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Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-2)

This study has been terminated.
(Sponsor decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708603
First Posted: October 17, 2012
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Amgen
  Purpose

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 Intervention Phase
Moderate to Severe Plaque Psoriasis Drug: 210 mg brodalumab Drug: 140 mg brodalumab Drug: ustekinumab Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

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

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


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

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

  • Patient reported outcomes symptom score [ Time Frame: 12 weeks ]
    Subject-reported outcomes assessment

  • Subject incidence of adverse events [ Time Frame: 12 weeks and 5 years ]
    Safety profile of brodalumab

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

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


Enrollment: 1831
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


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 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
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


  Show 155 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01708603     History of Changes
Other Study ID Numbers: 20120103
First Submitted: September 12, 2012
First Posted: October 17, 2012
Last Update Posted: October 12, 2017
Last Verified: July 2015

Keywords provided by Amgen:
psoriasis, brodalumab, AMG 827

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