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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001927-15 | EudraCT Number |
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Met pre-specified criteria for futility at interim analysis
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The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).
The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control.
The duration of participant participation in the study is planned to be up to approximately 30 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEV-48574 | Experimental | Participants will receive the investigational medicinal product (IMP) loading doses on the day of randomization and the subsequent corresponding IMP maintenance doses every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses). |
|
| Placebo | Placebo Comparator | Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEV-48574 | Drug | subcutaneous infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period | The LoAC was defined as any 1 of the following during the treatment period: - morning peak expiratory flow (PEF) decrease ≥30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second of exhalation (FEV1) decrease ≥20% from baseline on 2 consecutive days; - increase in short-acting beta-agonist (SABA)/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in inhaled corticosteroids (ICS) dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma emergency room (ER) visit or hospitalization. | From randomization (Week 0) until Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to LoAC During the Treatment Period | Time (in days) from randomization to LoAC during the treatment period is the interval from randomization to the occurrence of the LoAC. The LoAC was defined as any 1 of the following during the treatment period: - morning PEF decrease ≥30% from baseline on 2 consecutive days or morning handheld FEV1 decrease ≥20% from baseline on 2 consecutive days; - increase in SABA/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in ICS dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma ER visit or hospitalization. |
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Inclusion Criteria:
NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
NOTE- Additional criteria apply, please contact the investigator for more information
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 14884 | Birmingham | Alabama | 35209 | United States | ||
| Teva Investigational Site 14915 |
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)
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A total of 65 participants were randomly assigned to treatment (33 participants in the TEV-48574 group and 32 participants in the placebo group). Of these, 64 participants received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to TEV-48574 subcutaneously (SC) every 2 weeks for a total of 8 doses. |
| FG001 | TEV-48574 | Participants received TEV-48574 loading dose SC on the day of randomization and the subsequent corresponding TEV-48574 maintenance doses SC every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2021 | Dec 15, 2022 |
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| Drug |
Matching Placebo |
|
| From randomization (Week 0) until Week 16 |
| Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16 | The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. | Baseline, Week 16 |
| Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16 | FEV1 (measured by handheld spirometer) is the volume of air that can be forcibly exhaled from the lungs in the first second. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. | Baseline, Week 16 |
| Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16 | Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily. | Baseline, Week 16 |
| Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period | The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma. Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer). | From randomization (Week 0) until Week 16 |
| Time From Randomization to First CAE During the Treatment Period for Participants With CAE | The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma. Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer). | From randomization (Week 0) until Week 16 |
| Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16 | Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning. | Baseline, Week 16 |
| Percent Change in ICS Dose During the Treatment Period | The ICS dose was not collected in the participant diary as planned. | From randomization (Week 0) until Week 16 |
| Change From Baseline in Forced Vital Capacity (FVC) at Week 16 | FVC (measured by handheld spirometer) is the volume of air that can be forcibly and completely blown out after full inspiration, measured in liters. | Baseline, Week 16 |
| Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16 | The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC | Baseline, Week 16 |
| Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16 | FeNO was performed prior to the on-site spirometry. | Baseline, Week 16 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered treatment emergent (TEAEs) if onset occurred on or after the first dose date. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. AEs include clinically significant changes from baseline in any one of the following categories: clinical laboratory test results, vital signs, ECG findings. | From randomization (Week 0) until Week 24 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Teva Investigational Site 14914 | Bakersfield | California | 93301 | United States |
| Teva Investigational Site 15234 | Huntington Beach | California | 92647 | United States |
| Teva Investigational Site 14896 | Los Angeles | California | 90025 | United States |
| Teva Investigational Site 14918 | Los Angeles | California | 90025 | United States |
| Teva Investigational Site 14913 | Los Angeles | California | 90048 | United States |
| Teva Investigational Site 14910 | Rolling Hills Estates | California | 90274-7604 | United States |
| Teva Investigational Site 14907 | San Diego | California | 92123 | United States |
| Teva Investigational Site 14891 | San Jose | California | 95117 | United States |
| Teva Investigational Site 15231 | Stockton | California | 95207 | United States |
| Teva Investigational Site 14916 | Walnut Creek | California | 94598 | United States |
| Teva Investigational Site 14878 | Westminster | California | 92683 | United States |
| Teva Investigational Site 14895 | Colorado Springs | Colorado | 80907 | United States |
| Teva Investigational Site 14917 | Denver | Colorado | 80246 | United States |
| Teva Investigational Site 15222 | Coral Gables | Florida | 33134 | United States |
| Teva Investigational Site 15223 | Cutler Bay | Florida | 33189 | United States |
| Teva Investigational Site 14911 | Hialeah | Florida | 33012 | United States |
| Teva Investigational Site 15225 | Hialeah | Florida | 33015 | United States |
| Teva Investigational Site 14900 | Miami | Florida | 33134 | United States |
| Teva Investigational Site 14883 | Miami | Florida | 33173 | United States |
| Teva Investigational Site 14908 | Panama City | Florida | 32405 | United States |
| Teva Investigational Site 14894 | Tallahassee | Florida | 32308-4355 | United States |
| Teva Investigational Site 15224 | Tampa | Florida | 33607 | United States |
| Teva Investigational Site 14924 | Evansville | Indiana | 47713 | United States |
| Teva Investigational Site 14897 | Kansas City | Kansas | 66160 | United States |
| Teva Investigational Site 15220 | Baltimore | Maryland | 21236 | United States |
| Teva Investigational Site 14877 | North Dartmouth | Massachusetts | 02747-3322 | United States |
| Teva Investigational Site 14922 | St Louis | Missouri | 63110 | United States |
| Teva Investigational Site 14893 | St Louis | Missouri | 63141 | United States |
| Teva Investigational Site 14904 | Missoula | Montana | 59808 | United States |
| Teva Investigational Site 14912 | Bellevue | Nebraska | 68123-4303 | United States |
| Teva Investigational Site 14903 | Lincoln | Nebraska | 68505-2343 | United States |
| Teva Investigational Site 15227 | Skillman | New Jersey | 08558 | United States |
| Teva Investigational Site 15221 | Charlotte | North Carolina | 28277 | United States |
| Teva Investigational Site 15226 | Monroe | North Carolina | 28112 | United States |
| Teva Investigational Site 14882 | Raleigh | North Carolina | 27607 | United States |
| Teva Investigational Site 14887 | Wilmington | North Carolina | 28401 | United States |
| Teva Investigational Site 14889 | Cincinnati | Ohio | 45231 | United States |
| Teva Investigational Site 14886 | Dublin | Ohio | 43016 | United States |
| Teva Investigational Site 14901 | Toledo | Ohio | 43617 | United States |
| Teva Investigational Site 14888 | Edmond | Oklahoma | 73034 | United States |
| Teva Investigational Site 14880 | Oklahoma City | Oklahoma | 73112-4432 | United States |
| Teva Investigational Site 14923 | Philadelphia | Pennsylvania | 19140 | United States |
| Teva Investigational Site 14890 | Charleston | South Carolina | 29406 | United States |
| Teva Investigational Site 14925 | Allen | Texas | 75013 | United States |
| Teva Investigational Site 15230 | Austin | Texas | 78759 | United States |
| Teva Investigational Site 14909 | Dallas | Texas | 75231 | United States |
| Teva Investigational Site 14902 | El Paso | Texas | 79903-3508 | United States |
| Teva Investigational Site 14919 | Fort Worth | Texas | 76244 | United States |
| Teva Investigational Site 14921 | Houston | Texas | 77030 | United States |
| Teva Investigational Site 14905 | McKinney | Texas | 75069 | United States |
| Teva Investigational Site 14879 | San Antonio | Texas | 78229 | United States |
| Teva Investigational Site 14920 | Spokane | Washington | 99204 | United States |
| Teva Investigational Site 14881 | Greenfield | Wisconsin | 53228 | United States |
| Teva Investigational Site 59159 | Kozloduy | 999999 | Bulgaria |
| Teva Investigational Site 59166 | Montana | 3400 | Bulgaria |
| Teva Investigational Site 59163 | Plovdiv | 4002 | Bulgaria |
| Teva Investigational Site 59189 | Plovdiv | 4003 | Bulgaria |
| Teva Investigational Site 59190 | Plovdiv | 4003 | Bulgaria |
| Teva Investigational Site 59164 | Rousse | 7002 | Bulgaria |
| Teva Investigational Site 59168 | Sofia | 1000 | Bulgaria |
| Teva Investigational Site 59167 | Sofia | 1606 | Bulgaria |
| Teva Investigational Site 59160 | Stara Zagora | 6001 | Bulgaria |
| Teva Investigational Site 59161 | Stara Zagora | 999999 | Bulgaria |
| Teva Investigational Site 59165 | Varna | 9020 | Bulgaria |
| Teva Investigational Site 59162 | Veliko Tarnovo | 5000 | Bulgaria |
| Teva Investigational Site 59192 | Vratsa | 3001 | Bulgaria |
| Teva Investigational Site 54197 | Brandýs nad Labem | 25001 | Czechia |
| Teva Investigational Site 54194 | Jindřichův Hradec | 999999 | Czechia |
| Teva Investigational Site 54193 | Miroslav | 671 721 | Czechia |
| Teva Investigational Site 54195 | Prague | 182 00 | Czechia |
| Teva Investigational Site 54203 | Strakonice | 999999 | Czechia |
| Teva Investigational Site 54196 | Teplice | 415 01 | Czechia |
| Teva Investigational Site 32747 | Berlin | 10787 | Germany |
| Teva Investigational Site 32759 | Frankfurt am Main | 60389 | Germany |
| Teva Investigational Site 32741 | Frankfurt am Main | 60596 | Germany |
| Teva Investigational Site 32744 | Geesthacht | 21502 | Germany |
| Teva Investigational Site 32739 | Hamburg | 22299 | Germany |
| Teva Investigational Site 32746 | Hanover | 30173 | Germany |
| Teva Investigational Site 32757 | Leipzig | 04537 | Germany |
| Teva Investigational Site 32758 | Leipzig | 4157 | Germany |
| Teva Investigational Site 32756 | Leipzig | ?04275 | Germany |
| Teva Investigational Site 32742 | Lübeck | 23552 | Germany |
| Teva Investigational Site 32743 | München | 81241 | Germany |
| Teva Investigational Site 32745 | Rheine | 48431 | Germany |
| Teva Investigational Site 53461 | Bydgoszcz | 85-231 | Poland |
| Teva Investigational Site 53458 | Krakaw | 31-033 | Poland |
| Teva Investigational Site 53457 | Krakow | 31-559 | Poland |
| Teva Investigational Site 53455 | Lodz | 90-302 | Poland |
| Teva Investigational Site 53483 | Poznan | 60 - 823 | Poland |
| Teva Investigational Site 53459 | Poznan | 60-214 | Poland |
| Teva Investigational Site 53486 | Sucha Beskidzka | 34200 | Poland |
| Teva Investigational Site 53462 | Tarnów | 33-100 | Poland |
| Teva Investigational Site 53485 | Warsaw | 01-868 | Poland |
| Teva Investigational Site 53460 | Wroclaw | 53-201 | Poland |
| Teva Investigational Site 53456 | Wroclaw | 53-301 | Poland |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent-to-treat (ITT) analysis set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to TEV-48574 SC every 2 weeks for a total of 8 doses. |
| BG001 | TEV-48574 | Participants received TEV-48574 loading dose SC on the day of randomization and the subsequent corresponding TEV-48574 maintenance doses SC every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period | The LoAC was defined as any 1 of the following during the treatment period: - morning peak expiratory flow (PEF) decrease ≥30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second of exhalation (FEV1) decrease ≥20% from baseline on 2 consecutive days; - increase in short-acting beta-agonist (SABA)/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in inhaled corticosteroids (ICS) dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma emergency room (ER) visit or hospitalization. | The ITT analysis set included all randomized participants. | Posted | Count of Participants | Participants | From randomization (Week 0) until Week 16 |
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| Secondary | Time From Randomization to LoAC During the Treatment Period | Time (in days) from randomization to LoAC during the treatment period is the interval from randomization to the occurrence of the LoAC. The LoAC was defined as any 1 of the following during the treatment period: - morning PEF decrease ≥30% from baseline on 2 consecutive days or morning handheld FEV1 decrease ≥20% from baseline on 2 consecutive days; - increase in SABA/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in ICS dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma ER visit or hospitalization. | The ITT analysis set included all randomized participants. | Posted | Median | 95% Confidence Interval | days | From randomization (Week 0) until Week 16 |
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| Secondary | Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16 | The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. | The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16 | FEV1 (measured by handheld spirometer) is the volume of air that can be forcibly exhaled from the lungs in the first second. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. | The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | %predicted FEV1 | Baseline, Week 16 |
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| Secondary | Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16 | Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily. | The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | puffs of SABA/day | Baseline, Week 16 |
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| Secondary | Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period | The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma. Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer). | The ITT analysis set included all randomized participants. | Posted | Count of Participants | Participants | From randomization (Week 0) until Week 16 |
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| Secondary | Time From Randomization to First CAE During the Treatment Period for Participants With CAE | The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma. Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer). | The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Median | Full Range | days | From randomization (Week 0) until Week 16 |
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| Secondary | Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16 | Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning. | The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | nighttime awakenings | Baseline, Week 16 |
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| Secondary | Percent Change in ICS Dose During the Treatment Period | The ICS dose was not collected in the participant diary as planned. | Due to change in planned analysis, no data was collected to evaluate this outcome measure. | Posted | From randomization (Week 0) until Week 16 |
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| Secondary | Change From Baseline in Forced Vital Capacity (FVC) at Week 16 | FVC (measured by handheld spirometer) is the volume of air that can be forcibly and completely blown out after full inspiration, measured in liters. | The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | liters | Baseline, Week 16 |
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| Secondary | Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16 | The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC | The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | liters/second | Baseline, Week 16 |
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| Secondary | Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16 | FeNO was performed prior to the on-site spirometry. | The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | parts per billion (ppb) | Baseline, Week 16 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered treatment emergent (TEAEs) if onset occurred on or after the first dose date. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. AEs include clinically significant changes from baseline in any one of the following categories: clinical laboratory test results, vital signs, ECG findings. | Safety analysis set included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From randomization (Week 0) until Week 24 |
|
From randomization (Week 0) until Week 24
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to TEV-48574 SC every 2 weeks for a total of 8 doses. | 0 | 31 | 1 | 31 | 4 | 31 |
| EG001 | TEV-48574 | Participants received TEV-48574 loading dose SC on the day of randomization and the subsequent corresponding TEV-48574 maintenance doses SC every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses). | 0 | 33 | 1 | 33 | 6 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 888-483-8279 | USMedInfo@tevapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2021 | Dec 15, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Other |
|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
|
|
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|