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Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-3)

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01708629
First received: September 21, 2012
Last updated: November 20, 2015
Last verified: November 2015
September 21, 2012
November 20, 2015
September 2012
August 2014   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01708629 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
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-3

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Moderate to Severe Plaque Psoriasis
  • Drug: 210 mg brodalumab
    210 mg brodalumab administered SC
  • Drug: 140 mg brodalumab
    140 mg brodalumab administered SC
  • Drug: ustekinumab
    45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
  • Drug: placebo
    placebo administered SC
  • 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.
    Intervention: Drug: 210 mg brodalumab
  • 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.
    Intervention: Drug: 140 mg brodalumab
  • Active Comparator: ustekinumab
    Administered by subcutaneous (SC) injection per the labeled dosing regimen.
    Intervention: Drug: ustekinumab
  • Placebo Comparator: Placebo
    Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
    Interventions:
    • Drug: 210 mg brodalumab
    • Drug: placebo
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1881
October 2015
August 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 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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   France,   Greece,   Hungary,   Italy,   Latvia,   Poland,   Russian Federation,   United States
 
 
NCT01708629
20120104
Yes
Not Provided
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
November 2015

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