| Primary | Time to First Composite Asthma Exacerbations (CompEX) Event | CompEX is defined as time from randomization to first asthma exacerbation or diary worsening during the treatment period. Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Diary worsening is based on the occurrence of prespecified changes in the following six parameters: morning peak expiratory flow rate (PEFR), evening PEFR, morning symptom score, evening symptom score, morning short-acting rescue therapy use, and evening short-acting rescue therapy use. Hazard ratio was used for the analysis. | Modified Intent-to-Treat population (mITT) population included all randomized participants who received at least one dose of study treatment. | Posted | | Median | 95% Confidence Interval | weeks | | Randomization [Week 2] to end of treatment (EOT) [Week 50] | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 | Placebo | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000NA(31.3 to NA)The data for median upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.
- OG00145.4(19.0 to NA)The data for upper limit of CI was not estimable due to insufficient number of participants with events.
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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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| | Regression, Cox | | 0.6835 | | Hazard Ratio (HR) | 0.90 | | | 2-Sided | 95 | 0.55 | 1.47 | | | | | Superiority | | |
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| Secondary | Rate of Asthma Exacerbations | The number of asthma exacerbations per year was reported for this outcome measure. Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Poisson regression was used for the analysis. | mITT population included all randomized participants who received at least one dose of study treatment. | Posted | | Number | | Asthma exacerbations per patient-year | | Randomization [Week 2] to Week 50 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 | Placebo | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Time to First Asthma Exacerbation | The time from randomization to first asthma exacerbation was measured. Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Cox regression was used for the analysis. | mITT population included all randomized participants who received at least one dose of study treatment. | Posted | | Median | 95% Confidence Interval | weeks | | Randomization [Week 2] to Week 50 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 | Placebo | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Absolute Change From Randomization in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 50 | FEV1 is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Estimates are based on a mixed model for repeated measures (MMRM) analysis with an unstructured covariance matrix. The model used the absolute change pre-bronchodilator FEV1 as the response variable and included terms for treatment arm, study visit, treatment arm by study visit interaction, baseline FEV1 as well as its interaction with study visit, in addition to the stratification factors: blood eosinophil level at visit 1 (<150, >=150 to <=300, >300 cells/microliter (uL)), number of asthma exacerbations requiring the use of systemic corticosteroids within the 12 months prior to the study entry (1 or >=2 events), and geographic region. | mITT population included all randomized participants who received at least one dose of study treatment. Overall number of participants analyzed are the number of participants available for analysis. | Posted | | Mean | Standard Error | liters | | Randomization [Week 2] to Week 50 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as intravenous (IV) infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 | Placebo | |
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| Secondary | Relative Percent Change From Randomization in Pre-Bronchodilator FEV1 at Week 50 | FEV1 was the volume of air exhaled in the first second of a forced exhalation as measured by spirometer. Measurements were performed before use of bronchodilator. Estimates are based on a mixed model for repeated measures (MMRM) analysis with an unstructured covariance matrix. The model used the relative change pre-bronchodilator FEV1 as the response variable and included terms for treatment arm, study visit, treatment arm by study visit interaction, baseline FEV1 as well as its interaction with study visit, in addition to the stratification factors: blood eosinophil level at visit 1 (<150, >=150 to <=300, >300 cells/uL), number of asthma exacerbations requiring the use of systemic corticosteroids within the 12 months prior to the study entry (1 or >=2 events), and geographic region. Relative change (%) in FEV1 = (absolute change in FEV1 / baseline FEV1) x 100. | mITT population included all randomized participants who received at least one dose of study treatment. Overall number of participants analyzed are the number of participants available for analysis. | Posted | | Mean | Standard Error | percent change | | Randomization [Week 2] to Week 50 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 |
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| Secondary | Absolute Change From Randomization in Fractional Exhaled Nitric Oxide (FeNO) at Week 50 | FeNO is a volatile marker of airway inflammation that decreases with inhaled corticosteroid treatment. The measurements recorded were according to standardized procedures by the American Thoracic Society. Estimates are based on a mixed model for repeated measures (MMRM) analysis with an unstructured covariance matrix. The model used the absolute change pre-bronchodilator FeNO as the response variable and included terms for treatment arm, study visit, treatment arm by study visit interaction, baseline FeNO as well as its interaction with study visit, in addition to the stratification factors: blood eosinophil level at visit 1 (<150, >=150 to <=300, >300 cells/uL), number of asthma exacerbations requiring the use of systemic corticosteroids within the 12 months prior to the study entry (1 or >=2 events), and geographic region. | mITT population included all randomized participants who received at least one dose of study treatment. Overall number of participants analyzed are the number of participants available for analysis. | Posted | | Mean | Standard Error | parts per billion (ppb) | | Randomization [Week 2] to Week 50 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 | Placebo |
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| Secondary | Relative Percent Change From Randomization in FeNO at Week 50 | FeNO is a volatile marker of airway inflammation that decreases with inhaled corticosteroid treatment. The measurements recorded were according to standardized procedures by the American Thoracic Society. Relative change (%) in FeNO = (absolute change in FeNO / baseline FeNO) x 100. Estimates are based on a mixed model for repeated measures (MMRM) analysis with an unstructured covariance matrix. The model used the absolute change pre-bronchodilator FeNO as the response variable and included terms for treatment arm, study visit, treatment arm by study visit interaction, baseline FeNO as well as its interaction with study visit, in addition to the stratification factors: blood eosinophil level at visit 1 (<150, >=150 to <=300, >300 cells/uL), number of asthma exacerbations requiring the use of systemic corticosteroids within the 12 months prior to the study entry (1 or >=2 events), and geographic region. | mITT population included all randomized participants who received at least one dose of study treatment. Overall number of participants analyzed are the number of participants available for analysis. | Posted | | Mean | Standard Error | percent change | | Randomization [Week 2] to Week 50 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 |
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| Secondary | Percentage of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | The safety analysis population included all randomized participants who received at least one dose of study drug during the 48-week double-blind treatment period. | Posted | | Number | | percentage of participants | | Up to approximately Week 58 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 | Placebo | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Area Under Concentration-Time Curve for the First Dosing Interval (AUClast) of MTPS9579A | | PK-evaluable population includes all participants who had at least one evaluable PK sample | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*ug/mL | | Randomization [Week 2] to Week 6 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Maximum Serum Concentration (Cmax) for the First Dosing Interval of MTPS9579A | | PK-evaluable population includes all participants who had at least one evaluable PK sample. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | 2-hour post-dose on Week 2 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Steady State Cmax of MTPS9579A | | PK-evaluable population includes all participants who had at least one evaluable PK sample | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | 2-hour post-dose on Week 14 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Maximum Time to Serum Concentration (Tmax) of MTPS9579A | | PK-evaluable population includes all participants who had at least one evaluable PK sample. | Posted | | Median | Standard Deviation | day | | Pre-dose and 2-hour post-dose on Week 2 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Trough Serum Concentration (Ctrough) Accumulation Ratio of MTPS9579A | The accumulation ratio is calculated by taking the individual ratio of the Ctrough at Week 14 to the Ctrough at Week 6. | PK-evaluable population includes all participants who had at least one evaluable PK sample. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Predose on Weeks 6 and 14 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Steady State Ctrough of MTPS9579A | | PK-evaluable population includes all participants who had at least one evaluable PK sample. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Pre-dose on Week 14 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADA) to MTPS9579A | Treatment Emergent ADA is (a) negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result, OR (b) positive ADA result at baseline and one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result. | The immunogenicity analysis population included all participants with at least one ADA assessment. | Posted | | Number | | percentage of participants | | Pre-dose Week 54 | | | | ID | Title | Description |
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| OG000 | MTPS9579A, 1800 mg | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants then received MTPS9579A, 1800 mg, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. | | OG001 | Placebo | Participants with uncontrolled moderate to severe asthma received Placebo, given as IV infusion, for 14 days in the Placebo run-in period. Participants received MTPS9579A matching placebo, given as IV infusion at randomization (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
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