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

NCT02982005 | Completed Phase 3

• 1 other identifier: 4827-KR001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

KHK4827 (brodalumab)

Outcome Measures

Primary Outcomes (2)

• Psoriasis area and severity index (PASI) 75 response

  at week 12

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

  at week 12

Secondary Outcomes (11)

• PASI 50/75/90/100 response by visit

  Baseline to week 64

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

  Baseline to week 64

• Body surface area (BSA) involvement of lesion

  Baseline to week 64

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

  Baseline to week 64

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

  Baseline to week 64

Study Arms (2)

KHK4827

EXPERIMENTAL

KHK4827 administered SC

Drug: KHK4827

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

KHK4827 DRUG

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

Also known as: Brodalumab

KHK4827

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• Kyowa Kirin Korea Co., Ltd.: lead

Study Sites (1)

Korea, Republic of

Seoul, 49241, South Korea

Location

MeSH Terms

Interventions

brodalumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: January 1, 2017
• Primary Completion: August 14, 2018
• Study Completion: August 14, 2018
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)