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

Moderate to Severe Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982005
• Other study ID #: 4827-KR001
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: August 14, 2018

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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"

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea, Republic of	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis area and severity index (PASI) 75 response		at week 12
Primary	Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"		at week 12
Secondary	PASI 50/75/90/100 response by visit		Baseline to week 64
Secondary	sPGA of "0 (clear) or 1 (almost clear)" by visit		Baseline to week 64
Secondary	Body surface area (BSA) involvement of lesion		Baseline to week 64
Secondary	Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)		Baseline to week 64
Secondary	Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)		Baseline to week 64
Secondary	Dermatology life quality index (DLQI)		Baseline to week 64
Secondary	Treatment-emergent adverse events (TEAEs) or drug-related TEAEs		Baseline to week 64
Secondary	Laboratory values		Baseline to week 64
Secondary	Vital signs		Baseline to week 64
Secondary	Anti-KHK4827 antibodies		Baseline, Week 12, Week 24, Week 48, Week 64
Secondary	Serum KHK4827 concentration		Baseline, Week 8, Week 10, Week 12, Week 24