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P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis (AMAGINE-2)

Primary Purpose

Moderate to Severe 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 Moderate to Severe 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 subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

Outcomes

Primary Outcome Measures

Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2012
Last Updated
January 3, 2020
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01708603
Brief Title
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
Acronym
AMAGINE-2
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-2
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe 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
1831 (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 subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Intervention Type
Drug
Intervention Name(s)
210 mg brodalumab
Intervention Description
210 mg brodalumab administered SC
Intervention Type
Drug
Intervention Name(s)
140 mg brodalumab
Intervention Description
140 mg brodalumab administered SC
Intervention Type
Drug
Intervention Name(s)
ustekinumab
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 Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
Description
Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
Time Frame
12 weeks
Title
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
Description
to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
Time Frame
12 weeks
Title
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
Description
to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
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
35233
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Research Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Research Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Research Site
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
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United States
Facility Name
Research Site
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
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United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
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United States
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Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
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United States
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Research Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
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United States
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Research Site
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
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United States
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Research Site
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Miami
State/Province
Florida
ZIP/Postal Code
33136
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United States
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Research Site
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Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
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United States
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Research Site
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Tampa
State/Province
Florida
ZIP/Postal Code
33612
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United States
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Research Site
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Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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United States
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Research Site
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Newnan
State/Province
Georgia
ZIP/Postal Code
30263
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United States
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Research Site
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Snellville
State/Province
Georgia
ZIP/Postal Code
30078
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United States
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Research Site
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Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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United States
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Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
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United States
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Research Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
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United States
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Research Site
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Carmel
State/Province
Indiana
ZIP/Postal Code
46032
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United States
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Research Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
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United States
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Research Site
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South Bend
State/Province
Indiana
ZIP/Postal Code
46617
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United States
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Research Site
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Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
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United States
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Research Site
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Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
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United States
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City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
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United States
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New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
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United States
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Rockville
State/Province
Maryland
ZIP/Postal Code
20850
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United States
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Research Site
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Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
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United States
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Research Site
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Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
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United States
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Research Site
City
North Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
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United States
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Research Site
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Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
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United States
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Research Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
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United States
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Research Site
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Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
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United States
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Research Site
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Henderson
State/Province
Nevada
ZIP/Postal Code
89074
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United States
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Research Site
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Brooklyn
State/Province
New York
ZIP/Postal Code
11209
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United States
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Research Site
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New York
State/Province
New York
ZIP/Postal Code
10029
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United States
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Rochester
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New York
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14625
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United States
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Charlotte
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North Carolina
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28210
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United States
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Durham
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North Carolina
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27710
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United States
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Raleigh
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North Carolina
ZIP/Postal Code
27612
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United States
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Winston-Salem
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North Carolina
ZIP/Postal Code
27103
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United States
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Beachwood
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Ohio
ZIP/Postal Code
44122
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United States
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Columbus
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Ohio
ZIP/Postal Code
43212
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United States
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Gahanna
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Ohio
ZIP/Postal Code
43230
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United States
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South Euclid
State/Province
Ohio
ZIP/Postal Code
44118
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United States
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City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
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Research Site
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Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Research Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Research Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Research Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Research Site
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Research Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Research Site
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Research Site
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Research Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Research Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Research Site
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Research Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
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Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
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Research Site
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Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
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Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3Y1
Country
Canada
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Research Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
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Research Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Research Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
Research Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 1Z2
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 1H5
Country
Canada
Facility Name
Research Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Research Site
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Research Site
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Research Site
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Research Site
City
Amiens Cedex 1
ZIP/Postal Code
80504
Country
France
Facility Name
Research Site
City
Besancon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Research Site
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Research Site
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Research Site
City
Marseille cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Research Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Research Site
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Research Site
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Research Site
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Research Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 GL
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3015 CA
Country
Netherlands
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Research Site
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
51-153
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
53-658
Country
Poland
Facility Name
Research Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4050
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Research Site
City
Cordoba
State/Province
AndalucÃ-a
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Córdoba
State/Province
AndalucÃ-a
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Sevilla
State/Province
AndalucÃ-a
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Alcañiz
State/Province
Aragón
ZIP/Postal Code
44600
Country
Spain
Facility Name
Research Site
City
Manacor
State/Province
Baleares
ZIP/Postal Code
07500
Country
Spain
Facility Name
Research Site
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Research Site
City
A Coruña
State/Province
Galicia
ZIP/Postal Code
15001
Country
Spain
Facility Name
Research Site
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain

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

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

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