Clinical trial NCT01708629: Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: psoriasis, brodalumab, AMG 827
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 1881
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
timeFrame: 12 weeks
measure: Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Burbank
country: United States
facility: Research Site
state: California
city: Encino
country: United States
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state: California
city: Fremont
country: United States
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state: California
city: Fullerton
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state: California
city: Irvine
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state: California
city: Los Angeles
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state: California
city: Riverside
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city: Sacramento
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city: San Diego
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city: San Diego
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city: Denver
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city: Farmington
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state: Connecticut
city: Trumbull
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city: Boca Raton
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city: Coral Gables
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city: Hollywood
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city: Jacksonville
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city: Miami
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state: Georgia
city: Atlanta
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city: Macon
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city: Boise
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city: Arlington Heights
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city: Champaign
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city: New Albany
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city: Owensboro
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city: Worcester
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city: Ann Arbor
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city: Cleveland
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city: Lake Oswego
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city: Nashville
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country: Australia
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city: Darlinghurst
country: Australia
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city: Kogarah
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city: St Leonards
country: Australia
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city: Sydney
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city: Westmead
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city: Hectorville
country: Australia
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state: South Australia
city: Fremantle
country: Australia
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state: Western Australia
city: Brugge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
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city: Edegem
country: Belgium
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city: Gent
country: Belgium
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city: Leuven
country: Belgium
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city: Liege
country: Belgium
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country: Belgium
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country: Canada
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city: Winnipeg
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city: Winnipeg
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city: Créteil
country: France
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city: Nice
country: France
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city: Poitiers
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city: Saint Priest en Jarez
country: France
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city: Toulouse Cedex 9
country: France
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city: Vandoeuvre les Nancy
country: France
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city: Chaïdári
country: Greece
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state: Athens
city: Athens
country: Greece
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city: Ioannina
country: Greece
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city: Larissa
country: Greece
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city: Maroussi
country: Greece
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city: Thessaloniki
country: Greece
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city: Thessaloniki
country: Greece
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city: Bekescsaba
country: Hungary
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city: Budapest
country: Hungary
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city: Gyula
country: Hungary
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city: Szeged
country: Hungary
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city: Szolnok
country: Hungary
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city: Szombathely
country: Hungary
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city: Bologna
country: Italy
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city: Genova
country: Italy
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city: Milano
country: Italy
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city: Milano
country: Italy
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city: Roma
country: Italy
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city: Roma
country: Italy
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city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Ventspils
country: Latvia
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Dąbrówka
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Iwonicz Zdroj
country: Poland
facility: Research Site
city: Katowice
country: Poland
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city: Krakow
country: Poland
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city: Kraków
country: Poland
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city: Lodz
country: Poland
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city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Stalowa-Wola
country: Poland
facility: Research Site
city: Swidnik
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.