Back to Search Results
Terminated/Withdrawn
Sponsor ID
20120103

Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis SubjectsAMAGINE-2

Sponsor ID
20120103
Clinicaltrials.gov ID
NCT01708603
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

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
1831
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
Bakersfield, CA, United States, 93309
Status
Recruiting
Location
Research Site
Carlton, VIC, Australia, 3053
Status
Recruiting
Location
Research Site
Denver, CO, United States, 80239
Status
Recruiting
Location
Research Site
Lake Charles, LA, United States, 70605
Status
Recruiting
Location
Research Site
Norfolk, VA, United States, 23502
Status
Recruiting
Location
Research Site
Ottawa, ON, Canada, K2G 6E2
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 75 Years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Aug 2012 - Sep 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