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A Study to Test if TEV-53275 is Effective in Relieving Asthma

Primary Purpose

Asthma

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

TEV-53275 Dose A

TEV-53275 Dose B

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Persistent, Eosinophilic, Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The participant is an adult female or male ≥18 years of age. Note: Age requirements are as specified or allowed by local regulations.
The participant has a diagnosis of asthma for at least 6 months and has been stable without exacerbation or change in medications for at least 1 month..
Current Asthma Therapy: The participant has been maintained for at least 1 month on stable doses of:
- medium or high dose inhaled corticosteroids (ICS)±another controller.
- any fixed dose combination ICS (low, medium, or high) with long-acting beta agonist (LABA)±another controller.
Women of non-childbearing potential, or congenitally sterile, or 1-year postmenopausal. Women of childbearing potential must have a negative β-human chorionic gonadotropin (β-HCG) test result and practice a highly effective method of birth control prior to investigational medicinal product (IMP) administration and 30 weeks after the dose of IMP.
The participant, as judged by the investigator, is able to continue their current asthma maintenance medications throughout the study.

NOTE- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

Life threatening asthma, defined as a history of asthma episode(s) requiring intubation and/or associated hypercapnea, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
The participant has a suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period. Note: Participants who develop an upper respiratory infection/lower respiratory infection (URI/LRI) during the run-in period may rescreen 2 weeks after symptoms resolve and undergo coronavirus disease 2019 (COVID-19) testing.
Participants with a confirmed infection with COVID-19 within 3 months prior to the screening visit.
The participant has an eosinophilic condition including hypereosinophilic syndrome, eosinophilic pneumonia, eosinophilic granulomatosis with polyangiitis (EGPA [Churg Strauss syndrome]), or allergic bronchopulmonary aspergillosis.
The participant has an active helminthic or parasitic infection currently or within the last 6 months.
The participant has a history of malignancy other than fully resected basal cell carcinoma of the skin.
The participant has any clinically significant, uncontrolled medical or psychiatric condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the participant's safety.
The participant has known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies (Ab), or human immunodeficiency virus (HIV) Types 1 or 2 Ab (according to 4th generation serology testing).
The participant is a pregnant or lactating woman, or plans to become pregnant during the study.
The participant has previously participated in a study with TEV-53275.
The participant has participated in another study of an IMP (or a medical device) within the previous 30 days or is currently participating in another study of an IMP (or a medical device).
The participant has been treated with a monoclonal antibody used to treat asthma or other inflammatory conditions within the washout period (5 half-lives), has demonstrated hypersensitivity or anaphylaxis to a monoclonal antibody (Appendix G),or is currently using or has used a systemic immunosuppressive medication within the last 6 months. NOTE: Prior depemokimab exposure is prohibited without exception.
The participant has a history of chronic alcohol or drug abuse within the previous 2 years.
The participant currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes [20 cigarettes]/day for 1 year), OR the participant used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco), OR the patient has smoked marijuana within 1 month, OR the participant has a history of "vaping" tobacco, marijuana, or any other substance within 24 months.
Vulnerable participants (eg, people kept in detention).

NOTE- Additional criteria apply, please contact the investigator for more information

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

TEV-53275 Dose A

TEV-53275 Dose B

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 12

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Least square (LS) mean and standard error (SE) were calculated using a mixed model for repeated measures (MMRM).

Secondary Outcome Measures

Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16

The weekly asthma control status (Yes or No) is the derived asthma control composite score based on the following criteria: 1. Two or more of the following criteria were fulfilled: ≤2 days with a daily asthma symptom score >1; - ≤2 days of albuterol/salbutamol used as rescue medication up to a maximum of 4 occasions per week (multiple occasions per day are counted as separate occasions); - morning FEV1 ≥80% predicted for each day (by handheld device) and 2. Both of the following criteria were fulfilled: no night-time awakenings due to asthma; - no use of asthma maintenance medications. The asthma control status in each weekly analysis window was Yes if the conditions 1 and 2 above were met, No otherwise.

Change From Baseline in the Weekly Average of Daily Morning Trough (Pre-Rescue Bronchodilator) FEV1 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by a handheld device. The post-baseline analysis window for over 12 weeks was from the first day of study drug up to Day 84. The post-baseline analysis window for over 16 weeks was from the first day of study drug up to Day 112. The daily average of the efficacy data with each weekly analysis window was calculated based on non-missing e-diary as follow: Summation of FEV1 during an analysis window/Number of days with nonmissing data in the analysis window. LS mean and SE was calculated using an MMRM.

Change From Baseline in Weekly Average of Rescue Medication Use Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16

The number of times asthma rescue medication (number of inhalations/puffs) was used was assessed (for example, by reviewing the electronic diary or if required due to missing data in the diary, by site tracking of the inhalation counter on the inhaler). Rescue medication included albuterol sulfate inhalation powder (albuterol eMDPI) or equivalent albuterol/salbutamol. The post-baseline analysis window for over 12 weeks was from the first day of study drug up to Day 84. The post-baseline analysis window for over 16 weeks was from the first day of study drug up to Day 112. The daily average of the efficacy data with each weekly analysis window was calculated based on non-missing e-diary as follow: Summation of rescue medication uses during an analysis window/Number of days with nonmissing data in the analysis window. LS mean and SE were calculated using Wilcoxon rank-sum test stratified on randomization stratification factors.

Change From Baseline in Weekly Percentage of Asthma Control Days (No Symptoms and No Rescue Medication Use) Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16

An asthma control day was defined as a day on which the participant used 0 puffs of inhaled short-acting β-adrenergic agonist (SABA), had no night-time awakenings, and experienced no asthma exacerbations. The post-baseline analysis window for over 12 weeks was from the first day of study drug up to Day 84. The post-baseline analysis window for over 16 weeks was from the first day of study drug up to Day 112. Percentage of asthma control days in each analysis window was calculated as follow: Summation of asthma control days in an analysis window/Number of days with nonmissing data in the analysis window * 100.

Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 16

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. LS mean and SE were calculated using an MMRM.

Number of Participants Who Achieved Clinic-based FEV1 ≥80% Predicted at Weeks 12 and 16

The percent of predicted FEV1 (the volume of air exhaled in the first second of a forced expiration) was measured by handheld device.

Number of Participants Who Achieved Forced Expiratory Flow at 25% to 75% of Forced Expiratory Volume (FVC) (FEF25-75) ≥70% Predicted at Weeks 12 and 16

The FVC is the volume of air that can be forcibly blown out after full inspiration. FVC results in this study were presented as the forced expiratory flow at 25% to 75% of FVC.

Change From Baseline in FEF25-75 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16

The FVC is the volume of air that can be forcibly blown out after full inspiration. FVC results in this study were presented as the forced expiratory flow at 25% to 75% of FVC. The post-baseline analysis window for over 12 weeks was from the first day of study drug up to Day 84. The post-baseline analysis window for over 16 weeks was from the first day of study drug up to Day 112. The daily average of the efficacy data with each weekly analysis window was calculated based on non-missing e-diary as follow: Summation of FEF25-75 during an analysis window/Number of days with nonmissing data in the analysis window. LS mean and SE were calculated using an MMRM.

Time to First Clinical Asthma Exacerbation (CAE)

The time (days) to the first CAE was the interval from the randomization to the occurrence of the first CAE. A CAE was defined as worsening asthma requiring treatment with a systemic corticosteroid for at least 3 days, emergency room visit resulting in systemic corticosteroid treatment, or 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 electronic diary/handheld spirometer) and required the addition of maintenance medications (other than systemic corticosteroids) to control the participant's asthma symptoms based on the investigator's judgment.

Change From Baseline in Asthma Control Questionnaire (ACQ-6) Score at Weeks 12 and 16

The ACQ-6 is a validated 6-item 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 has a possible score ranging from 0 (no impairment) to 6 (maximum impairment), and the total score is the mean of all responses. The total score ranging from 0 (totally controlled) to 6 (severely uncontrolled) with higher scores indicating maximum impairment.

Change From Baseline in Asthma Control Test (ACT) Score at Weeks 12 and 16

The Asthma Control Test (ACT) is a participant self-administered tool for identifying those with poorly controlled asthma comprising 5 items, with 4-week recall (on symptoms and daily functioning). It assesses the frequency of shortness of breath and general asthma symptoms, the use of rescue medications, the effect of asthma on daily functioning, and the overall self-assessment of asthma control measured on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). Total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.

Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Weeks 12 and 16

The AQLQ[S] (participants ≥18 years of age version) was self-administered by participants. The questionnaire is a tool to measure the impact of asthma on a participant's quality of life (physical, emotional, social, and occupational). The aim of the questionnaire is to evaluate the problems that were most troublesome to participants in their day to day lives. The questionnaire contains 32 items with a 2-week recall period and used a 7-point Likert scale (7=not impaired at all to 1=severely impaired). The overall AQLQ score was the mean of the responses to each of the 32 questions and ranged from 1 (severely impaired) to 7 (not impaired at all) with higher scores indicating better quality of life.

Number of Participants Who Achieved FEV1:FVC Ratio ≥0.80 at Weeks 12 and 16

FEV1 was the volume of air exhaled in the first second of a forced expiration. FVC is the volume of air that can be forcibly blown out after full inspiration.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through the end of the study. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Number of Participants Who Received at Least 1 Concomitant Asthma Medication

Concomitant asthma medications included Antihistamines for systemic use (Cetirizine); Corticosteroids for systemic use (Prednisone, Methylprednisolone); and Drugs for obstructive airway diseases (Salbutamol, Fluticasone etc.).

Number of Participants Developing Antidrug Antibodies (ADAs) Throughout the Study

A participant was classified as having a treatment-emergent ADA response if either of the following were true: - The participant had a positive sample at any of the postdose time points, but not at the predose (baseline) time point; - The participant had a positive sample at predose (baseline) and 1 or more postdose time points, but the titer of a postdose sample(s) was increased by at least 4-fold when comparing it to that of the predose sample.

Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Value

Potentially clinically significant serum chemistry abnormalities included: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase, Gamma-glutamyl transpeptidase (GGT), Lactate dehydrogenase (LDH), and Creatinine phosphokinase each ≥3 * upper limit of normal (ULN); Blood urea nitrogen ≥10.71 millimoles (mmol)/liter (L); Creatinine ≥177 micromoles (μmol)/L; and Bilirubin (total) ≥34.2 μmol /L.

Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value

Potentially clinically significant hematological abnormalities included: White blood cells (WBCs) count ≤3.0 *10^9 cells/L or ≥20 * 10^9 cells/L; Hemoglobin ≤95 grams (g)/L in females and ≤115 g/L in males; Hematocrit <0.32 L/L in females and <0.37 L/L in males; Platelet count ≤75 * 10^9 cells/L or ≥700 * 10^9 cells/L; and Absolute neutrophil count (ANC) ≤1 * 10^9 cells/L.

Number of Participants With at Least 1 Potentially Clinically Significant Urinalysis Abnormalities

Potentially clinically significant urinalysis abnormalities included: ≥2 unit increase from baseline in urine hemoglobin, ketones, glucose, and total protein.

Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value

Potentially clinically significant vital signs abnormalities included: Systolic blood pressure (BP): ≤90 millimeters of mercury (mmHg) and decrease from baseline of 20 mm Hg or ≥180 mm Hg and increase from baseline of ≥20 mm Hg; Diastolic BP: ≥105 mmHg and increase from baseline of ≥15 mmHg or ≤50 mmHg and decrease from baseline of ≥15 mmHg; Pulse ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm or ≤50 bpm and decrease from baseline of ≥15 bpm; Temperature ≥38.3 degrees celsius (ºC) and change from baseline of ≥1.1 ºC; Respiratory rate >24 breaths/min and increase from baseline of ≥10 breaths/min.

Number of Participants With Potentially Clinically Significant Abnormal Electrocardiogram Values

Potentially clinically significant electrocardiogram abnormalities including any one of the following values: QTc interval >450 milliseconds (msec) and QTc interval increases from baseline >30 msec, QTc interval >450 msec and QTc interval increases from baseline >60 msec, QTc interval >500 msec and QTc interval increases from baseline >30 msec, QTc interval >500 msec and QTc interval increases from baseline >60 msec; QRS duration >110 msec and a 25% increase from baseline; and PR interval >200 msec and a 25% increase from baseline.

Number of Participants With Injection Site Reactions

Injection site reactions included erythema, ecchymosis, induration, tenderness, warmth, and swelling. Number of participants with erythema, ecchymosis, and induration were reported in following categories: Absent; 5 millimeters (mm) to ≤50 mm (mild); >50 mm to ≤100 mm (moderate); and >100 mm (severe). Number of participants with tenderness, warmth, and swelling were reported in following categories: Absent; mild; moderate; and severe.

Number of Participants Who Did Not Complete the Study Due to AEs

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who did not complete the study due to AEs were reported.

Full Information

NCT ID

NCT04847674

First Posted

April 5, 2021

Last Updated

May 12, 2023

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04847674

Brief Title

A Study to Test if TEV-53275 is Effective in Relieving Asthma

Official Title

A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety, Efficacy and Pharmacodynamics of TEV 53275 Administered Subcutaneously in Adult Patients With Persistent Eosinophilic Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Stopped for strategic reasons

Study Start Date

May 4, 2021 (Actual)

Primary Completion Date

April 28, 2022 (Actual)

Study Completion Date

April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of the study is to evaluate the efficacy of TEV-53275 administered subcutaneously (sc) in adult participants with persistent asthma and an eosinophilic phenotype compared to placebo. A secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication use, and quality of life measures. Another secondary objective is to evaluate the safety and tolerability of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype compared with placebo, and lastly, to evaluate the immunogenicity of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype.

Detailed Description

The planned study duration is approximately 16 months. The total duration of study participation is approximately 34 weeks including up to a 2-week screening period, a 2-week run-in period, a 16-week treatment period, and a follow-up visit 14 weeks after the final treatment visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Persistent, Eosinophilic, Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TEV-53275 Dose A

Arm Type

Experimental

Arm Title

TEV-53275 Dose B

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

TEV-53275 Dose A

Intervention Description

subcutaneous (sc) injection

Intervention Type

Drug

Intervention Name(s)

TEV-53275 Dose B

Intervention Description

subcutaneous (sc) injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching subcutaneous (sc) placebo injection

Primary Outcome Measure Information:

Title

Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16

Description

Time Frame

Weeks 12 and 16

Title

Change From Baseline in the Weekly Average of Daily Morning Trough (Pre-Rescue Bronchodilator) FEV1 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16

Description

Time Frame

Baseline, up to Week 12, up to Week 16

Title

Change From Baseline in Weekly Average of Rescue Medication Use Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16

Description

Time Frame

Baseline, up to Week 12, up to Week 16

Title

Change From Baseline in Weekly Percentage of Asthma Control Days (No Symptoms and No Rescue Medication Use) Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16

Description

Time Frame

Baseline, up to Week 12, up to Week 16

Title

Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 16

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. LS mean and SE were calculated using an MMRM.

Time Frame

Baseline, Week 16

Title

Number of Participants Who Achieved Clinic-based FEV1 ≥80% Predicted at Weeks 12 and 16

Description

The percent of predicted FEV1 (the volume of air exhaled in the first second of a forced expiration) was measured by handheld device.

Time Frame

Weeks 12 and 16

Title

Number of Participants Who Achieved Forced Expiratory Flow at 25% to 75% of Forced Expiratory Volume (FVC) (FEF25-75) ≥70% Predicted at Weeks 12 and 16

Description

The FVC is the volume of air that can be forcibly blown out after full inspiration. FVC results in this study were presented as the forced expiratory flow at 25% to 75% of FVC.

Time Frame

Weeks 12 and 16

Title

Change From Baseline in FEF25-75 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16

Description

Time Frame

Baseline, up to Week 12, up to Week 16

Title

Time to First Clinical Asthma Exacerbation (CAE)

Description

Time Frame

Baseline up to Week 16

Title

Change From Baseline in Asthma Control Questionnaire (ACQ-6) Score at Weeks 12 and 16

Description

Time Frame

Baseline, Week 12, Week 16

Title

Change From Baseline in Asthma Control Test (ACT) Score at Weeks 12 and 16

Description

Time Frame

Baseline, Week 12, Week 16

Title

Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Weeks 12 and 16

Description

Time Frame

Baseline, Week 12, Week 16

Title

Number of Participants Who Achieved FEV1:FVC Ratio ≥0.80 at Weeks 12 and 16

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration. FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

Weeks 12 and 16

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Baseline up to Week 30

Title

Number of Participants Who Received at Least 1 Concomitant Asthma Medication

Description

Time Frame

Baseline up to Week 30

Title

Number of Participants Developing Antidrug Antibodies (ADAs) Throughout the Study

Description

Time Frame

Baseline up to Week 30

Title

Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Value

Description

Time Frame

Baseline up to Week 30

Title

Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value

Description

Time Frame

Baseline up to Week 30

Title

Number of Participants With at Least 1 Potentially Clinically Significant Urinalysis Abnormalities

Description

Potentially clinically significant urinalysis abnormalities included: ≥2 unit increase from baseline in urine hemoglobin, ketones, glucose, and total protein.

Time Frame

Baseline up to Week 30

Title

Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value

Description

Time Frame

Baseline up to Week 30

Title

Number of Participants With Potentially Clinically Significant Abnormal Electrocardiogram Values

Description

Time Frame

Baseline up to Week 30

Title

Number of Participants With Injection Site Reactions

Description

Time Frame

Baseline up to Week 30

Title

Number of Participants Who Did Not Complete the Study Due to AEs

Description

Time Frame

Baseline up to Week 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant is an adult female or male ≥18 years of age. Note: Age requirements are as specified or allowed by local regulations. The participant has a diagnosis of asthma for at least 6 months and has been stable without exacerbation or change in medications for at least 1 month.. Current Asthma Therapy: The participant has been maintained for at least 1 month on stable doses of: medium or high dose inhaled corticosteroids (ICS)±another controller. any fixed dose combination ICS (low, medium, or high) with long-acting beta agonist (LABA)±another controller. Women of non-childbearing potential, or congenitally sterile, or 1-year postmenopausal. Women of childbearing potential must have a negative β-human chorionic gonadotropin (β-HCG) test result and practice a highly effective method of birth control prior to investigational medicinal product (IMP) administration and 30 weeks after the dose of IMP. The participant, as judged by the investigator, is able to continue their current asthma maintenance medications throughout the study. NOTE- Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: Life threatening asthma, defined as a history of asthma episode(s) requiring intubation and/or associated hypercapnea, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s). The participant has a suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period. Note: Participants who develop an upper respiratory infection/lower respiratory infection (URI/LRI) during the run-in period may rescreen 2 weeks after symptoms resolve and undergo coronavirus disease 2019 (COVID-19) testing. Participants with a confirmed infection with COVID-19 within 3 months prior to the screening visit. The participant has an eosinophilic condition including hypereosinophilic syndrome, eosinophilic pneumonia, eosinophilic granulomatosis with polyangiitis (EGPA [Churg Strauss syndrome]), or allergic bronchopulmonary aspergillosis. The participant has an active helminthic or parasitic infection currently or within the last 6 months. The participant has a history of malignancy other than fully resected basal cell carcinoma of the skin. The participant has any clinically significant, uncontrolled medical or psychiatric condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the participant's safety. The participant has known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies (Ab), or human immunodeficiency virus (HIV) Types 1 or 2 Ab (according to 4th generation serology testing). The participant is a pregnant or lactating woman, or plans to become pregnant during the study. The participant has previously participated in a study with TEV-53275. The participant has participated in another study of an IMP (or a medical device) within the previous 30 days or is currently participating in another study of an IMP (or a medical device). The participant has been treated with a monoclonal antibody used to treat asthma or other inflammatory conditions within the washout period (5 half-lives), has demonstrated hypersensitivity or anaphylaxis to a monoclonal antibody (Appendix G),or is currently using or has used a systemic immunosuppressive medication within the last 6 months. NOTE: Prior depemokimab exposure is prohibited without exception. The participant has a history of chronic alcohol or drug abuse within the previous 2 years. The participant currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes [20 cigarettes]/day for 1 year), OR the participant used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco), OR the participant has smoked marijuana within 1 month, OR the participant has a history of "vaping" tobacco, marijuana, or any other substance within 24 months. Vulnerable participants (eg, people kept in detention). NOTE- Additional criteria apply, please contact the investigator for more information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 15188

City

Hoover

State/Province

Alabama

ZIP/Postal Code

35244

Country

United States

Facility Name

Teva Investigational Site 15174

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Teva Investigational Site 15202

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85031

Country

United States

Facility Name

Teva Investigational Site 15205

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Teva Investigational Site 15178

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Teva Investigational Site 15196

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Teva Investigational Site 15176

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Teva Investigational Site 15156

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647 6818

Country

United States

Facility Name

Teva Investigational Site 15209

City

Inglewood

State/Province

California

ZIP/Postal Code

90303

Country

United States

Facility Name

Teva Investigational Site 15194

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Teva Investigational Site 15143

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Teva Investigational Site 15212

City

Los Angeles

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Teva Investigational Site 15151

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Teva Investigational Site 15210

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Teva Investigational Site 15136

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Teva Investigational Site 15157

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Teva Investigational Site 15158

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Teva Investigational Site 15167

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Teva Investigational Site 15133

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Teva Investigational Site 15166

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Teva Investigational Site 15200

City

Lafayette

State/Province

Colorado

ZIP/Postal Code

80026

Country

United States

Facility Name

Teva Investigational Site 15139

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Teva Investigational Site 15182

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33435

Country

United States

Facility Name

Teva Investigational Site 15147

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Teva Investigational Site 15134

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Teva Investigational Site 15152

City

Leesburg

State/Province

Florida

ZIP/Postal Code

34748

Country

United States

Facility Name

Teva Investigational Site 15169

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Teva Investigational Site 15149

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Teva Investigational Site 15211

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Teva Investigational Site 15206

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Teva Investigational Site 15215

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Teva Investigational Site 15141

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Teva Investigational Site 15170

City

North Palm Beach

State/Province

Florida

ZIP/Postal Code

33408

Country

United States

Facility Name

Teva Investigational Site 15130

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Teva Investigational Site 15140

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308-4355

Country

United States

Facility Name

Teva Investigational Site 15132

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Teva Investigational Site 15135

City

Sugar Hill

State/Province

Georgia

ZIP/Postal Code

30518

Country

United States

Facility Name

Teva Investigational Site 15183

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Teva Investigational Site 15198

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Teva Investigational Site 15187

City

Zachary

State/Province

Louisiana

ZIP/Postal Code

70791

Country

United States

Facility Name

Teva Investigational Site 15148

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21236

Country

United States

Facility Name

Teva Investigational Site 15190

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Teva Investigational Site 15175

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65203

Country

United States

Facility Name

Teva Investigational Site 15145

City

Rolla

State/Province

Missouri

ZIP/Postal Code

65401

Country

United States

Facility Name

Teva Investigational Site 15144

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Teva Investigational Site 15137

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68123-4303

Country

United States

Facility Name

Teva Investigational Site 15164

City

Skillman

State/Province

New Jersey

ZIP/Postal Code

08558

Country

United States

Facility Name

Teva Investigational Site 15165

City

Bronx

State/Province

New York

ZIP/Postal Code

10455

Country

United States

Facility Name

Teva Investigational Site 15181

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Teva Investigational Site 15179

City

Elizabeth City

State/Province

North Carolina

ZIP/Postal Code

27909

Country

United States

Facility Name

Teva Investigational Site 15193

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27410

Country

United States

Facility Name

Teva Investigational Site 15153

City

Monroe

State/Province

North Carolina

ZIP/Postal Code

28112

Country

United States

Facility Name

Teva Investigational Site 15168

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Teva Investigational Site 15173

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Teva Investigational Site 15131

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Facility Name

Teva Investigational Site 15201

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Teva Investigational Site 15204

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74133

Country

United States

Facility Name

Teva Investigational Site 15180

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Teva Investigational Site 15172

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Teva Investigational Site 15192

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Teva Investigational Site 15185

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Teva Investigational Site 15161

City

Clinton

State/Province

South Carolina

ZIP/Postal Code

29325

Country

United States

Facility Name

Teva Investigational Site 15159

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Teva Investigational Site 15162

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Teva Investigational Site 15138

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Teva Investigational Site 15154

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Teva Investigational Site 15171

City

Denton

State/Province

Texas

ZIP/Postal Code

76210

Country

United States

Facility Name

Teva Investigational Site 15155

City

El Paso

State/Province

Texas

ZIP/Postal Code

79903-3508

Country

United States

Facility Name

Teva Investigational Site 15189

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Teva Investigational Site 15184

City

Houston

State/Province

Texas

ZIP/Postal Code

77070

Country

United States

Facility Name

Teva Investigational Site 15199

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

Teva Investigational Site 15191

City

Houston

State/Province

Texas

ZIP/Postal Code

77087

Country

United States

Facility Name

Teva Investigational Site 15160

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Teva Investigational Site 15197

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Teva Investigational Site 15195

City

Williamsburg

State/Province

Virginia

ZIP/Postal Code

23188

Country

United States

Facility Name

Teva Investigational Site 15150

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

Facility Name

Teva Investigational Site 15142

City

Greenfield

State/Province

Wisconsin

ZIP/Postal Code

53228

Country

United States

Facility Name

Teva Investigational Site 11218

City

Sherwood Park

State/Province

Alberta

ZIP/Postal Code

T8H 0N2

Country

Canada

Facility Name

Teva Investigational Site 11212

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 2J5

Country

Canada

Facility Name

Teva Investigational Site 11211

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Teva Investigational Site 11213

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1L5

Country

Canada

Facility Name

Teva Investigational Site 11214

City

Quebec

ZIP/Postal Code

G1V4W2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

A Study to Test if TEV-53275 is Effective in Relieving Asthma

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A Study to Test if TEV-53275 is Effective in Relieving Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial