Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)

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

A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.

Study Type

Interventional

Enrollment (Actual)

661

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

  • Canada
      • Quebec, Canada, G1V 4X7
        • Research Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 0A2
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 3H7
        • Research Site
      • North Bay, Ontario, Canada, P1B 3Z7
        • Research Site
      • Sudbury, Ontario, Canada, P3C 1X8
        • Research Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Research Site
      • Windsor, Ontario, Canada, N8W 1E6
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Research Site
  • France
      • Nice, France, 06200
        • Research Site
      • Pessac Cedex, France, 33604
        • Research Site
      • Saint Priest en Jarez, France, 42270
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Research Site
      • Berlin, Germany, 13507
        • Research Site
      • Blankenfelde, Germany, 15831
        • Research Site
      • Bochum, Germany, 44803
        • Research Site
      • Bonn, Germany, 53105
        • Research Site
      • Buchholz, Germany, 21244
        • Research Site
      • Dülmen, Germany, 48249
        • Research Site
      • Frankfurt am Main, Germany, 60590
        • Research Site
      • Friedrichshafen, Germany, 88045
        • Research Site
      • Halle (Saale), Germany, 06120
        • Research Site
      • Hamburg, Germany, 20354
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • Münster, Germany, 48149
        • Research Site
      • Osnabrück, Germany, 49074
        • Research Site
  • Poland
      • Iwonicz Zdroj, Poland, 38-440
        • Research Site
      • Lodz, Poland, 90-436
        • Research Site
      • Lodz, Poland, 90-265
        • Research Site
      • Olsztyn, Poland, 10-228
        • Research Site
      • Poznan, Poland, 60-539
        • Research Site
      • Szczecin, Poland, 70-111
        • Research Site
      • Toruń, Poland, 87-100
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
      • Wroclaw, Poland, 50-088
        • Research Site
      • Wroclaw, Poland, 50-368
        • Research Site
      • Wroclaw, Poland, 51-318
        • Research Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Research Site
      • Bern, Switzerland, 3010
        • Research Site
      • Geneva 14, Switzerland, 1211
        • Research Site
      • Lausanne, Switzerland, 1011
        • Research Site
      • Zürich, Switzerland, 8091
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Research Site
    • California
      • Bakersfield, California, United States, 93301
        • Research Site
      • Encino, California, United States, 91436
        • Research Site
      • Los Angeles, California, United States, 90045
        • Research Site
      • San Diego, California, United States, 92123
        • Research Site
      • San Francisco, California, United States, 94118
        • Research Site
      • San Ramon, California, United States, 94583
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Research Site
    • Illinois
      • West Dundee, Illinois, United States, 60118
        • Research Site
    • Kentucky
      • Richmond, Kentucky, United States, 40475
        • Research Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Research Site
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
      • Saint Louis, Missouri, United States, 63104
        • Research Site
      • Saint Louis, Missouri, United States, 63117
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Research Site
    • New York
      • Buffalo, New York, United States, 14221
        • Research Site
      • Forest Hills, New York, United States, 11375
        • Research Site
      • Rochester, New York, United States, 14618
        • Research Site
      • Stony Brook, New York, United States, 11790
        • Research Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97223
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Research Site
      • Nashville, Tennessee, United States, 37215
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Research Site
      • Austin, Texas, United States, 78759
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • San Antonio, Texas, United States, 78229
        • 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 must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling
  • 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 stopped using certain psoriasis therapies as defined in the study protocol
  • Subject has previously used any anti-IL-17 biologic therapy

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 placebo or continued treatment. Participants are retreated at return of disease.
Drug: 210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
Other Names:
  • Siliq
Drug: placebo
Placebo administered subcutaneous (SC)
Experimental: 140 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
Drug: placebo
Placebo administered subcutaneous (SC)
Drug: 140 mg brodalumab
140 mg brodalumab administered subcutaneous (SC)
Other Names:
  • Siliq
Placebo Comparator: placebo
Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
Drug: 210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
Other Names:
  • Siliq
Drug: placebo
Placebo administered subcutaneous (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12
Time Frame: 0-12 weeks
to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.
0-12 weeks
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
Time Frame: 0 - 12 Weeks
To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12
0 - 12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52
Time Frame: Week 0 - Week 52
to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.
Week 0 - Week 52

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

August 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 10, 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

  • 20120102
  • 2012-000651-13 (EudraCT Number)

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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