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Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
AMAGINE-3
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-3
1 other identifier
interventional
1,881
11 countries
157
Brief Summary
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2012
Typical duration for phase_3
157 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
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 21, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
January 3, 2020
CompletedJanuary 3, 2020
December 1, 2019
1.9 years
September 21, 2012
November 8, 2016
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
12 weeks
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 \[clear\] to 5 \[severe\]). Success was defined by a score of 0 or 1 (clear to almost clear).
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 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 (157)
Research Site
Birmingham, Alabama, 35205, United States
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Mobile, Alabama, 36608, United States
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Phoenix, Arizona, 85023, United States
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Beverly Hills, California, 90212, United States
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Burbank, California, 91505, United States
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Encino, California, 91436, United States
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Fremont, California, 94538, United States
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Fullerton, California, 92835, United States
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Irvine, California, 92614, United States
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Los Angeles, California, 90036, United States
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Riverside, California, 92505, United States
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Sacramento, California, 95819, 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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San Francisco, California, 94118, United States
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Denver, Colorado, 80220, United States
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Farmington, Connecticut, 06030, United States
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Trumbull, Connecticut, 06611, United States
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Boca Raton, Florida, 33486, United States
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Coral Gables, Florida, 33134, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32204, United States
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Miami, Florida, 33144, United States
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Ocala, Florida, 34471, United States
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Tamarac, Florida, 33321, United States
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Alpharetta, Georgia, 30022, United States
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Atlanta, Georgia, 30327, United States
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Macon, Georgia, 31217, United States
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Boise, Idaho, 83704, United States
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Arlington Heights, Illinois, 60005, United States
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Champaign, Illinois, 61820, United States
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Maywood, Illinois, 60153, United States
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Normal, Illinois, 61761, United States
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Wheaton, Illinois, 60189, United States
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Indianapolis, Indiana, 46256, United States
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New Albany, Indiana, 47150, United States
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Overland Park, Kansas, 66202, United States
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Overland Park, Kansas, 66215, United States
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Louisville, Kentucky, 40217, United States
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Owensboro, Kentucky, 42303, United States
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Worcester, Massachusetts, 01605, United States
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Ann Arbor, Michigan, 48103, United States
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Clarkston, Michigan, 48346, United States
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Clinton Township, Michigan, 48038, United States
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Henderson, Nevada, 89074, United States
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Las Vegas, Nevada, 89144, United States
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East Windsor, New Jersey, 08520, United States
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Hoboken, New Jersey, 07030, United States
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Verona, New Jersey, 07044, United States
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New York, New York, 10016, United States
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Rochester, New York, 14623, United States
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The Bronx, New York, 10467, United States
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High Point, North Carolina, 27262, United States
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Cincinnati, Ohio, 45249, United States
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Cleveland, Ohio, 44106, United States
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Lake Oswego, Oregon, 97035, United States
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Portland, Oregon, 97210, United States
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Exton, Pennsylvania, 19341, United States
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Johnston, Rhode Island, 02919, United States
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Greer, South Carolina, 29650, United States
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Bartlett, Tennessee, 38134, United States
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Nashville, Tennessee, 37205, United States
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Bellaire, Texas, 77401, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77082, United States
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Webster, Texas, 77598, United States
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Salt Lake City, Utah, 84132, United States
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Norfolk, Virginia, 23507, United States
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Richmond, Virginia, 23294, United States
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Spokane, Washington, 99204, United States
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Clarksburg, West Virginia, 26301, United States
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Camperdown, New South Wales, 2050, Australia
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Darlinghurst, New South Wales, 2010, Australia
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Kogarah, New South Wales, 2217, Australia
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St Leonards, New South Wales, 2065, Australia
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Sydney, New South Wales, 2000, Australia
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Westmead, New South Wales, 2145, Australia
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Hectorville, South Australia, 5073, Australia
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Fremantle, Western Australia, 6160, Australia
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Bruges, 8000, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Montigny-le-Tilleul, 6110, Belgium
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Calgary, Alberta, T2G 1B1, Canada
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Vancouver, British Columbia, V5Z 4E8, Canada
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Winnipeg, Manitoba, R3C 0N2, Canada
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Winnipeg, Manitoba, R3C 1R4, Canada
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St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
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St. John's, Newfoundland and Labrador, A1A 5E8, Canada
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Halifax, Nova Scotia, B3H 0A2, Canada
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Barrie, Ontario, L4M 6L2, Canada
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Hamilton, Ontario, L8N 1V6, Canada
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Markham, Ontario, L3P 1A8, Canada
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Richmond Hill, Ontario, L4B 1A5, Canada
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Toronto, Ontario, M3H 5Y8, Canada
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Toronto, Ontario, M5S 3B4, Canada
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Toronto, Ontario, M8X 1Y9, Canada
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Drummondville, Quebec, J2B 5L4, Canada
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Montreal, Quebec, H3Z 2S6, Canada
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Saint-Hyacinthe, Quebec, J2S 6L6, Canada
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Créteil, 94010, France
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Limoges, 87000, France
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Nice, 06200, France
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Poitiers, 86000, France
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Saint-Priest-en-Jarez, 42270, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Chaïdári, Athens, 12462, Greece
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Athens, 16121, Greece
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Ioannina, 45500, Greece
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Larissa, 41110, Greece
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Marousi, 15123, Greece
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Thessaloniki, 54643, Greece
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Thessaloniki, 56429, Greece
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Békéscsaba, 5600, Hungary
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Budapest, 1085, Hungary
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Gyula, 5700, Hungary
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Szeged, 6720, Hungary
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Szolnok, 5000, Hungary
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Szombathely, 9700, Hungary
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Bologna, 40138, Italy
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Genova, 16132, Italy
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Milan, 20122, Italy
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Milan, 48018, Italy
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Roma, 00133, Italy
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Roma, 00168, Italy
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Riga, 1001, Latvia
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Riga, 1003, Latvia
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Riga, LV-1013, Latvia
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Ventspils, 3601, Latvia
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Bialystok, 15-879, Poland
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Dąbrówka, 62-069, Poland
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Gdansk, 80-952, Poland
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Iwonicz-Zdrój, 38-440, Poland
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Katowice, 40-954, Poland
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Krakow, 30-510, Poland
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Krakow, 31-501, Poland
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Lodz, 90-242, Poland
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Lublin, 20-406, Poland
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Poznan, 60-539, Poland
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Stalowa Wola, 37-450, Poland
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Świdnik, 21-040, Poland
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Warsaw, 01-192, Poland
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Warsaw, 02-201, Poland
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Moscow, 107076, Russia
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Moscow, 119991, Russia
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Moscow, 121614, Russia
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Saint Petersburg, 191015, Russia
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Saint Petersburg, 194044, Russia
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Saratov, 410026, Russia
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Yekaterinburg, 620076, Russia
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
- OTHER
- 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 21, 2012
First Posted
October 17, 2012
Study Start
September 1, 2012
Primary Completion
August 1, 2014
Study Completion
October 1, 2015
Last Updated
January 3, 2020
Results First Posted
January 3, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share