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

December 17, 2019 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1881

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 210 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Drug: 210 mg brodalumab
210 mg brodalumab administered SC
Other Names:
  • Siliq
Experimental: 140 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Drug: 140 mg brodalumab
140 mg brodalumab administered SC
Other Names:
  • Siliq
Active Comparator: ustekinumab
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
Drug: ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Other Names:
  • Stelara
Placebo Comparator: Placebo
Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Drug: 210 mg brodalumab
210 mg brodalumab administered SC
Other Names:
  • Siliq
Drug: placebo
placebo administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
Time Frame: 12 weeks
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.
12 weeks
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Time Frame: 12 weeks
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).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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