Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT01902290




Registration number
NCT01902290
Ethics application status
Date submitted
22/05/2013
Date registered
18/07/2013
Date last updated
21/09/2022

Titles & IDs
Public title
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility
Secondary ID [1] 0 0
2012-003351-11
Secondary ID [2] 0 0
20120141
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Placebo
Treatment: Other - Brodalumab

Placebo comparator: Placebo - Participants received placebo administered by subcutaneous injection on day 1, week 1, week 2 and every 2 weeks thereafter for 24 weeks.

Experimental: Brodalumab 210 mg - Participants received 210 mg brodalumab administered by subcutaneous injection on day 1, week 1, week 2, and every 2 weeks thereafter for 24 weeks.


Treatment: Other: Placebo
Placebo administered subcutaneously

Treatment: Other: Brodalumab
Brodalumab administered subcutaneously
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24
Timepoint [1] 0 0
Baseline and week 24
Secondary outcome [1] 0 0
Asthma Exacerbation Rate
Timepoint [1] 0 0
Baseline to week 24
Secondary outcome [2] 0 0
Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation
Timepoint [2] 0 0
Baseline and week 24
Secondary outcome [3] 0 0
Asthma Exacerbation Rate in ICS+LABA Subpopulation
Timepoint [3] 0 0
Baseline to week 24
Secondary outcome [4] 0 0
Change From Baseline in Daily Asthma Symptom Score (7-day Average Score)
Timepoint [4] 0 0
Baseline and week 24
Secondary outcome [5] 0 0
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Timepoint [5] 0 0
Baseline and week 24
Secondary outcome [6] 0 0
Change From Baseline in Daily Rescue Short-acting Beta-agonist Use
Timepoint [6] 0 0
Baseline and week 24
Secondary outcome [7] 0 0
Time to First Asthma Exacerbation
Timepoint [7] 0 0
From first dose of study drug to week 24
Secondary outcome [8] 0 0
Number of Participants Who Experienced an Asthma Exacerbation
Timepoint [8] 0 0
Baseline to week 24
Secondary outcome [9] 0 0
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score
Timepoint [9] 0 0
Baseline and week 24
Secondary outcome [10] 0 0
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)
Timepoint [10] 0 0
Baseline and week 24
Secondary outcome [11] 0 0
Change From Baseline in Variation of Peak Flow
Timepoint [11] 0 0
Baseline and week 24
Secondary outcome [12] 0 0
Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period
Timepoint [12] 0 0
Baseline (the 4 weeks prior to first dose) and 4-week intervals up to week 24
Secondary outcome [13] 0 0
Serum Brodalumab Concentration
Timepoint [13] 0 0
Day 1 and weeks 1, 2, 4, 8, 12, 16, and 22 at predose, week 2 + 3 days, week 22 + 3, 7, 10, and 14 days

Eligibility
Key inclusion criteria
* Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced expiratory volume in 1 second (FEV1) of = 20% at screening
* Percent of predicted FEV1 = 40% and = 80% at screening
* Inhaled corticosteroid (ICS) = 200 and = 1000/µg/day fluticasone powder or equivalent
* Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at screening and baseline = 1.5 points
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
* History of allergic bronchopulmonary aspergillosis
* Respiratory infection within 4 weeks of screening or 1 week of baseline visit
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
* Subject has previously used any anti-interleukin-17 (IL17) 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
* Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
* Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2015
Sample size
Target
Accrual to date
Final
421
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Research Site - New Lambton
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
France
State/province [37] 0 0
Le Kremlin Bicetre
Country [38] 0 0
France
State/province [38] 0 0
Marseille
Country [39] 0 0
France
State/province [39] 0 0
Montpellier cedex 05
Country [40] 0 0
France
State/province [40] 0 0
Pessac Cedex
Country [41] 0 0
France
State/province [41] 0 0
Saint Herblain
Country [42] 0 0
France
State/province [42] 0 0
Strasbourg cedex
Country [43] 0 0
France
State/province [43] 0 0
Tours Cedex 9
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Bonn
Country [46] 0 0
Germany
State/province [46] 0 0
Cottbus
Country [47] 0 0
Germany
State/province [47] 0 0
Frankfurt am Main
Country [48] 0 0
Germany
State/province [48] 0 0
Hamburg
Country [49] 0 0
Germany
State/province [49] 0 0
Hannover
Country [50] 0 0
Germany
State/province [50] 0 0
Mainz
Country [51] 0 0
Germany
State/province [51] 0 0
Radebeul
Country [52] 0 0
Germany
State/province [52] 0 0
Rüdersdorf
Country [53] 0 0
Greece
State/province [53] 0 0
Alexandroupoli
Country [54] 0 0
Greece
State/province [54] 0 0
Athens
Country [55] 0 0
Greece
State/province [55] 0 0
Chaidari, Athens
Country [56] 0 0
Greece
State/province [56] 0 0
Heraklion - Crete
Country [57] 0 0
Greece
State/province [57] 0 0
Thessaloniki
Country [58] 0 0
Hong Kong
State/province [58] 0 0
Hong Kong
Country [59] 0 0
Hong Kong
State/province [59] 0 0
New Territories
Country [60] 0 0
Ireland
State/province [60] 0 0
Cork
Country [61] 0 0
Ireland
State/province [61] 0 0
Dublin
Country [62] 0 0
Italy
State/province [62] 0 0
Catania
Country [63] 0 0
Italy
State/province [63] 0 0
Ferrara
Country [64] 0 0
Italy
State/province [64] 0 0
Genova
Country [65] 0 0
Italy
State/province [65] 0 0
Modena
Country [66] 0 0
Italy
State/province [66] 0 0
Padova
Country [67] 0 0
Italy
State/province [67] 0 0
Pavia
Country [68] 0 0
Italy
State/province [68] 0 0
Pisa
Country [69] 0 0
Italy
State/province [69] 0 0
Tradate (VA)
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Bucheon-si, Gyeonggi-do
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Incheon
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seoul
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Wonju-si, Gangwon-do
Country [74] 0 0
New Zealand
State/province [74] 0 0
Christchurch
Country [75] 0 0
New Zealand
State/province [75] 0 0
Dunedin
Country [76] 0 0
New Zealand
State/province [76] 0 0
Remuera
Country [77] 0 0
Poland
State/province [77] 0 0
Bialystok
Country [78] 0 0
Poland
State/province [78] 0 0
Gdynia
Country [79] 0 0
Poland
State/province [79] 0 0
Katowice
Country [80] 0 0
Poland
State/province [80] 0 0
Krakow
Country [81] 0 0
Poland
State/province [81] 0 0
Lublin
Country [82] 0 0
Poland
State/province [82] 0 0
Skierniewice
Country [83] 0 0
Poland
State/province [83] 0 0
Tarnow
Country [84] 0 0
Poland
State/province [84] 0 0
Warszawa
Country [85] 0 0
Poland
State/province [85] 0 0
Zgierz
Country [86] 0 0
Puerto Rico
State/province [86] 0 0
San Juan
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Moscow
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Saint Petersburg
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Saint-Petersburg
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Kyowa Kirin Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
AstraZeneca
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT01902290