A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis

Kyowa Kirin Co., Ltd.

Overview

The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Moderate to Severe Plaque Psoriasis

Interventions

KHK4827-ActiveDRUG

Single SC administration

KHK4827-PlaceboDRUG

Single SC administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Those who are ≥18 and ≤70 years of age at the time of signing the written informed consent form * Those who have involved BSA (the percentage (%) of body surface area involved with lesion) ≥10%, PASI (Psoriasis Area and Severity Index) ≥12 and sPGA (static Physician's global assessment) ≥ 3 at screening and at baseline. Exclusion Criteria: * Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis * Those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug.

Locations (25)

Site 01

Beijing, China

Site 03

Beijing, China

Site 04

Outcomes

Primary Outcomes

To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12

Time frame: Week 12

Secondary Outcomes

To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12

Time frame: Week 12

To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12

Time frame: Week 12

Data from ClinicalTrials.gov

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