AsthmaPhase 2NCT01902290
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
A Phase 2 study testing Brodalumab in people with Asthma, run by Amgen at 161 sites in 15 countries.
Trial summary
The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Brodalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 421 participants
- Where
- 161 sitesin 15 countries
- Study dates
- 22 May 2013to 15 May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
161 sites in 15 countries.
161 sites in 15 countries
United States73 sites
Research Site
Albuquerque, New Mexico, 87109
Research Site
Arlington, Texas, 76018
Research Site
Aventura, Florida, 33180
Research Site
Bakersfield, California, 93301
Research Site
Baltimore, Maryland, 21224
Research Site
Baltimore, Maryland, 21236
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Bellevue, Nebraska, 68123
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Bellingham, Washington, 98225
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Birmingham, Alabama, 35209
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Bristol, Tennessee, 37620
Research Site
Charlotte, North Carolina, 28207
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Chicago, Illinois, 60616
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45231
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Clinton, Utah, 84015
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Colorado Springs, Colorado, 80907
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Dallas, Texas, 75231
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Decatur, Georgia, 30033
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Dublin, Ohio, 43016
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Eagle, Idaho, 83616
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El Paso, Texas, 79903
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Encinitas, California, 92024
Research Site
Glendale, Arizona, 85306
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Hialeah, Florida, 33012
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High Point, North Carolina, 27262
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Iowa City, Iowa, 52242
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Jackson, Mississippi, 39216
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Jacksonville, Florida, 32256
Research Site
Lake Oswego, Oregon, 97035
Research Site
Lawrenceville, Georgia, 30046
Research Site
Little Rock, Arkansas, 72205
Research Site
Los Angeles, California, 90025
Research Site
Los Angeles, California, 90048
Research Site
Lynn Haven, Florida, 32444
Research Site
McKinney, Texas, 75069
Research Site
Medford, Oregon, 97504
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Miami, Florida, 33173
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Middleburg Heights, Ohio, 44130
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Milwaukee, Wisconsin, 53226
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Nashville, Tennessee, 37203-1424
Research Site
Nashville, Tennessee, 37214
Research Site
Newport Beach, California, 92663
Research Site
Normal, Illinois, 61761
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
North Hollywood, California, 91606
Research Site
Ocean City, New Jersey, 07712
Research Site
Oklahoma City, Oklahoma, 73103
Research Site
Orange, California, 92868
Research Site
Orlando, Florida, 32806
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Paducah, Kentucky, 42003
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Palmdale, California, 93551
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Peoria, Illinois, 61603
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Phoenix, Arizona, 85006
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Plymouth, Minnesota, 55441
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Port Orange, Florida, 32127
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Portland, Oregon, 97202
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Rochester, New York, 14618
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Rock Hill, South Carolina, 29732
Research Site
Rolling Hills Estates, California, 90274
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78258
Research Site
San Diego, California, 92103
Research Site
San Diego, California, 92108
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San Jose, California, 95117
Research Site
Santa Monica, California, 90404
Research Site
Scottsdale, Arizona, 85251
Research Site
Spartanburg, South Carolina, 29303
Research Site
St Louis, Missouri, 63110
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Stockton, California, 95207
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Tallahassee, Florida, 32308
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Upland, Pennsylvania, 19013
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Waterbury, Connecticut, 06708
Research Site
Winston-Salem, North Carolina, 27103
Poland15 sites
Research Site
Bialystok, 15-010
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Bialystok, 15-044
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Gdynia, 81-338
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Katowice, 40-954
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Krakow, 31-011
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Krakow, 31-024
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Krakow, 31-637
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Lublin, 59-300
Research Site
Skierniewice, 96-100
Research Site
Tarnów, 33-100
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Warsaw, 01-868
Research Site
Warsaw, 02-097
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Warsaw, 02-201
Research Site
Warsaw, 04-141
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Zgierz, 95-100
Canada12 sites
Research Site
Brampton, Ontario, L6T 0G1
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Hamilton, Ontario, L8N 3Z5
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Kelowna, British Columbia, V1W 1V3
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Newmarket, Ontario, L3Y 5G8
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Sarnia, Ontario, N7T 4X3
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Sherwood Park, Alberta, T8H 0N2
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Surrey, British Columbia, V3T 0G9
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Toronto, Ontario, M5T 3A9
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Toronto, Ontario, M9V 4B4
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Trois-Rivières, Quebec, G8T 7A1
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Vancouver, British Columbia, V5Z 1M9
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Vancouver, British Columbia, V6J 1S3
Germany10 sites
Research Site
Berlin, 10717
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Berlin, 12099
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Bonn, 53119
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Cottbus, 03050
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Frankfurt am Main, 60596
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Hamburg, 22299
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Hanover, 30173
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Mainz, 55131
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Radebeul, 01445
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Rüdersdorf, 15562
Russia9 sites
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Moscow, 105077
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Moscow, 115280
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Moscow, 115446
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Moscow, 119991
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Moscow, 123182
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Moscow, 127018
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Saint Petersburg, 193231
Research Site
Saint Petersburg, 195271
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Saint Petersburg, 197022
Greece8 sites
Research Site
Alexandroupoli, 68100
Research Site
Athens, 10676
Research Site
Athens, 11527
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Athens, 11528
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Athens, 15125
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Chaidari, Athens, 12462
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Heraklion - Crete, 71110
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Thessaloniki, 57010
Italy8 sites
Research Site
Catania, 95123
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Ferrara, 44121
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Genova, 16132
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Modena, 41124
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Padova, 35128
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Pavia, 27100
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Pisa, 56124
Research Site
Tradate (VA), 21049
France7 sites
Research Site
Le Kremlin-Bicêtre, 94270
Research Site
Marseille, 13015
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Montpellier, 34295
Research Site
Pessac, 33604
Research Site
Saint-Herblain, 44805
Research Site
Strasbourg, 67091
Research Site
Tours, 37044
Ireland4 sites
Research Site
Cork
Research Site
Dublin, 15
Research Site
Dublin, 24
Research Site
Dublin
South Korea4 sites
Research Site
Bucheon-si, Gyeonggi-do, 420-767
Research Site
Incheon, 405-760
Research Site
Seoul, 142-703
Research Site
Wonju-si, Gangwon-do, 220-710
New Zealand3 sites
Research Site
Christchurch, 8140
Research Site
Dunedin, 9058
Research Site
Remuera, 1051
Taiwan3 sites
Research Site
Taipei, 10002
Research Site
Taipei, 112
Research Site
Taipei, 22050
Australia2 sites
Research Site
Nedlands, Western Australia, 6009
Research Site
New Lambton, New South Wales, 2305
About this study
Official 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
The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.
- Conditions
- Asthma
- Being tested
- Placebo, Brodalumab
- Keywords
- Inadequately controlled asthma, brodalumab, AMG 827
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Placebo administered subcutaneously
BrodalumabBiological
Also called AMG 827
Brodalumab administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo administered by subcutaneous injection on day 1, week 1, week 2 and every 2 weeks thereafter for 24 weeks. Receives: Biological: Placebo |
| Brodalumab 210 mg | Experimental | Participants received 210 mg brodalumab administered by subcutaneous injection on day 1, week 1, week 2, and every 2 weeks thereafter for 24 weeks. Receives: Biological: Brodalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24
The ACQ is a validated instrument used in clinical research and practice to evaluate asthma control/impairment.
The ACQ assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon wakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and FEV1. All seven items are scored on a 7-point scale, with 0 indicating good control and 6 indicating poor control; the total score is the mean of the seven items and ranges from 0 (totally-controlled) to 6 (extremely poorly controlled). A negative change from baseline indicates improvement. A change of 0.50 points is considered clinically meaningful and a total score of < 1.0 indicates good asthma control.
Measured: Baseline and week 24
Secondary outcomes (13)
Asthma Exacerbation Rate
The asthma exacerbation event rate is defined as the number of events per subject-year during the 24 week treatment period. An asthma exacerbation was defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study; distinct asthma exacerbations were defined as events with start dates more than 10 days apart from each other.
Measured: Baseline to week 24
Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation
The ACQ is a validated instrument used in clinical research and practice to evaluate asthma control/impairment.
The ACQ assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon wakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and FEV1. All seven items are scored on a 7-point scale, with 0 indicating good control and 6 indicating poor control; the total score is the mean of the seven items and ranges from 0 (totally-controlled) to 6 (extremely poorly controlled). A negative change from baseline indicates improvement. A change of 0.50 points is considered clinically meaningful and a total score of < 1.0 indicates good asthma control.
Measured: Baseline and week 24
Asthma Exacerbation Rate in ICS+LABA Subpopulation
The asthma exacerbation event rate is defined as the number of events per subject-year during the 24 week treatment period. An asthma exacerbation was defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study; distinct asthma exacerbations were defined as events with start dates more than 10 days apart from each other.
Measured: Baseline to week 24
Change From Baseline in Daily Asthma Symptom Score (7-day Average Score)
The Asthma Symptom Diary (ASD) consists of 23 questions answered on a handheld device, including 10 asthma symptom-related items (5 answered in the morning and 5 in the evening).
The morning diary comprises questions on 4 asthma-related symptoms (wheezing, shortness of breath, cough, chest tightness), rated on a 5-point severity scale from 0 (no symptom) to 4 (very severe symptoms), and 1 question on nocturnal awakenings, rated from 0 (did not wake up) to 4 (unable to sleep due to asthma). The evening diary has questions on the same 4 asthma-related symptoms and 1 question on limitations of activities, rated from 0 (not at all) to 4 (extremely).
The ASD daily score is computed by averaging the responses to the 10 symptom-related items, and the mean 7-day ASD score is calculated by averaging the 7 daily scores, with the final score ranging from 0 (minimal symptoms) to 4 (very severe symptoms).
Measured: Baseline and week 24
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Measured: Baseline and week 24
Change From Baseline in Daily Rescue Short-acting Beta-agonist Use
Participants were permitted allowed to use their inhaled rescue medication (SABA) as needed throughout the study and the use was captured in the daily electronic diary (eDiary).
Measured: Baseline and week 24
Time to First Asthma Exacerbation
An asthma exacerbation is defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study. Median time to first asthma exacerbation could not be estimated, the percentage of participants with an asthma exacerbation is reported.
Measured: From first dose of study drug to week 24
Number of Participants Who Experienced an Asthma Exacerbation
An asthma exacerbation is defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study.
Measured: Baseline to week 24
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score
The AQLQ is an asthma-specific instrument that includes evaluations of both symptoms and health-related quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms.
Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score was calculated as mean of the responses to the 32 questions and ranges from 1 (severe impairment) to 7 (no impairment). A positive change from baseline indicates improvement.
Measured: Baseline and week 24
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)
Peak expiratory flow rate was measured by the participant twice daily at approximately the same time each day (eg, within 1 hour of waking and immediately before bedtime) using a peak flow meter.
Measured: Baseline and week 24
Change From Baseline in Variation of Peak Flow
Peak flow was measured by the participant twice daily at approximately the same time each day (eg, within 1 hour of waking and immediately before bedtime) using a peak flow meter. The variation of peak flow is defined as the absolute value of the difference between the A.M. and P.M. peak flow in one day for an individual participant.
Measured: Baseline and week 24
Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period
Asthma symptom-free days is defined as days that a participant had a score of zero in their daily asthma symptom diary score.
The ASD consists of 23 questions answered on a handheld device, including 10 asthma symptom-related items (5 answered in the morning and 5 in the evening).
The morning diary comprises questions on 4 asthma-related symptoms (wheezing, shortness of breath, cough, chest tightness), rated on a 5-point severity scale from 0 (no symptom) to 4 (very severe symptoms), and 1 question on nocturnal awakenings, rated from 0 (did not wake up) to 4 (unable to sleep due to asthma). The evening diary has questions on the same 4 asthma-related symptoms and 1 question on limitations of activities, rated from 0 (not at all) to 4 (extremely).
The daily score is the average of the responses to the 10 items.
Measured: Baseline (the 4 weeks prior to first dose) and 4-week intervals up to week 24
Serum Brodalumab Concentration
Serum brodalumab concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) = 0.0500 µg/mL; values below the LLOQ were set to zero.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study start22 May 2013
- Primary completion15 May 2015
- Study completion15 May 2015
Why it stopped: Study terminated early due to lack of efficacy observed following interim analysis in Q2 2015. Study Closed once all sites were closed in eClinical
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin Co., Ltd., AstraZeneca
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902290
- Sponsor's protocol ID
- 20120141
- Other IDs
- 2012-003351-11
- Status last verified
- Sep 2022
- First submitted
- 22 May 2013
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019 Apr 3;3(1):22. doi: 10.1186/s41687-019-0109-2.
PubMed 30945020
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01902290
- Acronym / sponsor ID
- 20120141
- Conditions
- Asthma
- Keywords
- Inadequately controlled asthma, brodalumab, AMG 827
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to lack of efficacy observed following interim analysis in Q2 2015. Study Closed once all sites were closed in eClinical
- Enrolment
- 421 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin Co., Ltd., AstraZeneca
- Study start
- 22 May 2013 (actual)
- Primary completion
- 15 May 2015 (actual)
- Study completion
- 15 May 2015 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Posted 28 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboParticipants received placebo administered by subcutaneous injection on day 1, week 1, week 2 and every 2 weeks thereafter for 24 weeks. |
| Brodalumab 210 mg | Experimental | Biological: BrodalumabParticipants received 210 mg brodalumab administered by subcutaneous injection on day 1, week 1, week 2, and every 2 weeks thereafter for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo administered subcutaneously | Biological | Placebo |
| BrodalumabAlso: AMG 827Brodalumab administered subcutaneously | Biological | Brodalumab 210 mg |
Primary outcome
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24
Time frame: Baseline and week 24
The ACQ is a validated instrument used in clinical research and practice to evaluate asthma control/impairment. The ACQ assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon wakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and FEV1. All seven items are scored on a 7-point scale, with 0 indicating good control and 6 indicating poor control; the total score is the mean of the seven items and ranges from 0 (totally-controlled) to 6 (extremely poorly controlled). A negative change from baseline indicates improvement. A change of 0.50 points is considered clinically meaningful and a total score of < 1.0 indicates good asthma control.
13 secondary outcomes
Asthma Exacerbation Rate
Time frame: Baseline to week 24
Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation
Time frame: Baseline and week 24
Asthma Exacerbation Rate in ICS+LABA Subpopulation
Time frame: Baseline to week 24
Change From Baseline in Daily Asthma Symptom Score (7-day Average Score)
Time frame: Baseline and week 24
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline and week 24
Change From Baseline in Daily Rescue Short-acting Beta-agonist Use
Time frame: Baseline and week 24
Time to First Asthma Exacerbation
Time frame: From first dose of study drug to week 24
Number of Participants Who Experienced an Asthma Exacerbation
Time frame: Baseline to week 24
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score
Time frame: Baseline and week 24
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline and week 24
Change From Baseline in Variation of Peak Flow
Time frame: Baseline and week 24
Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period
Time frame: Baseline (the 4 weeks prior to first dose) and 4-week intervals up to week 24
Serum Brodalumab Concentration
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30945020Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019 Apr 3;3(1):22. doi: 10.1186/s41687-019-0109-2.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
161 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brodalumab in people with Asthma, run by Amgen at 161 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 161 sites in United States, Poland, Canada, Germany, Russia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24 (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.