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Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-3)

Primary Purpose

Plaque Psoriasis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
210 mg brodalumab
140 mg brodalumab
ustekinumab
placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring psoriasis, brodalumab, AMG 827

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

210 mg brodalumab

140 mg brodalumab

ustekinumab

Placebo

Arm Description

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

Administered by subcutaneous (SC) injection per the labeled dosing regimen.

Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

Outcomes

Primary Outcome Measures

Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).

Secondary Outcome Measures

Full Information

First Posted
September 21, 2012
Last Updated
December 17, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01708629
Brief Title
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
Acronym
AMAGINE-3
Official Title
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-3
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
This study 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
psoriasis, brodalumab, AMG 827

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1881 (Actual)

8. Arms, Groups, and Interventions

Arm Title
210 mg brodalumab
Arm Type
Experimental
Arm Description
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Arm Title
140 mg brodalumab
Arm Type
Experimental
Arm Description
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Arm Title
ustekinumab
Arm Type
Active Comparator
Arm Description
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Intervention Type
Drug
Intervention Name(s)
210 mg brodalumab
Other Intervention Name(s)
Siliq
Intervention Description
210 mg brodalumab administered SC
Intervention Type
Drug
Intervention Name(s)
140 mg brodalumab
Other Intervention Name(s)
Siliq
Intervention Description
140 mg brodalumab administered SC
Intervention Type
Drug
Intervention Name(s)
ustekinumab
Other Intervention Name(s)
Stelara
Intervention Description
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
Description
The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
Time Frame
12 weeks
Title
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Description
Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
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Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
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United States
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Research Site
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Beverly Hills
State/Province
California
ZIP/Postal Code
90212
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United States
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Research Site
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Burbank
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California
ZIP/Postal Code
91505
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United States
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Research Site
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Encino
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California
ZIP/Postal Code
91436
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United States
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Research Site
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Fremont
State/Province
California
ZIP/Postal Code
94538
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United States
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Research Site
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Fullerton
State/Province
California
ZIP/Postal Code
92835
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United States
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Irvine
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California
ZIP/Postal Code
92614
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United States
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Los Angeles
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California
ZIP/Postal Code
90036
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United States
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Riverside
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California
ZIP/Postal Code
92505
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United States
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Sacramento
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California
ZIP/Postal Code
95819
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92103
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92123
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United States
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San Francisco
State/Province
California
ZIP/Postal Code
94118
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United States
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Denver
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Colorado
ZIP/Postal Code
80220
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United States
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Farmington
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Connecticut
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06030
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United States
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Trumbull
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Connecticut
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06611
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Boca Raton
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Florida
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33486
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United States
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Coral Gables
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Florida
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33134
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United States
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Hollywood
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Florida
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33021
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United States
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Jacksonville
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Florida
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32204
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United States
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Miami
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Florida
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33144
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United States
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Ocala
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Florida
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34471
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United States
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Tamarac
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Florida
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33321
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United States
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Alpharetta
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Georgia
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30022
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United States
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Atlanta
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Georgia
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30327
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United States
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Macon
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Georgia
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31217
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United States
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Boise
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Idaho
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83704
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United States
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Arlington Heights
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Illinois
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60005
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United States
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Champaign
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Illinois
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61820
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United States
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Maywood
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Illinois
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60153
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United States
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Normal
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Illinois
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61761
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United States
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Wheaton
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Illinois
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60189
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Indianapolis
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Indiana
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46256
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United States
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New Albany
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Indiana
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47150
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Overland Park
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Kansas
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66202
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United States
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Overland Park
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Kansas
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66215
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United States
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Louisville
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Kentucky
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40217
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United States
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Owensboro
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Kentucky
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42303
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United States
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Worcester
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Massachusetts
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01605
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United States
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Ann Arbor
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Michigan
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48103
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United States
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Clarkston
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Michigan
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48346
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United States
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Clinton Township
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Michigan
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48038
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United States
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Henderson
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Nevada
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89074
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United States
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Las Vegas
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Nevada
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89144
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East Windsor
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08520
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Hoboken
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07030
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Verona
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07044
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Bronx
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New York
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10467
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United States
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New York
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New York
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10016
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Rochester
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New York
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14623
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High Point
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27262
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Cincinnati
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Ohio
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45249
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Cleveland
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Ohio
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44106
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United States
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Lake Oswego
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Oregon
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97035
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United States
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Portland
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Oregon
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97210
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United States
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Exton
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Pennsylvania
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19341
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United States
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Johnston
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Rhode Island
ZIP/Postal Code
02919
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United States
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Greer
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South Carolina
ZIP/Postal Code
29650
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United States
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Bartlett
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Tennessee
ZIP/Postal Code
38134
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United States
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Nashville
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Tennessee
ZIP/Postal Code
37205
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United States
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City
Bellaire
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Texas
ZIP/Postal Code
77401
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United States
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Research Site
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Dallas
State/Province
Texas
ZIP/Postal Code
75230
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United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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United States
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Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
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United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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United States
Facility Name
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City
Houston
State/Province
Texas
ZIP/Postal Code
77082
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United States
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City
Webster
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Texas
ZIP/Postal Code
77598
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United States
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Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
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United States
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Norfolk
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Virginia
ZIP/Postal Code
23507
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United States
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Richmond
State/Province
Virginia
ZIP/Postal Code
23294
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United States
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Spokane
State/Province
Washington
ZIP/Postal Code
99204
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United States
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Research Site
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Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
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United States
Facility Name
Research Site
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Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
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Australia
Facility Name
Research Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
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Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
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Australia
Facility Name
Research Site
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St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
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Australia
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Research Site
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Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
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Australia
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Research Site
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Westmead
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New South Wales
ZIP/Postal Code
2145
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Australia
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Research Site
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Hectorville
State/Province
South Australia
ZIP/Postal Code
5073
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Australia
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Research Site
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Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
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Australia
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Research Site
City
Brugge
ZIP/Postal Code
8000
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Belgium
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Research Site
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Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
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Belgium
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Research Site
City
Gent
ZIP/Postal Code
9000
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Belgium
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Research Site
City
Leuven
ZIP/Postal Code
3000
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Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
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Belgium
Facility Name
Research Site
City
Montigny-le-Tilleul
ZIP/Postal Code
6110
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Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
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Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
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Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1R4
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 0A2
Country
Canada
Facility Name
Research Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
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Canada
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Research Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
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Canada
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Research Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
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Canada
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Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
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Canada
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City
Toronto
State/Province
Ontario
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M5S 3B4
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Canada
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City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
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Canada
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Research Site
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 5L4
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Canada
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Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
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Canada
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Research Site
City
Saint-Hyacinthe
State/Province
Quebec
ZIP/Postal Code
J2S 6L6
Country
Canada
Facility Name
Research Site
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Research Site
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Research Site
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Research Site
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Research Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Research Site
City
Chaïdári
State/Province
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
Research Site
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Maroussi
ZIP/Postal Code
15123
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54643
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Research Site
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Research Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Research Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
48018
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1001
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1003
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV-1013
Country
Latvia
Facility Name
Research Site
City
Ventspils
ZIP/Postal Code
3601
Country
Latvia
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Research Site
City
Dąbrówka
ZIP/Postal Code
62-069
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Iwonicz Zdroj
ZIP/Postal Code
38-440
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-406
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-539
Country
Poland
Facility Name
Research Site
City
Stalowa-Wola
ZIP/Postal Code
37-450
Country
Poland
Facility Name
Research Site
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-201
Country
Poland
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620076
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121614
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410026
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
34606048
Citation
Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.
Results Reference
derived
PubMed Identifier
32207067
Citation
Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.
Results Reference
derived
PubMed Identifier
30471012
Citation
McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.
Results Reference
derived
PubMed Identifier
30328108
Citation
Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.
Results Reference
derived
PubMed Identifier
26422722
Citation
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

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