| Primary | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG003 | AMG 827 280 mg | Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| | Units | Counts |
|---|
| Participants | - OG00076
- OG00173
- OG00275
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.427± 0.784
- OG001-0.521± 0.796
- OG002-0.512± 0.728
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.5838 | | LS Mean Difference | -0.068 | | | 2-Sided | 95 | -0.311 | 0.175 | | | | | Superiority | | | | | ANCOVA | | 0.5391 | |
|
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | Liters (L) | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG003 | AMG 827 280 mg |
|
| Secondary | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) 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. | Posted | | Mean | Standard Deviation | Litres/minute | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG003 | AMG 827 280 mg | Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | Days | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG003 | AMG 827 280 mg | |
|
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
|
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | |
|
| Secondary | 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). | All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations | Posted | | Mean | Standard Deviation | Ratio | | Up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG003 |
|
| Secondary | Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 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. | Posted | | Median | Full Range | Days | | Week 8 (days 60 and 64), and pre-dose on Week 10 | | | | ID | Title | Description |
|---|
| OG000 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 280 mg | Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| |
| Secondary | Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 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. | Posted | | Mean | Standard Deviation | µg/mL | | Week 8 (days 60 and 64), and pre-dose on Week 10 | | | | ID | Title | Description |
|---|
| OG000 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 280 mg | Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| |
| Secondary | Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 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. | Posted | | Mean | Standard Deviation | µg*day/mL | | Week 8 (days 60 and 64), and pre-dose on Week 10 | | | | ID | Title | Description |
|---|
| OG000 | AMG 827 140 mg | Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG001 | AMG 827 210 mg | Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. | | OG002 | AMG 827 280 mg | Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| |