Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects
NCT ID: NCT01708590
Last Updated: 2020-01-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
661 participants
INTERVENTIONAL
2012-08-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
placebo
Placebo administered subcutaneous (SC)
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.
140 mg brodalumab
140 mg brodalumab administered subcutaneous (SC)
placebo
Placebo administered subcutaneous (SC)
placebo
Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
placebo
Placebo administered subcutaneous (SC)
Interventions
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210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
140 mg brodalumab
140 mg brodalumab administered subcutaneous (SC)
placebo
Placebo administered subcutaneous (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Bakersfield, California, United States
Research Site
Encino, California, United States
Research Site
Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Ramon, California, United States
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Santa Monica, California, United States
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Alpharetta, Georgia, United States
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West Dundee, Illinois, United States
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Richmond, Kentucky, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Fort Gratiot, Michigan, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Buffalo, New York, United States
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Forest Hills, New York, United States
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Rochester, New York, United States
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Stony Brook, New York, United States
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Wilmington, North Carolina, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Rapid City, South Dakota, United States
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Goodlettsville, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Surrey, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
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North Bay, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
Research Site
Nice, , France
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Pessac, , France
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Saint-Priest-en-Jarez, , France
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Toulouse, , France
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Berlin, , Germany
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Berlin, , Germany
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Blankenfelde, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Buchholz, , Germany
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Dülmen, , Germany
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Frankfurt am Main, , Germany
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Friedrichshafen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
Research Site
Kiel, , Germany
Research Site
Münster, , Germany
Research Site
Osnabrück, , Germany
Research Site
Iwonicz-Zdrój, , Poland
Research Site
Lodz, , Poland
Research Site
Lodz, , Poland
Research Site
Olsztyn, , Poland
Research Site
Poznan, , Poland
Research Site
Szczecin, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Basel, , Switzerland
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Bern, , Switzerland
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Geneva, , Switzerland
Research Site
Lausanne, , Switzerland
Research Site
Zurich, , Switzerland
Countries
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References
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Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-000651-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120102
Identifier Type: -
Identifier Source: org_study_id
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