P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
NCT ID: NCT01708603
Last Updated: 2020-01-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1831 participants
INTERVENTIONAL
2012-08-31
2015-10-31
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 schedule 1, 2, 3, or 4.
210 mg brodalumab
210 mg brodalumab administered SC
140 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab
140 mg brodalumab administered SC
ustekinumab
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Placebo
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab
210 mg brodalumab administered SC
placebo
Placebo administered SC
Interventions
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210 mg brodalumab
210 mg brodalumab administered SC
140 mg brodalumab
140 mg brodalumab administered SC
ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
placebo
Placebo administered SC
Eligibility Criteria
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Inclusion Criteria
* 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 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
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
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Vista, California, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Aventura, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Newnan, Georgia, United States
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Snellville, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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Carmel, Indiana, United States
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Plainfield, Indiana, United States
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South Bend, Indiana, United States
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Louisville, Kentucky, United States
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Lake Charles, Louisiana, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Rockville, Maryland, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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North Andover, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Fridley, Minnesota, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Beachwood, Ohio, United States
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Columbus, Ohio, United States
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Gahanna, Ohio, United States
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South Euclid, Ohio, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Anderson, South Carolina, United States
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Mt. Pleasant, South Carolina, 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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San Antonio, Texas, United States
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West Jordan, Utah, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Phillip, Australian Capital Territory, Australia
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Kogarah, New South Wales, Australia
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Benowa, Queensland, Australia
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Gold Coast, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Box Hill, Victoria, Australia
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Carlton, Victoria, Australia
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Parkville, Victoria, Australia
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Ajax, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Mississauga, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Brno, , Czechia
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Jihlava, , Czechia
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Nový Jičín, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Amiens, , France
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Besançon, , France
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Brest, , France
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Clermont-Ferrand, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Pessac, , France
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Pierre-Bénite, , France
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Rouen, , France
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Budapest, , Hungary
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Debrecen, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Veszprém, , Hungary
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Gdynia, , Poland
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Katowice, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Szczecin, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Córdoba, AndalucÃ-a, Spain
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Seville, AndalucÃ-a, Spain
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Alcañiz, Aragón, Spain
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Manacor, Balearic Islands, Spain
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Badalona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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A Coruña, Galicia, Spain
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Alcorcón, Madrid, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
Countries
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References
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Lebwohl MG, Armstrong AW, Alexis AF, Lain EL, Jacobson AA. Efficacy of Brodalumab in Patients with Psoriasis and Risk Factors for Treatment Failure: A Review of Post Hoc Analyses. Dermatol Ther (Heidelb). 2024 Oct;14(10):2709-2726. doi: 10.1007/s13555-024-01264-3. Epub 2024 Sep 12.
Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.
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.
McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.
Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120103
Identifier Type: -
Identifier Source: org_study_id
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