Trial Outcomes & Findings for A Study to Test if TEV-53275 is Effective in Relieving Asthma (NCT NCT04847674)

NCT ID: NCT04847674

Last Updated: 2023-06-08

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 97 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2023-06-08

Participant Flow

Participant milestones

Measure	Placebo Participants received placebo matched to TEV-53275 subcutaneously (SC) at baseline (Day 0).	TEV-53275 Dose A Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B Participants received TEV-53275 Dose B SC at baseline (Day 0).
Overall Study STARTED	32	33	32
Overall Study Received at Least 1 Dose of Study Drug as Randomized	31	33	32
Overall Study Modified Intent-to-treat (mITT) Analysis Set	31	33	32
Overall Study Safety Analysis Set	31	34	31
Overall Study COMPLETED	11	12	10
Overall Study NOT COMPLETED	21	21	22

Reasons for withdrawal

Measure	Placebo Participants received placebo matched to TEV-53275 subcutaneously (SC) at baseline (Day 0).	TEV-53275 Dose A Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B Participants received TEV-53275 Dose B SC at baseline (Day 0).
Overall Study Withdrawal by Subject	0	1	0
Overall Study Lost to Follow-up	0	0	2
Overall Study Other than specified	21	20	20

Baseline Characteristics

The mITT analysis set included all randomized participants who received at least a partial dose of study drug.

Baseline characteristics by cohort

Measure	Placebo n=32 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=33 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=32 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).	Total n=97 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 12.94 • n=32 Participants	51.2 years STANDARD_DEVIATION 13.79 • n=33 Participants	53.2 years STANDARD_DEVIATION 15.05 • n=32 Participants	51.9 years STANDARD_DEVIATION 13.83 • n=97 Participants
Sex: Female, Male Female	23 Participants n=32 Participants	18 Participants n=33 Participants	19 Participants n=32 Participants	60 Participants n=97 Participants
Sex: Female, Male Male	9 Participants n=32 Participants	15 Participants n=33 Participants	13 Participants n=32 Participants	37 Participants n=97 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=32 Participants	9 Participants n=33 Participants	5 Participants n=32 Participants	18 Participants n=97 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=32 Participants	24 Participants n=33 Participants	27 Participants n=32 Participants	79 Participants n=97 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=97 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=97 Participants
Race (NIH/OMB) Asian	1 Participants n=32 Participants	2 Participants n=33 Participants	1 Participants n=32 Participants	4 Participants n=97 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=97 Participants
Race (NIH/OMB) Black or African American	6 Participants n=32 Participants	6 Participants n=33 Participants	1 Participants n=32 Participants	13 Participants n=97 Participants
Race (NIH/OMB) White	25 Participants n=32 Participants	25 Participants n=33 Participants	29 Participants n=32 Participants	79 Participants n=97 Participants
Race (NIH/OMB) More than one race	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=97 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants	0 Participants n=33 Participants	1 Participants n=32 Participants	1 Participants n=97 Participants
Forced Expiratory Volume in 1 Second (FEV1)	1.938 liters STANDARD_DEVIATION 0.5931 • n=31 Participants • The mITT analysis set included all randomized participants who received at least a partial dose of study drug.	1.957 liters STANDARD_DEVIATION 0.6961 • n=33 Participants • The mITT analysis set included all randomized participants who received at least a partial dose of study drug.	2.064 liters STANDARD_DEVIATION 0.7411 • n=32 Participants • The mITT analysis set included all randomized participants who received at least a partial dose of study drug.	1.986 liters STANDARD_DEVIATION 0.6757 • n=96 Participants • The mITT analysis set included all randomized participants who received at least a partial dose of study drug.

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

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).

Outcome measures

Measure	Placebo n=24 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=26 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=27 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 12	0.152 liters Standard Error 0.0746	0.125 liters Standard Error 0.0724	0.140 liters Standard Error 0.0718

SECONDARY outcome

Timeframe: Weeks 12 and 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed = participants evaluable at specified timepoint.

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.

Outcome measures

Measure	Placebo n=23 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=26 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=27 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16 Well-controlled asthma status at Week 12 · No	17 Participants	15 Participants	21 Participants
Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16 Well-controlled asthma status at Week 12 · Yes	6 Participants	11 Participants	6 Participants
Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16 Well-controlled asthma status at Week 16 · Yes	6 Participants	12 Participants	6 Participants
Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16 Well-controlled asthma status at Week 16 · No	17 Participants	12 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline, up to Week 12, up to Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=33 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=32 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
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 Change over 12 weeks	0.007 liters Standard Error 0.0373	0.034 liters Standard Error 0.0365	0.034 liters Standard Error 0.0362
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 Change over 16 weeks	0.009 liters Standard Error 0.0378	0.036 liters Standard Error 0.0369	0.032 liters Standard Error 0.0367

SECONDARY outcome

Timeframe: Baseline, up to Week 12, up to Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=33 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=32 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
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 Change in weekly average rescue medication use over 12 weeks	-3.7 number of inhalations/week Standard Deviation 9.21	-3.4 number of inhalations/week Standard Deviation 5.86	-2.9 number of inhalations/week Standard Deviation 8.55
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 Change in weekly average rescue medication use over 16 weeks	-4.2 number of inhalations/week Standard Deviation 9.30	-3.5 number of inhalations/week Standard Deviation 5.81	-3.0 number of inhalations/week Standard Deviation 8.66

SECONDARY outcome

Timeframe: Baseline, up to Week 12, up to Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=33 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=32 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
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 Change in weekly percentage of asthma control days over 12 weeks	23.21 percentage of days/week Standard Deviation 36.645	21.51 percentage of days/week Standard Deviation 23.907	12.71 percentage of days/week Standard Deviation 27.024
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 Change in weekly percentage of asthma control days over 16 weeks	24.28 percentage of days/week Standard Deviation 36.557	23.23 percentage of days/week Standard Deviation 25.585	13.57 percentage of days/week Standard Deviation 28.148

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Placebo n=23 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=24 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=26 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 16	0.175 liters Standard Error 0.0787	0.092 liters Standard Error 0.0771	0.086 liters Standard Error 0.0754

SECONDARY outcome

Timeframe: Weeks 12 and 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed = participants evaluable at specified timepoint.

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

Outcome measures

Measure	Placebo n=21 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=24 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=24 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants Who Achieved Clinic-based FEV1 ≥80% Predicted at Weeks 12 and 16 Week 12	7 Participants	7 Participants	8 Participants
Number of Participants Who Achieved Clinic-based FEV1 ≥80% Predicted at Weeks 12 and 16 Week 16	6 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Weeks 12 and 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed = participants evaluable at specified timepoint.

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.

Outcome measures

Measure	Placebo n=22 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=24 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=25 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
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 Week 12	2 Participants	3 Participants	1 Participants
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 Week 16	2 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, up to Week 12, up to Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=33 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=32 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Change From Baseline in FEF25-75 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16 Change in FEF25-75 over 12 weeks	0.086 liters/second Standard Error 0.0742	0.179 liters/second Standard Error 0.0734	0.119 liters/second Standard Error 0.0721
Change From Baseline in FEF25-75 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16 Change in FEF25-75 over 16 weeks	0.098 liters/second Standard Error 0.0772	0.185 liters/second Standard Error 0.0763	0.108 liters/second Standard Error 0.0749

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Placebo n=2 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=3 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=2 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Time to First Clinical Asthma Exacerbation (CAE)	54.5 days Standard Deviation 36.06	77.0 days Standard Deviation 47.82	87.0 days Standard Deviation 36.77

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed = participants evaluable at specified timepoint.

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.

Outcome measures

Measure	Placebo n=24 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=26 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=27 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Change From Baseline in Asthma Control Questionnaire (ACQ-6) Score at Weeks 12 and 16 Change in ACQ-6 score at Week 16	-1.0 units on a scale Standard Error 0.16	-1.1 units on a scale Standard Error 0.16	-1.0 units on a scale Standard Error 0.16
Change From Baseline in Asthma Control Questionnaire (ACQ-6) Score at Weeks 12 and 16 Change in ACQ-6 score at Week 12	-1.1 units on a scale Standard Error 0.16	-1.1 units on a scale Standard Error 0.16	-1.0 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed = participants evaluable at specified timepoint.

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.

Outcome measures

Measure	Placebo n=24 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=26 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=27 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Change From Baseline in Asthma Control Test (ACT) Score at Weeks 12 and 16 Change at Week 12	4.8 units on a scale Standard Error 0.75	4.1 units on a scale Standard Error 0.73	3.6 units on a scale Standard Error 0.70
Change From Baseline in Asthma Control Test (ACT) Score at Weeks 12 and 16 Change at Week 16	4.6 units on a scale Standard Error 0.72	4.0 units on a scale Standard Error 0.71	3.7 units on a scale Standard Error 0.68

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed = participants evaluable at specified timepoint.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=32 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=32 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Weeks 12 and 16 Change at Week 12	1.0 units on a scale Standard Error 0.17	0.8 units on a scale Standard Error 0.17	0.8 units on a scale Standard Error 0.16
Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Weeks 12 and 16 Change at Week 16	0.9 units on a scale Standard Error 0.18	0.7 units on a scale Standard Error 0.18	0.8 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Weeks 12 and 16

Population: The mITT analysis set included all randomized participants who received at least a partial dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed = participants evaluable at specified timepoint.

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.

Outcome measures

Measure	Placebo n=20 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=22 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=26 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants Who Achieved FEV1:FVC Ratio ≥0.80 at Weeks 12 and 16 Week 12	0 Participants	0 Participants	0 Participants
Number of Participants Who Achieved FEV1:FVC Ratio ≥0.80 at Weeks 12 and 16 Week 16	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	11 Participants	22 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

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

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants Who Received at Least 1 Concomitant Asthma Medication	31 Participants	34 Participants	31 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: The ADA analysis set (for anti-TEV-53275 antibodies) included those participants treated with TEV-53275 in the safety analysis set. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the ADA Analysis Set.

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.

Outcome measures

Measure	Placebo n=34 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=31 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants Developing Antidrug Antibodies (ADAs) Throughout the Study	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Value	2 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

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

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=33 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants With at Least 1 Potentially Clinically Significant Urinalysis Abnormalities	4 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants With Potentially Clinically Significant Abnormal Electrocardiogram Values	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants With Injection Site Reactions Induration · Absent	31 Participants	32 Participants	29 Participants
Number of Participants With Injection Site Reactions Induration · Mild	0 Participants	2 Participants	2 Participants
Number of Participants With Injection Site Reactions Warmth · Absent	31 Participants	30 Participants	30 Participants
Number of Participants With Injection Site Reactions Warmth · Mild	0 Participants	4 Participants	1 Participants
Number of Participants With Injection Site Reactions Warmth · Severe	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Reactions Swelling · Absent	29 Participants	30 Participants	28 Participants
Number of Participants With Injection Site Reactions Tenderness · Severe	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Reactions Erythema · Absent	27 Participants	29 Participants	21 Participants
Number of Participants With Injection Site Reactions Erythema · Mild	4 Participants	4 Participants	8 Participants
Number of Participants With Injection Site Reactions Erythema · Moderate	0 Participants	1 Participants	2 Participants
Number of Participants With Injection Site Reactions Ecchymosis · Absent	31 Participants	33 Participants	30 Participants
Number of Participants With Injection Site Reactions Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Reactions Swelling · Mild	2 Participants	3 Participants	3 Participants
Number of Participants With Injection Site Reactions Erythema · Severe	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Reactions Ecchymosis · Mild	0 Participants	1 Participants	1 Participants
Number of Participants With Injection Site Reactions Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Reactions Induration · Moderate	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Reactions Induration · Severe	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Reactions Tenderness · Absent	26 Participants	32 Participants	27 Participants
Number of Participants With Injection Site Reactions Tenderness · Mild	5 Participants	1 Participants	2 Participants
Number of Participants With Injection Site Reactions Tenderness · Moderate	0 Participants	1 Participants	2 Participants
Number of Participants With Injection Site Reactions Warmth · Moderate	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Reactions Swelling · Moderate	0 Participants	1 Participants	0 Participants
Number of Participants With Injection Site Reactions Swelling · Severe	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

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.

Outcome measures

Measure	Placebo n=31 Participants Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 Participants Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 Participants Participants received TEV-53275 Dose B SC at baseline (Day 0).
Number of Participants Who Did Not Complete the Study Due to AEs	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

TEV-53275 Dose A

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

TEV-53275 Dose B

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=31 participants at risk Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 participants at risk Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 participants at risk Participants received TEV-53275 Dose B SC at baseline (Day 0).
Infections and infestations Diverticulitis	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	0.00% 0/34 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	3.2% 1/31 • Number of events 2 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	2.9% 1/34 • Number of events 1 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	2.9% 1/34 • Number of events 1 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

Other adverse events

Measure	Placebo n=31 participants at risk Participants received placebo matched to TEV-53275 SC at baseline (Day 0).	TEV-53275 Dose A n=34 participants at risk Participants received TEV-53275 Dose A SC at baseline (Day 0).	TEV-53275 Dose B n=31 participants at risk Participants received TEV-53275 Dose B SC at baseline (Day 0).
Infections and infestations COVID-19	9.7% 3/31 • Number of events 4 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	17.6% 6/34 • Number of events 6 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	3.2% 1/31 • Number of events 1 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Pain in extremity	6.5% 2/31 • Number of events 2 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	0.00% 0/34 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	5.9% 2/34 • Number of events 2 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	5.9% 2/34 • Number of events 2 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.	0.00% 0/31 • Baseline up to Week 30 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, data were summarized based upon the treatment actually received regardless of the assigned treatment. One participant was randomized to TEV-53275 Dose B but received TEV-53275 Dose A. Therefore, the participant was included in the TEV-53275 Dose A arm for the Safety Analysis Set.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 888-483-8279

Email: USMedInfo@tevapharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER