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A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea

Primary Purpose

Moderate to Severe Plaque Psoriasis

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

KHK4827

Placebo

About this trial

This is an interventional treatment trial for Moderate to Severe Plaque Psoriasis focused on measuring KHK4827 (brodalumab)

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject has had stable moderate to severe plaque psoriasis for at least 6 months
Subject has involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline

Exclusion Criteria:

Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations
Subject scheduled to undergo a surgical intervention during the study period
Subject has any active infection or history of infections as defined in the study protocol
Subject has known history of Crohn's disease
Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
Subject has not stopped using certain psoriasis therapies as defined in the study protocol
Subject has previously used any anti-IL-17 biologic therapy
Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study
Women of child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational product.
Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or at baseline
Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline
Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Subject has known history of alcohol and/or substance abuse within the last 12 months"

Sites / Locations

Korea, Republic of

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KHK4827

Placebo

Arm Description

KHK4827 administered SC

Placebo administered SC

Outcomes

Primary Outcome Measures

Psoriasis area and severity index (PASI) 75 response

Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"

Secondary Outcome Measures

PASI 50/75/90/100 response by visit

sPGA of "0 (clear) or 1 (almost clear)" by visit

Body surface area (BSA) involvement of lesion

Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)

Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)

Dermatology life quality index (DLQI)

Treatment-emergent adverse events (TEAEs) or drug-related TEAEs

Laboratory values

Vital signs

Anti-KHK4827 antibodies

Serum KHK4827 concentration

Full Information

NCT ID

NCT02982005

First Posted

December 1, 2016

Last Updated

September 9, 2018

Sponsor

Kyowa Kirin Korea Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02982005

Brief Title

A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea

Official Title

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Moderate to Severe Plaque Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

January 2017 (undefined)

Primary Completion Date

August 14, 2018 (Actual)

Study Completion Date

August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Kirin Korea Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks

6. Conditions and Keywords

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

Moderate to Severe Plaque Psoriasis

Keywords

KHK4827 (brodalumab)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KHK4827

Arm Type

Experimental

Arm Description

KHK4827 administered SC

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC

Intervention Type

Drug

Intervention Name(s)

KHK4827

Other Intervention Name(s)

Brodalumab

Intervention Description

Administered KHK4827 by subcutaneous (SC) injection until week 62.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.

Primary Outcome Measure Information:

Title

Psoriasis area and severity index (PASI) 75 response

Time Frame

at week 12

Title

Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"

Time Frame

at week 12

Secondary Outcome Measure Information:

Title

PASI 50/75/90/100 response by visit

Time Frame

Baseline to week 64

Title

sPGA of "0 (clear) or 1 (almost clear)" by visit

Time Frame

Baseline to week 64

Title

Body surface area (BSA) involvement of lesion

Time Frame

Baseline to week 64

Title

Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)

Time Frame

Baseline to week 64

Title

Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)

Time Frame

Baseline to week 64

Title

Dermatology life quality index (DLQI)

Time Frame

Baseline to week 64

Title

Treatment-emergent adverse events (TEAEs) or drug-related TEAEs

Time Frame

Baseline to week 64

Title

Laboratory values

Time Frame

Baseline to week 64

Title

Vital signs

Time Frame

Baseline to week 64

Title

Anti-KHK4827 antibodies

Time Frame

Baseline, Week 12, Week 24, Week 48, Week 64

Title

Serum KHK4827 concentration

Time Frame

Baseline, Week 8, Week 10, Week 12, Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject has had stable moderate to severe plaque psoriasis for at least 6 months Subject has involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline Exclusion Criteria: Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations Subject scheduled to undergo a surgical intervention during the study period Subject has any active infection or history of infections as defined in the study protocol Subject has known history of Crohn's disease Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol Subject has not stopped using certain psoriasis therapies as defined in the study protocol Subject has previously used any anti-IL-17 biologic therapy Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study Women of child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational product. Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or at baseline Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Subject has known history of alcohol and/or substance abuse within the last 12 months"

Facility Information:

Facility Name

Korea, Republic of

City

Seoul

ZIP/Postal Code

49241

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea

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