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

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: NCT01708603
Recruitment Status : Terminated (Sponsor decision)
First Posted : October 17, 2012
Results First Posted : January 6, 2020
Last Update Posted : January 6, 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

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1831 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-2
Study Start Date : August 2012
Actual Primary Completion Date : September 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
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
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.
Placebo Comparator: Placebo
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
 Drug: 210 mg brodalumab
210 mg brodalumab administered SC

Drug: placebo
Placebo administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 [ Time Frame: 12 weeks ]
    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).

  2. Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 [ Time Frame: 12 weeks ]
    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.

  3. Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 [ Time Frame: 12 Weeks ]
    to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.


Eligibility Criteria
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Information from the National Library of Medicine

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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): NCT01708603


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: NCT01708603    
Other Study ID Numbers: 20120103
First Posted: October 17, 2012    Key Record Dates
Results First Posted: January 6, 2020
Last Update Posted: January 6, 2020
Last Verified: January 2020
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