Trial · NCT01199289

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

NCT01199289, Phase 2, Completed, Amgen; results first posted 2021-11-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma. Trials, record NCT01199289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01199289

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
NCT number: NCT01199289
Status: Completed
Phases: Phase 2
Enrollment: 315 participants, actual
Lead sponsor: Amgen
Conditions: Asthma
Interventions: AMG 827, Placebo
First posted: 2010-09-10
Last updated: 2021-11-26
Results first posted: 2021-11-26
Limitations and caveats: 10 participants from 1 site were excluded from all analysis due to major GCP violations.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12	Baseline and Week 12	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.	Score on a scale	MEAN
SECONDARY	Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Baseline and Week 12	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.	Liters (L)	MEAN
SECONDARY	Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12	Baseline and Week 12	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.	Litres/minute	MEAN
SECONDARY	Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12	Baseline to Week 12	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.	Days	MEAN
SECONDARY	Change From Baseline in Daily Asthma Symptom Score to Week 12	Baseline and Week 12	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.	Score on a scale	MEAN
SECONDARY	Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12	Baseline and Week 12	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.	Score on a scale	MEAN
SECONDARY	Proportion of Asthma Symptom-free Days	Up to Week 12	All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations	Ratio	MEAN
SECONDARY	Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10	Week 8 (days 60 and 64), and pre-dose on Week 10	The pharmacokinetic (PK) analyses set: all participants who received at least one dose of AMG 827 and who had at least 1 PK concentration measurement.	Days	MEDIAN
SECONDARY	Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10	Week 8 (days 60 and 64), and pre-dose on Week 10	The pharmacokinetic (PK) analyses set: all participants who received at least one dose of AMG 827 and who had at least 1 PK concentration measurement.	µg/mL	MEAN
SECONDARY	Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10	Week 8 (days 60 and 64), and pre-dose on Week 10	The pharmacokinetic (PK) analyses set: all participants who received at least one dose of AMG 827 and who had at least 1 PK concentration measurement.	µg*day/mL	MEAN

Source ClinicalTrials.gov

Results by group49

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12	Placebo		-0.427	Standard Deviation 0.784	Score on a scale
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12	AMG 827 140 mg		-0.521	Standard Deviation 0.796	Score on a scale
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12	AMG 827 210 mg		-0.512	Standard Deviation 0.728	Score on a scale
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12	AMG 827 280 mg		-0.556	Standard Deviation 0.810	Score on a scale
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Placebo	Pre-Bronchodilator	0.075	Standard Deviation 0.323	Liters (L)
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	AMG 827 140 mg	Pre-Bronchodilator	0.035	Standard Deviation 0.307	Liters (L)
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	AMG 827 210 mg	Pre-Bronchodilator	0.066	Standard Deviation 0.367	Liters (L)
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	AMG 827 280 mg	Pre-Bronchodilator	0.058	Standard Deviation 0.348	Liters (L)
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Placebo	Post-Bronchodilator	-0.052	Standard Deviation 0.275	Liters (L)
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	AMG 827 140 mg	Post-Bronchodilator	-0.019	Standard Deviation 0.259	Liters (L)

1 to 10 of 49Source ClinicalTrials.gov

See all 49 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	77
Overall Study	STARTED	AMG 827 140 mg	75
Overall Study	STARTED	AMG 827 210 mg	76
Overall Study	STARTED	AMG 827 280 mg	77
Overall Study	Participants Who Received Study Treatment	Placebo	76
Overall Study	Participants Who Received Study Treatment	AMG 827 140 mg	74
Overall Study	Participants Who Received Study Treatment	AMG 827 210 mg	76
Overall Study	Participants Who Received Study Treatment	AMG 827 280 mg	76
Overall Study	COMPLETED	Placebo	68
Overall Study	COMPLETED	AMG 827 140 mg	68

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events60

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Injection site erythema	General disorders	Placebo	2	76
other	Injection site erythema	General disorders	AMG 827 140 mg	5	74
other	Injection site erythema	General disorders	AMG 827 210 mg	7	76
other	Injection site erythema	General disorders	AMG 827 280 mg	7	76
other	Nasopharyngitis	Infections and infestations	Placebo	5	76
other	Nasopharyngitis	Infections and infestations	AMG 827 140 mg	5	74
other	Nasopharyngitis	Infections and infestations	AMG 827 210 mg	3	76
other	Nasopharyngitis	Infections and infestations	AMG 827 280 mg	3	76
other	Oral candidiasis	Infections and infestations	Placebo	0	76
other	Oral candidiasis	Infections and infestations	AMG 827 140 mg	1	74

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	77
Total, all-cause mortality	AMG 827 140 mg	0	75
Total, all-cause mortality	AMG 827 210 mg	0	76
Total, all-cause mortality	AMG 827 280 mg	0	77
Total, other adverse events	Placebo	24	76
Total, other adverse events	AMG 827 140 mg	28	74
Total, other adverse events	AMG 827 210 mg	28	76
Total, other adverse events	AMG 827 280 mg	28	76
Total, serious adverse events	Placebo	1	76
Total, serious adverse events	AMG 827 140 mg	3	74

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24200404	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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