This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01708590
First received: September 10, 2012
Last updated: August 6, 2015
Last verified: August 2015
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Amgen:

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

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

  • Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 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 and 3 months ]
    Safety profile of brodalumab

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

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


Enrollment: 661
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Primary Completion Date: May 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 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)

  Eligibility

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708590

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

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01708590     History of Changes
Other Study ID Numbers: 20120102
2012-000651-13 ( EudraCT Number )
Study First Received: September 10, 2012
Last Updated: August 6, 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

ClinicalTrials.gov processed this record on July 21, 2017