18 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 12Primary· Baseline, 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).
Group
Value
95% CI
Placebo
0.152
± 0.0746
TEV-53275 Dose A
0.125
± 0.0724
TEV-53275 Dose B
0.140
± 0.0718
Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16Secondary· 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.
Well-controlled asthma status at Week 12
Group
Value
95% CI
Placebo
6
TEV-53275 Dose A
11
TEV-53275 Dose B
6
Placebo
17
TEV-53275 Dose A
15
TEV-53275 Dose B
21
Well-controlled asthma status at Week 16
Group
Value
95% CI
Placebo
6
TEV-53275 Dose A
12
TEV-53275 Dose B
6
Placebo
17
TEV-53275 Dose A
12
TEV-53275 Dose B
20
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 16Secondary· Baseline, up to Week 12, up to Week 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 over 12 weeks
Group
Value
95% CI
Placebo
0.007
± 0.0373
TEV-53275 Dose A
0.034
± 0.0365
TEV-53275 Dose B
0.034
± 0.0362
Change over 16 weeks
Group
Value
95% CI
Placebo
0.009
± 0.0378
TEV-53275 Dose A
0.036
± 0.0369
TEV-53275 Dose B
0.032
± 0.0367
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 16Secondary· Baseline, up to Week 12, up to Week 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 t
Change in weekly average rescue medication use over 12 weeks
Group
Value
95% CI
Placebo
-3.7
± 9.21
TEV-53275 Dose A
-3.4
± 5.86
TEV-53275 Dose B
-2.9
± 8.55
Change in weekly average rescue medication use over 16 weeks
Group
Value
95% CI
Placebo
-4.2
± 9.30
TEV-53275 Dose A
-3.5
± 5.81
TEV-53275 Dose B
-3.0
± 8.66
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 16Secondary· Baseline, up to Week 12, up to Week 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 analys
Change in weekly percentage of asthma control days over 12 weeks
Group
Value
95% CI
Placebo
23.21
± 36.645
TEV-53275 Dose A
21.51
± 23.907
TEV-53275 Dose B
12.71
± 27.024
Change in weekly percentage of asthma control days over 16 weeks
Group
Value
95% CI
Placebo
24.28
± 36.557
TEV-53275 Dose A
23.23
± 25.585
TEV-53275 Dose B
13.57
± 28.148
Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 16Secondary· Baseline, 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.
Group
Value
95% CI
Placebo
0.175
± 0.0787
TEV-53275 Dose A
0.092
± 0.0771
TEV-53275 Dose B
0.086
± 0.0754
Number of Participants Who Achieved Clinic-based FEV1 ≥80% Predicted at Weeks 12 and 16Secondary· 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.
Week 12
Group
Value
95% CI
Placebo
7
TEV-53275 Dose A
7
TEV-53275 Dose B
8
Week 16
Group
Value
95% CI
Placebo
6
TEV-53275 Dose A
4
TEV-53275 Dose B
5
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 16Secondary· 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.
Week 12
Group
Value
95% CI
Placebo
2
TEV-53275 Dose A
3
TEV-53275 Dose B
1
Week 16
Group
Value
95% CI
Placebo
2
TEV-53275 Dose A
2
TEV-53275 Dose B
2
Change From Baseline in FEF25-75 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16Secondary· Baseline, up to Week 12, up to Week 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 th
Change in FEF25-75 over 12 weeks
Group
Value
95% CI
Placebo
0.086
± 0.0742
TEV-53275 Dose A
0.179
± 0.0734
TEV-53275 Dose B
0.119
± 0.0721
Change in FEF25-75 over 16 weeks
Group
Value
95% CI
Placebo
0.098
± 0.0772
TEV-53275 Dose A
0.185
± 0.0763
TEV-53275 Dose B
0.108
± 0.0749
Time to First Clinical Asthma Exacerbation (CAE)Secondary· Baseline up to Week 16
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
Group
Value
95% CI
Placebo
54.5
± 36.06
TEV-53275 Dose A
77.0
± 47.82
TEV-53275 Dose B
87.0
± 36.77
Change From Baseline in Asthma Control Questionnaire (ACQ-6) Score at Weeks 12 and 16Secondary· Baseline, Week 12, Week 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
Change in ACQ-6 score at Week 12
Group
Value
95% CI
Placebo
-1.1
± 0.16
TEV-53275 Dose A
-1.1
± 0.16
TEV-53275 Dose B
-1.0
± 0.15
Change in ACQ-6 score at Week 16
Group
Value
95% CI
Placebo
-1.0
± 0.16
TEV-53275 Dose A
-1.1
± 0.16
TEV-53275 Dose B
-1.0
± 0.16
Change From Baseline in Asthma Control Test (ACT) Score at Weeks 12 and 16Secondary· Baseline, Week 12, Week 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 (po
Change at Week 12
Group
Value
95% CI
Placebo
4.8
± 0.75
TEV-53275 Dose A
4.1
± 0.73
TEV-53275 Dose B
3.6
± 0.70
Change at Week 16
Group
Value
95% CI
Placebo
4.6
± 0.72
TEV-53275 Dose A
4.0
± 0.71
TEV-53275 Dose B
3.7
± 0.68
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Week 30.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 0/31 (0%)
Deaths: 0/31
TEV-53275 Dose A
Serious: 2/34 (6%)
Deaths: 0/34
TEV-53275 Dose B
Serious: 1/31 (3%)
Deaths: 0/31
Serious adverse events (3 terms)
Reaction
System
Placebo
TEV-53275 Dose A
TEV-53275 Dose B
Diverticulitis
Infections and infestations
—
—
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
—
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D, Inc.
Last refreshed: 8 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04847674.