects with pustular psoriasis)

Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma)

sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)

Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)

Incidence and types of adverse events and adverse reactions

Laboratory values and vital signs

Profiles of pharmacokinetics

Concentration of KHK4827 in serum

Development of anti-KHK4827 antibody

Full Information

NCT ID

NCT01782937

First Posted

January 27, 2013

Last Updated

February 12, 2015

Sponsor

Kyowa Kirin Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01782937

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KHK4827

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

KHK4827

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical Global Impression (CGI)

Description

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)

Time Frame

52 weeks

Title

American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)

Time Frame

52 weeks

Title

Pustular symptom score (only in subjects with pustular psoriasis)

Time Frame

52 weeks

Title

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

Title

sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)

Time Frame

52 weeks

Title

Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)

Time Frame

52 weeks

Title

Incidence and types of adverse events and adverse reactions

Time Frame

52 weeks

Title

Laboratory values and vital signs

Time Frame

52 weeks

Title

Profiles of pharmacokinetics

Description

Concentration of KHK4827 in serum

Time Frame

52 weeks

Title

Development of anti-KHK4827 antibody

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

100-8185

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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