Clinical trial NCT01708603: P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
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-2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: psoriasis, brodalumab, AMG 827
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 1831
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

Detailed description: .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.

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 Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
timeFrame: 12 weeks
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
timeFrame: 12 weeks
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Irvine
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state: California
city: Los Angeles
country: United States
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state: California
city: Los Angeles
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state: California
city: Sacramento
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state: California
city: San Diego
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state: California
city: San Diego
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state: California
city: Vista
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state: California
city: Denver
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state: Colorado
city: Denver
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state: Colorado
city: Denver
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state: Colorado
city: New Haven
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state: Connecticut
city: Aventura
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city: Jacksonville
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city: Miami
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city: Pembroke Pines
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city: Atlanta
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state: Georgia
city: Newnan
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city: Snellville
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city: Chicago
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state: Illinois
city: Chicago
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city: Skokie
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city: Carmel
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city: Plainfield
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city: South Bend
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city: New Orleans
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city: Silver Spring
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city: Boston
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city: North Andover
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city: Ann Arbor
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city: Fridley
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city: Columbus
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city: South Euclid
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city: Anderson
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city: Mount Pleasant
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city: Dallas
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city: Kogarah
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city: Benowa
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city: Gold Coast
country: Australia
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city: Woolloongabba
country: Australia
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city: Box Hill
country: Australia
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city: Carlton
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city: Parkville
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state: Victoria
city: Graz
country: Austria
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country: Austria
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country: Austria
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city: Wien
country: Austria
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city: Calgary
country: Canada
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city: Edmonton
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city: Vancouver
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city: Ajax
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city: Mississauga
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city: Oakville
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city: Brno
country: Czechia
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country: Czechia
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country: Czechia
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city: Amiens Cedex 1
country: France
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country: France
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city: Brest Cedex
country: France
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country: France
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city: Marseille cedex 05
country: France
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city: Montpellier cedex 5
country: France
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city: Paris Cedex 10
country: France
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city: Pessac Cedex
country: France
facility: Research Site
city: Pierre-Bénite
country: France
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city: Rouen Cedex
country: France
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Kecskemet
country: Hungary
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city: Miskolc
country: Hungary
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city: Nyiregyhaza
country: Hungary
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city: Veszprem
country: Hungary
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city: Amsterdam
country: Netherlands
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city: Breda
country: Netherlands
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city: Nijmegen
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Gdynia
country: Poland
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city: Katowice
country: Poland
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city: Lodz
country: Poland
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city: Lodz
country: Poland
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city: Lublin
country: Poland
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city: Szczecin
country: Poland
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city: Tarnow
country: Poland
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city: Warszawa
country: Poland
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city: Warszawa
country: Poland
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city: Wroclaw
country: Poland
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city: Wroclaw
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
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city: Wroclaw
country: Poland
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city: Wroclaw
country: Poland
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
state: AndalucÃ-a
city: Córdoba
country: Spain
facility: Research Site
state: AndalucÃ-a
city: Sevilla
country: Spain
facility: Research Site
state: AndalucÃ-a
city: Alcañiz
country: Spain
facility: Research Site
state: AragÃ³n
city: Manacor
country: Spain
facility: Research Site
state: Baleares
city: Badalona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: A Coruña
country: Spain
facility: Research Site
state: Galicia
city: Alcorcon
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
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.