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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01708590
First received: September 10, 2012
Last updated: May 26, 2014
Last verified: May 2014

September 10, 2012
May 26, 2014
August 2012
May 2014   (final data collection date for primary outcome measure)
  • Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
  • Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
Same as current
Complete list of historical versions of study NCT01708590 on ClinicalTrials.gov Archive Site
  • Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks and 52 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
  • Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
  • Patient reported outcomes. Symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Subject-reported outcomes assessment
  • Subject incidence of adverse events [ Time Frame: 12 weeks and 5 years and 3 months ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab
  • Subject incidence of adverse events of interest [ Time Frame: 12 weeks and 5 years and 3 months ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab
  • Presence of anti-brodalumab antibodies [ Time Frame: 12 weeks and 5 years ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab
  • Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks and 52 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
  • Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy of bradalumab in subjects with moderate to severe plaque psoriasis
  • Patient reported outcomes. Symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Subject-reported outcomes assessment
  • Subject incidence of adverse events [ Time Frame: 12 weeks and 5 years ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab
  • Subject incidence of adverse events of interest [ Time Frame: 12 weeks and 5 years ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab
  • Presence of anti-brodalumab antibodies [ Time Frame: 12 weeks and 5 years ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab
Not Provided
Not Provided
 
Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Moderate to Severe Plaque Psoriasis
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
661
September 2018
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Poland,   Switzerland
 
NCT01708590
20120102, 2012-000651-13
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2014

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