Trial Outcomes & Findings for Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils (NCT NCT02452190)

Last Updated: 2021-11-09

Results Overview

A CAE was defined as a clinically-judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are presented as adjusted means. For this analysis, the offset variable is calculated as the logarithm of treatment duration minus the summed duration of exacerbations during the treatment period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

468 participants

Primary outcome timeframe

Day 1 to Week 52

Results posted on

2021-11-09

Participant Flow

A total of 1159 participants were screened, of whom 468 participants were eligible and enrolled in a 3-week run-in period for self-monitoring. All 468 enrolled participants were then randomized at 201 centers in 20 countries.

Participant milestones

Participant milestones
Measure	Placebo Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Overall Study STARTED	232	236
Overall Study Intent to Treat (ITT) Population	230	234
Overall Study Safety Population	231	237
Overall Study COMPLETED	197	212
Overall Study NOT COMPLETED	35	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Overall Study Withdrawal by Sponsor	1	3
Overall Study Pregnancy	1	0
Overall Study Investigator's Decision	2	0
Overall Study Lack of Efficacy	3	1
Overall Study Lost to Follow-up	4	3
Overall Study Adverse Event	2	5
Overall Study Withdrawal by Subject	20	11
Overall Study Noncompliance with study drug	1	0
Overall Study Participant traveled abroad	1	0
Overall Study Death	0	1

Baseline Characteristics

Participants in the ITT population with re-bronchodilator FEV1 at baseline measures available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=230 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=234 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Total n=464 Participants Total of all reporting groups
Age, Continuous	44.8 years STANDARD_DEVIATION 17.70 • n=230 Participants	46.9 years STANDARD_DEVIATION 17.63 • n=234 Participants	45.9 years STANDARD_DEVIATION 17.68 • n=464 Participants
Sex: Female, Male Female	128 Participants n=230 Participants	144 Participants n=234 Participants	272 Participants n=464 Participants
Sex: Female, Male Male	102 Participants n=230 Participants	90 Participants n=234 Participants	192 Participants n=464 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	201 Participants n=230 Participants	216 Participants n=234 Participants	417 Participants n=464 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 Participants n=230 Participants	17 Participants n=234 Participants	43 Participants n=464 Participants
Race/Ethnicity, Customized Unknown	3 Participants n=230 Participants	1 Participants n=234 Participants	4 Participants n=464 Participants
Race/Ethnicity, Customized White	199 Participants n=230 Participants	205 Participants n=234 Participants	404 Participants n=464 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=230 Participants	15 Participants n=234 Participants	26 Participants n=464 Participants
Race/Ethnicity, Customized Asian	11 Participants n=230 Participants	6 Participants n=234 Participants	17 Participants n=464 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=230 Participants	0 Participants n=234 Participants	1 Participants n=464 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=230 Participants	0 Participants n=234 Participants	0 Participants n=464 Participants
Race/Ethnicity, Customized Other	8 Participants n=230 Participants	8 Participants n=234 Participants	16 Participants n=464 Participants
Region of Enrollment United States and Canada	58 Participants n=230 Participants	52 Participants n=234 Participants	110 Participants n=464 Participants
Region of Enrollment Europe	125 Participants n=230 Participants	135 Participants n=234 Participants	260 Participants n=464 Participants
Region of Enrollment Rest of World	47 Participants n=230 Participants	47 Participants n=234 Participants	94 Participants n=464 Participants
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	2.102 liters STANDARD_DEVIATION 0.870 • n=229 Participants • Participants in the ITT population with re-bronchodilator FEV1 at baseline measures available.	1.988 liters STANDARD_DEVIATION 0.780 • n=234 Participants • Participants in the ITT population with re-bronchodilator FEV1 at baseline measures available.	2.044 liters STANDARD_DEVIATION 0.827 • n=463 Participants • Participants in the ITT population with re-bronchodilator FEV1 at baseline measures available.
Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score	4.39 units on a scale STANDARD_DEVIATION 0.995 • n=215 Participants • Participants in the ITT population with baseline AQLQ+12 scores available	4.28 units on a scale STANDARD_DEVIATION 1.048 • n=217 Participants • Participants in the ITT population with baseline AQLQ+12 scores available	4.33 units on a scale STANDARD_DEVIATION 1.022 • n=432 Participants • Participants in the ITT population with baseline AQLQ+12 scores available
Asthma Control Questionnaire (ACQ-6) Score	2.42 units on a scale STANDARD_DEVIATION 0.812 • n=230 Participants	2.48 units on a scale STANDARD_DEVIATION 0.88 • n=234 Participants	2.45 units on a scale STANDARD_DEVIATION 0.847 • n=464 Participants
Total Asthma Symptom Scores	2.6 units on a scale STANDARD_DEVIATION 1.62 • n=222 Participants • Participants in the ITT population with total asthma symptom scores at baseline.	2.5 units on a scale STANDARD_DEVIATION 1.53 • n=224 Participants • Participants in the ITT population with total asthma symptom scores at baseline.	2.57 units on a scale STANDARD_DEVIATION 1.578 • n=446 Participants • Participants in the ITT population with total asthma symptom scores at baseline.
Blood Eosinophil Category at Baseline less than (<)300 per (/) microliter (µL)	0 Participants n=230 Participants • Participants with eosinophil count at baseline stratification data available.	1 Participants n=234 Participants • Participants with eosinophil count at baseline stratification data available.	1 Participants n=464 Participants • Participants with eosinophil count at baseline stratification data available.
Blood Eosinophil Category at Baseline 300 to <400/µL	42 Participants n=230 Participants • Participants with eosinophil count at baseline stratification data available.	48 Participants n=234 Participants • Participants with eosinophil count at baseline stratification data available.	90 Participants n=464 Participants • Participants with eosinophil count at baseline stratification data available.
Blood Eosinophil Category at Baseline greater than or equal to (≥)400/µL	188 Participants n=230 Participants • Participants with eosinophil count at baseline stratification data available.	185 Participants n=234 Participants • Participants with eosinophil count at baseline stratification data available.	373 Participants n=464 Participants • Participants with eosinophil count at baseline stratification data available.
Number of Clinical Asthma Exacerbation (CAE) Events in the Previous 12 Months	2.30 Count of Events STANDARD_DEVIATION 0.843 • n=230 Participants	2.35 Count of Events STANDARD_DEVIATION 1.043 • n=234 Participants	2.33 Count of Events STANDARD_DEVIATION 0.949 • n=464 Participants

PRIMARY outcome

Timeframe: Day 1 to Week 52

Population: ITT population included all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=234 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment	0.52 events Interval 0.347 to 0.773	0.41 events Interval 0.279 to 0.607

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: ITT includes all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received. Overall number of participants analyzed=participants with both baseline and Week 52 FEV1 values available.

Change in pre-bronchodilator FEV1 from baseline to week 52 is presented. FEV1 is a standard measurement of air movement in the lungs of participants with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Outcome measures

Outcome measures
Measure	Placebo n=193 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=211 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	0.225 liters Standard Error 0.040	0.368 liters Standard Error 0.039

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Participants of the ITT population aged 12 to 70 years. Overall number of participants analyzed=participants with both baseline and Week 52 AQLQ+12 score available.

AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Outcome measures

Outcome measures
Measure	Placebo n=188 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=197 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score	1.06 units on a scale Standard Error 0.089	1.14 units on a scale Standard Error 0.087

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: ITT population includes all randomized participants, excluding those from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received. Overall number of participants analyzed=participants with both baseline and Week 52 ACQ-6 score available.

The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Outcome measures

Outcome measures
Measure	Placebo n=197 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=212 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score	-1.14 units on a scale Standard Error 0.080	-1.22 units on a scale Standard Error 0.078

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: ITT population included all randomized participants, excluding participants from site terminated due to GCP issues. Treatment was based on treatment to which participants were randomized, regardless of which treatment they received. Overall number of participants analyzed=participants with both baseline and Week 52 total asthma symptom score.

Asthma symptoms were recorded by participant each day and night in an asthma control diary. Night score was assessed on a 5-point scale where 0=no symptoms, slept through night, to 4=bad night, no sleep. Day score was assessed on a 6-point scale where 0=very well, no symptoms, to 5= asthma very severe, unable to carry out daily activities. Total asthma symptom score was calculated by taking the sum of the night and day asthma symptom scores recorded, ranging from 0 (no symptom) to 9 (severe symptom). A lower symptom score indicated a better outcome. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Outcome measures

Outcome measures
Measure	Placebo n=128 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=143 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)	-1.4 units on a scale Standard Error 0.12	-1.5 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Day 1 to Week 52

Population: ITT population includes all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they actually received.

The percentage of asthma control days over 52 weeks of treatment is presented. An asthma control day was defined as a day on which the participant used less than or equal to 2 puffs of inhaled short-acting beta-agonist, had no nighttime awakenings, and experienced no asthma exacerbations. Analysis of the change from baseline to each visit was performed using a mixed effect MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=234 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Percentage of Asthma Control Days	7.1 percentage of days Standard Error 1.27	8.0 percentage of days Standard Error 1.24

SECONDARY outcome

Timeframe: Baseline, Week 32

Population: ITT population includes all randomized participants, excluding participants from site terminated due to GCP issues. Treatment was based on treatment to which participants were randomized, regardless of which treatment they received. Overall number of participants analyzed= participants with both baseline and Week 32 SGRQ total scores available.

The SGRQ is a 17-item questionnaire with 50 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=222 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score	-13.1 units on a scale Standard Error 1.38	-16.4 units on a scale Standard Error 1.32

SECONDARY outcome

Timeframe: Day 1 to Week 52

CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The KM method was used to estimate and compare the distributions of time to first CAE between treatment groups. Participants without an event during the treatment period were censored at either the date of the end of treatment (Week 52) visit for participants who completed treatment or at the date of last dose (+4 weeks) for participants who discontinued early.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=234 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52	0.66 percent probability Interval 0.59 to 0.72	0.66 percent probability Interval 0.59 to 0.71

SECONDARY outcome

Timeframe: Day 1 to Week 52

A CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The frequency of CAEs over 52-week treatment period is expressed as adjusted CAEs rate in 52 weeks. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=234 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment	0.05 events Interval 0.016 to 0.169	0.05 events Interval 0.015 to 0.158

SECONDARY outcome

Timeframe: Day 1 to Week 52

A moderate exacerbation was defined as a clinically judged deterioration in asthma control as determined by investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention requiring additional asthma controller medication that was not a systemic corticosteroid and did not result in an asthma-specific hospitalization or emergency department visit (that is, a medical intervention that did not otherwise meet the criteria for primary endpoint). Frequency of moderate exacerbations over 52-week treatment period is expressed as adjusted exacerbation rate in 52 weeks. Adjusted exacerbation rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=234 Participants Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
Number of Moderate Exacerbations During 52 Weeks of Treatment	0.15 events Interval 0.082 to 0.29	0.14 events Interval 0.074 to 0.25

Adverse Events

Placebo

Serious events: 19 serious events

Other events: 97 other events

Deaths: 0 deaths

Reslizumab 110 mg

Serious events: 19 serious events

Other events: 102 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=231 participants at risk Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.	Reslizumab 110 mg n=237 participants at risk Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
General disorders Injection site erythema	3.0% 7/231 • Number of events 13 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.	5.5% 13/237 • Number of events 35 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.
Infections and infestations Acute sinusitis	6.5% 15/231 • Number of events 19 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.	5.9% 14/237 • Number of events 16 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.
Infections and infestations Bronchitis	7.4% 17/231 • Number of events 23 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.	5.5% 13/237 • Number of events 14 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.
Infections and infestations Upper respiratory tract infection	8.2% 19/231 • Number of events 26 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.	11.8% 28/237 • Number of events 37 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.
Infections and infestations Viral upper respiratory tract infection	13.4% 31/231 • Number of events 42 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.	11.4% 27/237 • Number of events 45 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.
Nervous system disorders Headache	4.3% 10/231 • Number of events 19 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.	5.9% 14/237 • Number of events 28 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.
Respiratory, thoracic and mediastinal disorders Asthma	7.8% 18/231 • Number of events 25 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.	3.8% 9/237 • Number of events 15 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.2% 12/231 • Number of events 12 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.	6.8% 16/237 • Number of events 16 • From the first dose of study drug to the end of treatment visit (Week 52) for completed participants and between the first dose of study drug and 4 weeks after the last dose of study drug for participants who discontinued treatment early. Safety population includes all participants who received at least 1 dose of study drug (including from the site terminated due to GCP issues). 1 participant randomized to the placebo group was treated with reslizumab 110 mg at 1 study visit and counted in the reslizumab 110 mg arm for safety.There were no deaths during the treatment period. 1 death in the reslizumab group occurred 48 days after the participant's last dose.This participant's reason for discontinued was coded as death by the study site; but, the participant is not counted in all-cause mortality as the death occurred after the treatment period concluded.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc

Phone: 215-591-3000

Email: [email protected]

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