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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01708603
Registration number
NCT01708603
Ethics application status
Date submitted
12/09/2012
Date registered
17/10/2012
Titles & IDs
Public title
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
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Scientific 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
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Secondary ID [1]
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20120103
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Universal Trial Number (UTN)
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Trial acronym
AMAGINE-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Plaque Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 210 mg brodalumab
Treatment: Drugs - 140 mg brodalumab
Treatment: Drugs - ustekinumab
Treatment: Drugs - placebo
Experimental: 210 mg brodalumab - Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Experimental: 140 mg brodalumab - Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Active comparator: ustekinumab - Administered by subcutaneous (SC) injection per the labeled dosing regimen.
Placebo comparator: Placebo - Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Treatment: Drugs: 210 mg brodalumab
210 mg brodalumab administered SC
Treatment: Drugs: 140 mg brodalumab
140 mg brodalumab administered SC
Treatment: Drugs: ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Treatment: Drugs: placebo
Placebo administered SC
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
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Assessment method [1]
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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).
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Timepoint [1]
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12 weeks
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Primary outcome [2]
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Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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12 weeks
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Primary outcome [3]
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Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
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Assessment method [3]
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to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
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Timepoint [3]
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12 Weeks
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Eligibility
Key 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
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2012
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Date of last participant enrolment
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Date of last data collection
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Actual
1/10/2015
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Sample size
Target
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Accrual to date
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Final
1831
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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Research Site - Phillip
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Research Site - Kogarah
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Research Site - Parkville
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2606 - Phillip
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2217 - Kogarah
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4217 - Benowa
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4217 - Gold Coast
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4102 - Woolloongabba
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3128 - Box Hill
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3053 - Carlton
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Recruitment postcode(s) [8]
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3050 - Parkville
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Recruitment outside Australia
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bausch Health Americas, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
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Trial website
https://clinicaltrials.gov/study/NCT01708603
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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MD
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Address
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Amgen
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01708603