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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01708629
Recruitment Status : Terminated (Sponsor decision)
First Posted : October 17, 2012
Results First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: 210 mg brodalumab Drug: 140 mg brodalumab Drug: ustekinumab Drug: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1881 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Siliq

Drug: placebo
placebo administered SC


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708629


Locations
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Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01708629    
Other Study ID Numbers: 20120104
First Posted: October 17, 2012    Key Record Dates
Results First Posted: January 3, 2020
Last Update Posted: January 3, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Bausch Health Americas, Inc.:
psoriasis, brodalumab, AMG 827
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Brodalumab
 Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs