| Primary | Change From Baseline in Peripheral Eosinophil Count at Day 22 | | Participants in the PD analysis set with available data were evaluated. | Posted | | Least Squares Mean | 95% Confidence Interval | 10^9 cells/Liters | | Baseline, Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. | | OG001 | Placebo | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.199(-0.351 to -0.046)
- OG001-0.141(-0.280 to -0.002)
|
|
| | 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 |
|---|
| Mixed-model repeated measures (MMRM) analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant. | Mixed-model repeated measures | | 0.5703 | | Least Squares (LS) Mean Difference | -0.058 | | | 2-Sided | 95 | -0.265 | 0.150 | | | | | Other | | |
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Treatment-emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion. | Participants in the safety analysis set were evaluated. | Posted | | Count of Participants | | Participants | No | From first dose to Day 127 | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. | | OG001 | Placebo | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Primary | Number of Asthma Exacerbations | Asthma exacerbation was defined as follows:
-
Use of systemic corticosteroids (or a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.
OR
-
An emergency room/urgent care visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above).
OR
-
An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours due to asthma).
| Full analysis set included all participants who received etokimab or placebo and had at least one post-baseline blood eosinophils count assessment. | Posted | | Number | | asthma exacerbations | | From first dose to Day 127 | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. | | OG001 | Placebo | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Primary | Number of Participants With Positive Anti-drug Antibody | | Participants in the safety analysis set with available data were analyzed. | Posted | | Count of Participants | | Participants | No | Day 1, Day 8, Day 36, Day 85, Day 106, end of study (up to Day 127) | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. | | OG001 | Placebo | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Change From Baseline in Peripheral Eosinophil Count at Day 127 | | Participants in the PD analysis set were analyzed. | Posted | | Least Squares Mean | 95% Confidence Interval | 10^9 cells/Liters | | Baseline, Day 127 | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. | | OG001 | Placebo | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Change From Baseline in Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Day 127 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. | Participants in the full analysis set with available data were analyzed. | Posted | | Least Squares Mean | 95% Confidence Interval | Liters | | Baseline, Day 127 | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. | | OG001 | Placebo | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Day 127 | Measurement of FeNO was performed in accordance with the guidelines published by American Thoracic Society/European Respiratory Society (ATS/ERS). | Participants in the full analysis set with available data were analyzed. | Posted | | Least Squares Mean | 95% Confidence Interval | parts per billion | | Baseline, Day 127 | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. | | OG001 | Placebo | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Change From Baseline in Whole Blood Ex-vivo Induced Interferon Gamma (IFN-γ) | Blood samples for ex vivo induced IFN-γ assessment were collected in a sodium heparin tube. The measurement of ex vivo induced IFN-γ was performed using validated assay method. | Participants in the PD analysis set with available data were analyzed. | Posted | | Mean | Standard Deviation | nanograms per liter (ng/L) | | Baseline, Day 8, Day 36, Day 85, Day 106, and End of Study (up to Day 127) | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. | | OG001 | Placebo | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Maximum Observed Concentration (Cmax) of Etokimab | Cmax was obtained directly from the observed concentration versus time data. | Pharmacokinetic (PK) analysis set included all participants who received etokimab and have at least one post-dose serum concentration data value available for etokimab without any events or protocol deviation deemed to affect PK assessments. | Posted | | Mean | Standard Deviation | micrograms per milliliter (µg/mL) | | pre-dose, 0.50 hours post-start of infusion, end of infusion (EOI), EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Time to Maximum Observed Concentration (Tmax) of Etokimab | Tmax was obtained directly from the observed concentration versus time data. | Participants in the PK analysis set were analyzed. | Posted | | Median | Full Range | hours | | pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Area Under the Concentration-time Curve in Serum From Time Zero (Predose) Extrapolated to Infinite Time (AUC0-inf) of Etokimab | AUC0-inf was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant. | Participants in the PK analysis set were analyzed. | Posted | | Mean | Standard Deviation | hours*µg/mL | | pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Etokimab | AUC0-last was calculated by linear up/log down trapezoidal summation. | Participants in the PK analysis set were analyzed. | Posted | | Mean | Standard Deviation | hours*µg/mL | | pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Apparent Total Body Clearance (CL) of Etokimab | CL was calculated as dose/ AUC0-inf. | Participants in the PK analysis set were analyzed. | Posted | | Mean | Standard Deviation | L/hour | | pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Apparent Terminal Rate Constant (λz) of Etokimab | λz was determined by linear regression of the terminal points of the log-linear concentration-time curve. | Participants in the PK analysis set were analyzed. | Posted | | Mean | Standard Deviation | 1/hour | | pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Apparent Terminal Half-life (t1/2) of Etokimab | Apparent terminal half-life was determined as (natural logarithm of 2 [ln2] divided by λz). | Participants in the PK analysis set were analyzed. | Posted | | Mean | Standard Deviation | hours | | pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Volume of Distribution During Terminal Phase (Vz) of Etokimab | Vz was estimated by dividing the systemic clearance by λz. | Participants in the PK analysis set were analyzed. | Posted | | Mean | Standard Deviation | Liters | | pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |
| Secondary | Volume of Distribution at Steady State Following Intravenous Dosing (Vss) of Etokimab | Volume of distribution at steady state following intravenous dosing was calculated as [([AUMClast + ([tlast*Clast]/λz) + Clast/λz^2]/ AUC(0-inf)) - TI/ 2]*CL, Clast is last observed (quantifiable) plasma concentration, where AUMClast is the area under the moment curve from the time of dosing to Clast, tlast is the time of Clast, and TI is infusion duration. | Participants in the PK analysis set were analyzed. | Posted | | Mean | Standard Deviation | Liters | | pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion | | | | ID | Title | Description |
|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| |