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P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

TERMINATEDPHASE3

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

NCT01708603•Bausch Health Americas, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

Detailed Description

.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has had stable moderate to severe plaque psoriasis for at least 6 months
•Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline

Exclusion Criteria

•Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
•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 ustekinumab or any anti-IL-17 biologic therapy
•Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
•Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile

Locations (153)

Research Site

Birmingham, Alabama, United States

Research Site

Tucson, Arizona, United States

Research Site

Hot Springs, Arkansas, United States

Research Site

Bakersfield, California, United States

Research Site

Beverly Hills, California, United States

Research Site

Irvine, California, United States

Research Site

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Research Site

Sacramento, California, United States

Research Site

San Diego, California, United States

Key Dates

Start Date

August 1, 2012

Primary Completion Date

September 1, 2014

Completion Date

October 1, 2015

Last Updated

January 6, 2020

Enrollment

1,831

ACTUAL participants

Conditions

Moderate to Severe Plaque Psoriasis

Interventions

210 mg brodalumab

DRUG

140 mg brodalumab

DRUG

ustekinumab

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: January 6, 2020Data 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

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

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

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

MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

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