AsthmaPhase 2NCT01199289

A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

A Phase 2 study testing AMG 827 in people with Asthma, run by Amgen at 49 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine if AMG 827 is 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 65 years
Conditions the study is for: Asthma
What is being tested?: AMG 827
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 315 participants
Where: 49 sitesin 10 countries
Study dates: 4 Oct 2010to 21 Dec 2011
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women 18 to 65 years of age
Percent of predicted FEV1 ≥ 50% and ≤ 80%
At least 12% reversibility over pre-bronchodilator FEV1
Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Who cannot join

Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

Trial locations and contacts

49 sites in 10 countries.

Country

City, postcode or hospital

49 sites in 10 countries

United States22 sites

Research Site
Baltimore, Maryland
Research Site
Bellevue, Nebraska
Research Site
Bozeman, Montana
Research Site
Cincinnati, Ohio
Research Site
Colorado Springs, Colorado
Research Site
Dallas, Texas
Research Site
El Paso, Texas
Research Site
Encinitas, California
Research Site
High Point, North Carolina
Research Site
Huntington Beach, California
Research Site
Lake Oswego, Oregon
Research Site
Los Angeles, California
Research Site
Madison, Wisconsin
Research Site
Medford, Oregon
Research Site
North Dartmouth, Massachusetts
Research Site
Pittsburgh, Pennsylvania
Research Site
Rockville Centre, New York
Research Site
San Diego, California
Research Site
Skillman, New Jersey
Research Site
St Louis, Missouri
Research Site
Stockbridge, Georgia
Research Site
Stockton, California

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Hungary5 sites

Research Site
Edelény
Research Site
Mátraháza
Research Site
Tatabánya
Research Site
Törökbálint
Research Site
Zalaegerszeg - Pozva

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Poland4 sites

Research Site
Bialystok
Research Site
Chodzież
Research Site
Gdansk
Research Site
Wroclaw

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Austria3 sites

Research Site
Feldbach
Research Site
Hallein
Research Site
Vienna

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Belgium3 sites

Research Site
Brussels
Research Site
Leuven
Research Site
Liège

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Canada3 sites

Research Site
Calgary, Alberta
Research Site
Ottawa, Ontario
Research Site
Toronto, Ontario

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Finland3 sites

Research Site
Helsinki
Research Site
Jyväskylä
Research Site
Turku

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South Korea3 sites

Research Site
Bucheon-si
Research Site
Seoul
Research Site
Suwon

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Russia2 sites

Research Site
Moscow
Research Site
Saint Petersburg

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Netherlands1 site

Research Site
Rotterdam

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About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma

The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

Conditions: Asthma
Being tested: AMG 827, Placebo
Keywords: Amgen, chronic inflammatory disease, wheezing
Medical subject headings: Asthma, Respiratory Sounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 827Drug
SC injection.
PlaceboDrug
SC injection.

Study groups in NCT01199289
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. Receives: Drug: Placebo
AMG 827 140 mg	Experimental	Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. Receives: Drug: AMG 827
AMG 827 210 mg	Experimental	Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. Receives: Drug: AMG 827
AMG 827 280 mg	Experimental	Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. Receives: Drug: AMG 827

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 Scores to Week 12
The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment.
It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1).
The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Measured: Baseline and Week 12

Secondary outcomes (9)

Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. FEV1 was performed both pre and post-administration of bronchodilator treatment at Baseline and Week 12.
Measured: Baseline and Week 12
Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12
Measured: Baseline and Week 12
Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12
Participants recorded SABA use for 1 week prior to randomization (baseline) and the average number of days recorded was subtracted from average days of SABA use across 12 week intervention period.
Measured: Baseline to Week 12
Change From Baseline in Daily Asthma Symptom Score to Week 12
Participants recorded their daily asthma symptoms in their electronic diaries (Ediary). It included 7 questions: frequency of night time awakening, time awake at night, wheezing, shortness of breath, cough, chest tightness and activity limitation.
Daily asthma symptoms score is the sum of 7 individual scores (with the total score ranging from 0-21).
Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Measured: Baseline and Week 12
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
The AQLQ is the most commonly used asthma specific instrument and includes evaluations of both symptom and 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 (Mitchell EA et al, 1997, Juniper et al, 1994, Christie MJ et al, 1993, Juniper et al, 1993).
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 = mean of the responses to the 32 questions.
Higher scores indicate "better quality of life" and a positive change from baseline indicates improved symptoms.
Measured: Baseline and Week 12
Proportion of Asthma Symptom-free Days
Asthma symptom-free days were defined as a participant having a score of zero in their daily asthma symptom score. Asthma symptom-free days without SABA use were defined as a participant having a score of zero in their daily asthma symptom score and no SABA use.
The proportion of asthma symptom-free days was calculated as the number of asthma symptom-free days over the number of days in the double-blind treatment period (12 weeks).
Measured: Up to Week 12
Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10
Measured: Week 8 (days 60 and 64), and pre-dose on Week 10
Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10
Measured: Week 8 (days 60 and 64), and pre-dose on Week 10
Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10
Measured: Week 8 (days 60 and 64), and pre-dose on Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 201021 Dec 2011

First posted10 Sep 2010 (estimated)
Study start4 Oct 2010
Primary completion21 Dec 2011
Study completion21 Dec 2011

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 315 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01199289
Sponsor's protocol ID: 20090203
Status last verified: Oct 2021
First submitted: 5 Aug 2010
Last updated: 26 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Busse WW, Holgate S, Kerwin E, Chon Y, Feng J, Lin J, Lin SL. Randomized, double-blind, placebo-controlled study of brodalumab, a human anti-IL-17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1294-302. doi: 10.1164/rccm.201212-2318OC.
PubMed 24200404

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma
ClinicalTrials.gov ID: NCT01199289
Acronym / sponsor ID: 20090203
Conditions: Asthma
Keywords: Amgen, chronic inflammatory disease, wheezing
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 315 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 4 Oct 2010 (actual)
Primary completion: 21 Dec 2011 (actual)
Study completion: 21 Dec 2011 (actual)
First posted: 10 Sep 2010 (estimated)
Results: Posted 26 Nov 2021

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 AMG 827 is 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: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
AMG 827 140 mg	Experimental	Drug: AMG 827Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
AMG 827 210 mg	Experimental	Drug: AMG 827Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
AMG 827 280 mg	Experimental	Drug: AMG 827Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Men or women 18 to 65 years of age
Percent of predicted FEV1 ≥ 50% and ≤ 80%
At least 12% reversibility over pre-bronchodilator FEV1
Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Key exclusion criteria (3 listed)

Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

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
AMG 827SC injection.	Drug	AMG 827 140 mg, AMG 827 210 mg, AMG 827 280 mg
PlaceboSC injection.	Drug	Placebo

Primary outcome

Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12
Time frame: Baseline and Week 12
The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment. It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1). The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.

9 secondary outcomes

Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and Week 12
Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12
Time frame: Baseline and Week 12
Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12
Time frame: Baseline to Week 12
Change From Baseline in Daily Asthma Symptom Score to Week 12
Time frame: Baseline and Week 12
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
Time frame: Baseline and Week 12
Proportion of Asthma Symptom-free Days
Time frame: Up to Week 12
Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10
Time frame: Week 8 (days 60 and 64), and pre-dose on Week 10
Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10
Time frame: Week 8 (days 60 and 64), and pre-dose on Week 10
Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10
Time frame: Week 8 (days 60 and 64), and pre-dose on Week 10

Results and safety

Results posted to the registry on 26 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	77	68
AMG 827 140 mg	75	68
AMG 827 210 mg	76	71
AMG 827 280 mg	77	65

Primary outcome: Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: Score on a scale

Measure	Placebo n = 76	AMG 827 140 mg n = 73	AMG 827 210 mg n = 75	AMG 827 280 mg n = 74
Value	-0.427 (0.784)	-0.521 (0.796)	-0.512 (0.728)	-0.556 (0.810)

Placebo vs AMG 827 140 mg: LS Mean Difference: -0.068 (95% CI -0.311 to 0.175), p = 0.5838, ANCOVA
Placebo vs AMG 827 210 mg: LS Mean Difference: -0.075 (95% CI -0.316 to 0.166), p = 0.5391, ANCOVA
Placebo vs AMG 827 280 mg: LS Mean Difference: -0.113 (95% CI -0.355 to 0.129), p = 0.3583, ANCOVA

Population analysed: All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations, and had non-missing baseline and post-baseline data.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Week 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 76 (1.3%)	24 of 76 (31.6%)	0 of 77
AMG 827 140 mg	3 of 74 (4.1%)	28 of 74 (37.8%)	0 of 75
AMG 827 210 mg	1 of 76 (1.3%)	28 of 76 (36.8%)	0 of 76
AMG 827 280 mg	2 of 76 (2.6%)	28 of 76 (36.8%)	0 of 77

Limitations and caveats (from the sponsor): 10 participants from 1 site were excluded from all analysis due to major GCP violations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24200404Busse WW, Holgate S, Kerwin E, Chon Y, Feng J, Lin J, Lin SL. Randomized, double-blind, placebo-controlled study of brodalumab, a human anti-IL-17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1294-302. doi: 10.1164/rccm.201212-2318OC.
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

49 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 827 in people with Asthma, run by Amgen at 49 sites in 10 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Hungary, Poland, Austria, Belgium and 5 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 26 Nov 2021). 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 Scores to Week 12 (time frame: Baseline and Week 12). 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 NCT01199289, 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 26 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.