Loading clinical trials...

A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT02982005•Kyowa Kirin Korea Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

20 - 85 years

Sex

ALL

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
+3 more criteria

Locations (1)

Korea, Republic of

Seoul, South Korea

Key Dates

Start Date

January 1, 2017

Primary Completion Date

August 14, 2018

Completion Date

August 14, 2018

Last Updated

April 29, 2024

Enrollment

ACTUAL participants

Conditions

Moderate to Severe Plaque Psoriasis

Interventions

KHK4827

DRUG

Placebo

DRUG

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

NCT06888193

Moderate to Severe Plaque PsoriasisPsoriatic Arthritis+2 more

View study

RECRUITINGNA

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

NCT07234591

Plaque PsoriasisModerate to Severe Plaque Psoriasis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

A Phase III Study of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis

MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis