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Terminated/Withdrawn
Sponsor ID
20120104

Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis SubjectsAMAGINE-3

Sponsor ID
20120104
Clinicaltrials.gov ID
NCT01708629
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
brodalumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
1881
Additional Study Details

Protocol Summary

Primary Outcome Measures

Improvement in Psoriasis Area and Severity Index (PASI)

Timeframe: 12 weeks

Static Physician Global Assessment (sPGA) score

Timeframe: 12 weeks

Secondary Outcome Measures

Improvement in Psoriasis Area and Severity Index (PASI)

Timeframe: 12 weeks

Static Physician Global Assessment (sPGA) score

Timeframe: 12 weeks and 52 weeks

Patient reported outcomes symptom score

Timeframe: 12 weeks

Subject incidence of adverse events

Timeframe: 12 weeks and 5 years

Subject incidence of adverse events of interest

Timeframe: 12 weeks and 5 years

Presence of anti-brodalumab antibodies

Timeframe: 12 weeks and 5 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Arlington Heights, IL, United States, 60005
Status
Completed
Location
Research Site
Barrie, ON, Canada, L4M 6L2
Status
Recruiting
Location
Research Site
Bartlett, TN, United States, 38134
Status
Completed
Location
Research Site
Birmingham, AL, United States, 35205
Status
Recruiting
Location
Research Site
Cincinnati, OH, United States, 45249
Status
Recruiting
Location
Research Site
Clarkston, MI, United States, 48346
Status
Recruiting
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Study Info
Age
18 - 75 Years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Sep 2012 - Aug 2014
    Inclusion and Exclusion 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