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

NCT ID: NCT04614298

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-11-30

Brief Summary

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

Detailed Description

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Conditions

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Moderate to Severe Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KHK4827 210 mg SC (Subcutaneous)

Single SC administration

Group Type EXPERIMENTAL

KHK4827-Active

Intervention Type DRUG

Single SC administration

Placebo SC

Single SC administration

Group Type PLACEBO_COMPARATOR

KHK4827-Placebo

Intervention Type DRUG

Single SC administration

Interventions

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KHK4827-Active

Single SC administration

Intervention Type DRUG

KHK4827-Placebo

Single SC administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin China Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site 01

Beijing, , China

Site Status

Site 03

Beijing, , China

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Site 04

Beijing, , China

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Site 10

Beijing, , China

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Site 11

Beijing, , China

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Site 12

Beijing, , China

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Site 21

Beijing, , China

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Site 07

Changchun, , China

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Site 13

Changchun, , China

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Site 14

Chongqing, , China

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Site 09

Hangzhou, , China

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Site 17

Hangzhou, , China

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Site 24

Hangzhou, , China

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Site 25

Nanjing, , China

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Site 02

Shanghai, , China

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Site 05

Shanghai, , China

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Site 08

Shanghai, , China

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Site 06

Tianjin, , China

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Site 22

Tianjin, , China

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Site 23

Ürümqi, , China

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Site 16

Wenzhou, , China

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Site 19

Wuhan, , China

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Site 20

Wuhan, , China

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Site 15

Xi'an, , China

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Site 18

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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4827-CN001

Identifier Type: -

Identifier Source: org_study_id

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