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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

Tracking Information
First Submitted Date  ICMJE September 10, 2012
First Posted Date  ICMJE October 17, 2012
Last Update Posted Date August 24, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01708590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
  • 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 bradalumab 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab (AMG 827) in Moderate to Severe Plaque Psoriasis Subjects
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Plaque Psoriasis
Intervention  ICMJE
  • Drug: 210 mg brodalumab
    210 mg brodalumab administered subcutaneous (SC)
  • Drug: 140 mg brodalumab
    140 mg brodalumab administered subcutaneous (SC)
  • Drug: placebo
    Placebo administered subcutaneous (SC)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: 210 mg brodalumab
    • Drug: placebo
  • 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.
    Interventions:
    • Drug: 140 mg brodalumab
    • Drug: placebo
  • Placebo Comparator: placebo
    Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
    Interventions:
    • Drug: 210 mg brodalumab
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 21, 2014)
661
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2012)
600
Estimated Study Completion Date  ICMJE August 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Poland,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01708590
Other Study ID Numbers  ICMJE 20120102
2012-000651-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP