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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
661

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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