Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01708629
Registration number
NCT01708629
Ethics application status
Date submitted
21/09/2012
Date registered
17/10/2012
Titles & IDs
Public title
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
Query!
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-3
Query!
Secondary ID [1]
0
0
20120104
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AMAGINE-3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
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 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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 weeks
Query!
Primary outcome [2]
0
0
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
12 weeks
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1881
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Query!
Recruitment hospital [1]
0
0
Research Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Research Site - Darlinghurst
Query!
Recruitment hospital [3]
0
0
Research Site - Kogarah
Query!
Recruitment hospital [4]
0
0
Research Site - St Leonards
Query!
Recruitment hospital [5]
0
0
Research Site - Sydney
Query!
Recruitment hospital [6]
0
0
Research Site - Westmead
Query!
Recruitment hospital [7]
0
0
Research Site - Hectorville
Query!
Recruitment hospital [8]
0
0
Research Site - Fremantle
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [5]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [6]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [7]
0
0
5073 - Hectorville
Query!
Recruitment postcode(s) [8]
0
0
6160 - Fremantle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nevada
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oregon
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Rhode Island
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
South Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Tennessee
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Utah
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Virginia
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Washington
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
West Virginia
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Brugge
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Brussels
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Edegem
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Gent
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Leuven
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Liege
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Montigny-le-Tilleul
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Alberta
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
British Columbia
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Manitoba
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Newfoundland and Labrador
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Nova Scotia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Quebec
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Créteil
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Limoges
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Nice
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Poitiers
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Saint Priest en Jarez
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Toulouse Cedex 9
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Vandoeuvre les Nancy
Query!
Country [51]
0
0
Greece
Query!
State/province [51]
0
0
Athens
Query!
Country [52]
0
0
Greece
Query!
State/province [52]
0
0
Ioannina
Query!
Country [53]
0
0
Greece
Query!
State/province [53]
0
0
Larissa
Query!
Country [54]
0
0
Greece
Query!
State/province [54]
0
0
Maroussi
Query!
Country [55]
0
0
Greece
Query!
State/province [55]
0
0
Thessaloniki
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Bekescsaba
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Budapest
Query!
Country [58]
0
0
Hungary
Query!
State/province [58]
0
0
Gyula
Query!
Country [59]
0
0
Hungary
Query!
State/province [59]
0
0
Szeged
Query!
Country [60]
0
0
Hungary
Query!
State/province [60]
0
0
Szolnok
Query!
Country [61]
0
0
Hungary
Query!
State/province [61]
0
0
Szombathely
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Bologna
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Genova
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Milano
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Roma
Query!
Country [66]
0
0
Latvia
Query!
State/province [66]
0
0
Riga
Query!
Country [67]
0
0
Latvia
Query!
State/province [67]
0
0
Ventspils
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Bialystok
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Dabrówka
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Gdansk
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Iwonicz Zdroj
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Katowice
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Krakow
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Kraków
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Lodz
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Lublin
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Poznan
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
Stalowa-Wola
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Swidnik
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Warszawa
Query!
Country [81]
0
0
Russian Federation
Query!
State/province [81]
0
0
Ekaterinburg
Query!
Country [82]
0
0
Russian Federation
Query!
State/province [82]
0
0
Moscow
Query!
Country [83]
0
0
Russian Federation
Query!
State/province [83]
0
0
Saint-Petersburg
Query!
Country [84]
0
0
Russian Federation
Query!
State/province [84]
0
0
Saratov
Query!
Country [85]
0
0
Russian Federation
Query!
State/province [85]
0
0
St. Petersburg
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bausch Health Americas, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01708629
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
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/NCT01708629