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Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab (AMG 827) in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)

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ClinicalTrials.gov Identifier: NCT01708590
Recruitment Status : Terminated (Sponsor decision)
First Posted : October 17, 2012
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

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.


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

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
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Brodalumab
U.S. FDA Resources

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)
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)
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)
Drug: placebo
Placebo administered subcutaneous (SC)



Primary Outcome Measures :
  1. Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis

  2. Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis


Secondary Outcome Measures :
  1. Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks and 52 weeks ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis

  2. Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis

  3. Patient reported outcomes. Symptom score [ Time Frame: 12 weeks ]
    Subject-reported outcomes assessment

  4. Subject incidence of adverse events [ Time Frame: 12 weeks and 5 years and 3 months ]
    Safety profile of brodalumab

  5. Subject incidence of adverse events of interest [ Time Frame: 12 weeks and 5 years and 3 months ]
    Safety profile of brodalumab

  6. Presence of anti-brodalumab antibodies [ Time Frame: 12 weeks and 5 years ]
    Safety profile of brodalumab



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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


  Show 78 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01708590     History of Changes
Other Study ID Numbers: 20120102
2012-000651-13 ( EudraCT Number )
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Amgen:
psoriasis, brodalumab (AMG 827)

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs