| Primary | Change From Baseline in Asthma Control Questionnaire (ACQ) Score | The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. | | OG001 | Placebo | Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.513± 0.0970
- OG0010.001± 0.1487
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| | 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 |
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| | Mixed Models Analysis | | 0.005 | | Mean Difference (Net) | -0.514 | | | 2-Sided | 90 | -0.811 | -0.217 | | | | No | Superiority or Other | | |
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| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) | FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis. | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. | | OG001 | Placebo | Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Change in Asthma Quality of Life Questionnaire (AQLQ) Score | The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. | | OG001 | Placebo | Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Morning and Evening Peak Expiratory Flow (PEF) Rate | Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary. | No analysis was performed on the collected data with the eDiary device due to overall poor data quality (values were obtained that were not physiologically possible) and high variability. Therefore, there is no data to present for this outcome measure. | Posted | | | | | | Baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. | | OG001 | Placebo | Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Change From Baseline in Maximum Expiratory Flow | Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis. | Posted | | Mean | Standard Deviation | L/sec | | Baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. | | OG001 | Placebo | Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies | Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed. | All randomized participants | Posted | | Number | | Participants | | 12 weeks | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. | | OG001 | Placebo | Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte | Blood samples were obtained to measure Cmax,ss. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis. | Posted | | Mean | Standard Deviation | ng/mL | | days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte | Blood samples were obtained to measure Cmax,ss. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis. | Posted | | Mean | Standard Deviation | ug/mL | | days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte | Blood samples were obtained to measure Cmin,ss. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis. | Posted | | Mean | Standard Deviation | ng/mL | | days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte | Blood samples were obtained to measure Cmin,ss. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis. | Posted | | Mean | Standard Deviation | ug/mL | | days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. |
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| Secondary | Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments. | Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis. | Posted | | Least Squares Mean | Standard Error | parts per billion (ppb) | | baseline, 12 weeks | | | | ID | Title | Description |
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| OG000 | QBX258 | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. | | OG001 | Placebo | Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. |
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