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P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
AMAGINE-2
A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
1 other identifier
interventional
1,831
10 countries
147
Brief Summary
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2012
Typical duration for phase_3
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
January 6, 2020
CompletedJanuary 6, 2020
January 1, 2020
2.1 years
September 12, 2012
October 31, 2016
January 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
12 weeks
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
12 weeks
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
12 Weeks
Study Arms (4)
210 mg brodalumab
EXPERIMENTALAdministered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab
EXPERIMENTALAdministered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
ustekinumab
ACTIVE COMPARATORAdministered by subcutaneous (SC) injection per the labeled dosing regimen.
Placebo
PLACEBO COMPARATORAdministered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Interventions
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (153)
Research Site
Birmingham, Alabama, 35233, United States
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Tucson, Arizona, 85710, United States
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Hot Springs, Arkansas, 71913, United States
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Bakersfield, California, 93309, United States
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Beverly Hills, California, 90211, United States
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Irvine, California, 92697, United States
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Los Angeles, California, 90027, United States
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Los Angeles, California, 90045, United States
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Sacramento, California, 95816, United States
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San Diego, California, 92103, United States
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San Diego, California, 92123, United States
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Vista, California, 92083, United States
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Denver, Colorado, 80209, United States
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Denver, Colorado, 80210, United States
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Denver, Colorado, 80239, United States
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New Haven, Connecticut, 06511, United States
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Aventura, Florida, 33180, United States
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Jacksonville, Florida, 32216, United States
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Miami, Florida, 33136, United States
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Pembroke Pines, Florida, 33028, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30342, United States
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Newnan, Georgia, 30263, United States
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Snellville, Georgia, 30078, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60654, United States
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Skokie, Illinois, 60077, United States
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Carmel, Indiana, 46032, United States
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Plainfield, Indiana, 46168, United States
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South Bend, Indiana, 46617, United States
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Louisville, Kentucky, 40202, United States
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Lake Charles, Louisiana, 70601, United States
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Lake Charles, Louisiana, 70605, United States
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New Orleans, Louisiana, 70112, United States
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Rockville, Maryland, 20850, United States
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Silver Spring, Maryland, 20902, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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North Andover, Massachusetts, 01845, United States
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Ann Arbor, Michigan, 48109, United States
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Fridley, Minnesota, 55432, United States
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Omaha, Nebraska, 68144, United States
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Henderson, Nevada, 89074, United States
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Brooklyn, New York, 11209, United States
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New York, New York, 10029, United States
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Rochester, New York, 14625, United States
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Charlotte, North Carolina, 28210, United States
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Durham, North Carolina, 27710, United States
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Raleigh, North Carolina, 27612, United States
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Winston-Salem, North Carolina, 27103, United States
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Beachwood, Ohio, 44122, United States
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Columbus, Ohio, 43212, United States
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Gahanna, Ohio, 43230, United States
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South Euclid, Ohio, 44118, United States
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Portland, Oregon, 97239, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Anderson, South Carolina, 29621, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Austin, Texas, 78759, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77065, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78249, United States
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West Jordan, Utah, 84088, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24016, United States
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Seattle, Washington, 98101, United States
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Phillip, Australian Capital Territory, 2606, Australia
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Kogarah, New South Wales, 2217, Australia
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Benowa, Queensland, 4217, Australia
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Gold Coast, Queensland, 4217, Australia
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Woolloongabba, Queensland, 4102, Australia
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Box Hill, Victoria, 3128, Australia
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Carlton, Victoria, 3053, Australia
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Parkville, Victoria, 3050, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Vienna, 1030, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Calgary, Alberta, T3A 2N1, Canada
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Edmonton, Alberta, T5K 1X3, Canada
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Surrey, British Columbia, V3R 6A7, Canada
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Vancouver, British Columbia, V5Z 3Y1, Canada
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Ajax, Ontario, L1S 7K8, Canada
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Greater Sudbury, Ontario, P3E 1H5, Canada
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Mississauga, Ontario, L5H 1G9, Canada
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Oakville, Ontario, L6J 7W5, Canada
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Ottawa, Ontario, K2G 6E2, Canada
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Peterborough, Ontario, K9J 1Z2, Canada
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Waterloo, Ontario, N2J 1C4, Canada
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Windsor, Ontario, N8W 1E6, Canada
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Windsor, Ontario, N8W 5L7, Canada
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Montreal, Quebec, H3H 1V4, Canada
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Brno, 656 91, Czechia
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Jihlava, 586 33, Czechia
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Nový Jičín, 741 01, Czechia
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Prague, 100 34, Czechia
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Prague, 150 06, Czechia
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Prague, 180 81, Czechia
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Ústí nad Labem, 401 13, Czechia
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Amiens, 80504, France
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Besançon, 25030, France
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Brest, 29609, France
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Clermont-Ferrand, 63000, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Paris, 75475, France
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Pessac, 33604, France
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Pierre-Bénite, 69495, France
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Rouen, 76031, France
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Budapest, 1036, Hungary
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Debrecen, 4012, Hungary
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Kecskemét, 6000, Hungary
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Miskolc, 3529, Hungary
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Nyíregyháza, 4400, Hungary
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Veszprém, 8200, Hungary
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Amsterdam, 1105 AZ, Netherlands
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Breda, 4818 CK, Netherlands
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Nijmegen, 6525 GL, Netherlands
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Rotterdam, 3015 CA, Netherlands
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Gdynia, 81-384, Poland
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Katowice, 40-040, Poland
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Lodz, 90-265, Poland
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Lodz, 90-436, Poland
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Lublin, 20-080, Poland
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Szczecin, 70-332, Poland
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Tarnów, 33-100, Poland
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Warsaw, 02-106, Poland
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Warsaw, 04-141, Poland
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Wroclaw, 50-088, Poland
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Wroclaw, 50-368, Poland
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Wroclaw, 51-153, Poland
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Wroclaw, 51-318, Poland
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Wroclaw, 53-658, Poland
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Coimbra, 3000-075, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4050, Portugal
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Porto, 4200-319, Portugal
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Córdoba, AndalucÃ-a, 14004, Spain
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Seville, AndalucÃ-a, 41009, Spain
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Alcañiz, Aragón, 44600, Spain
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Manacor, Balearic Islands, 07500, Spain
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Badalona, Cataluña, 08916, Spain
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Barcelona, Cataluña, 08003, Spain
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Barcelona, Cataluña, 08025, Spain
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Barcelona, Cataluña, 08036, Spain
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Barcelona, Cataluña, 08041, Spain
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A Coruña, Galicia, 15001, Spain
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Alcorcón, Madrid, 28922, Spain
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Valencia, Valencia, 46014, Spain
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Madrid, 28006, Spain
Related Publications (6)
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.
PMID: 39264399DERIVEDKokolakis 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.
PMID: 34606048DERIVEDGottlieb 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.
PMID: 32207067DERIVEDMcMichael 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.
PMID: 30471012DERIVEDLangley 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.
PMID: 30328108DERIVEDLebwohl 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.
PMID: 26422722DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2012
First Posted
October 17, 2012
Study Start
August 1, 2012
Primary Completion
September 1, 2014
Study Completion
October 1, 2015
Last Updated
January 6, 2020
Results First Posted
January 6, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share