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

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: NCT01708590
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.

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 661 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, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1
Study Start Date : August 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Brodalumab

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 Name: 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: 140 mg brodalumab
140 mg brodalumab administered subcutaneous (SC)
Other Name: Siliq

Drug: placebo
Placebo administered subcutaneous (SC)

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 Name: Siliq

Drug: placebo
Placebo administered subcutaneous (SC)




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.



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 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

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): NCT01708590


Locations
Show Show 78 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: MD Amgen
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: NCT01708590    
Other Study ID Numbers: 20120102
2012-000651-13 ( EudraCT Number )
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
Brodalumab
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs