Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
NCT ID: NCT01101100
Last Updated: 2019-07-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
181 participants
INTERVENTIONAL
2010-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMG 827
AMG 827
AMG 827
210 mg SC or 140 mg SC
Interventions
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AMG 827
210 mg SC or 140 mg SC
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.
18 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
Newnan, Georgia, United States
Research Site
Skokie, Illinois, United States
Research Site
St Louis, Missouri, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Dallas, Texas, United States
Research Site
Webster, Texas, United States
Research Site
Kogarah, New South Wales, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Prahran, Victoria, Australia
Research Site
Hamilton, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Markham, Ontario, Canada
Research Site
Waterloo, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Aarhus, , Denmark
Research Site
Hellerup, , Denmark
Research Site
Besançon, , France
Research Site
Nice, , France
Research Site
Toulouse, , France
Countries
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References
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Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11.
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.
Lebwohl MG, Blauvelt A, Menter A, Papp KA, Guenthner S, Pillai R, Israel RJ, Jacobson A. Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. Am J Clin Dermatol. 2019 Dec;20(6):863-871. doi: 10.1007/s40257-019-00466-2.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20090403
Identifier Type: -
Identifier Source: org_study_id
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