Back to Search Results
Terminated/Withdrawn
Sponsor ID
20120102

Study of Efficacy, Safety, and Withdrawal and Retreatment with Brodalumab (AMG 827) in Moderate to Severe Plaque Psoriasis SubjectsAMAGINE-1

Sponsor ID
20120102
Clinicaltrials.gov ID
NCT01708590
EUCTIS ID
N/A
EudraCT ID
2012-000651-13
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
AMG 827
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
661
Additional Study Details

Protocol Summary

Primary Outcome Measures

Static Physician Global Assessment (sPGA) score

Timeframe: 12 weeks

Improvement in Psoriasis Area and Severity Index (PASI)

Timeframe: 12 weeks

Secondary Outcome Measures

Static Physician Global Assessment (sPGA) score

Timeframe: 12 weeks and 52 weeks

Improvement in Psoriasis Area and Severity Index (PASI)

Timeframe: 12 weeks

Patient reported outcomes. Symptom score

Timeframe: 12 weeks

Subject incidence of adverse events

Timeframe: 12 weeks and 5 years and 3 months

Subject incidence of adverse events of interest

Timeframe: 12 weeks and 5 years and 3 months

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, 93301
Status
Recruiting
Location
Research Site
Encino, CA, United States, 91436
Status
Recruiting
Location
Research Site
Los Angeles, CA, United States, 90045
Status
Recruiting
Location
Research Site
San Antonio, TX, United States, 78229
Status
Recruiting
Location
Research Site
Waterloo, ON, Canada, N2J 1C4
Status
Recruiting
Location
Research Site
Geneva 14, Switzerland, 1211
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 75 Years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Aug 2012 - May 2014
    Inclusion and Exclusion Criteria
    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