12 and older, any sex, with Eosinophils, Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants With Treatment-Emergent Adverse Events (TEAEs)Primary· Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient
>=1 TEAE
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
102
Reslizumab 110 mg; Previous Treatment Reslizumab
114
>=1 treatment-related TEAE
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
7
Reslizumab 110 mg; Previous Treatment Reslizumab
6
>=1 serious TEAE
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
5
Reslizumab 110 mg; Previous Treatment Reslizumab
11
>=1 treatment-related, serious TEAE
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
0
>=1 TEAE leading to discontinuation
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2
Reslizumab 110 mg; Previous Treatment Reslizumab
0
>=1 TEAE leading to death
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Participants With Potentially Clinically Significant Abnormal Hematology ValuesSecondary· Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits
Participants are included in the counts if the worst study value reaches the following clinically significant levels:
Eosinophils (high): \>=1.5\*10\^9/L and increase \>0 Hematocrit (low): \>=18 years old: \<0.32 L/L for females; \<0.37 L/L for males plus a decrease \>0 for both or 12 to \<18 years old: \<0.30 L/L and a decrease \>0 for both females and males Hemoglobin (low): \>=18 years old: \<=95 g/L and decrease \>0; 12 to \<18 years old: \<=100 g/L and decrease \>0 Leukocytes (high): \>=20\*10\^9/L and increase \>0 Leukocytes (low): \<=3\*10\^9/L and decrease \>0 Neutrophils (low): \<=1\
Participants with >=1 abnormality
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
8
Reslizumab 110 mg; Previous Treatment Reslizumab
5
Eosinophils (high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
1
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Hematocrit (low)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
4
Reslizumab 110 mg; Previous Treatment Reslizumab
2
Hemoglobin (low)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Leukocytes (high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
1
Leukocytes (low)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Neutrophils (low)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
1
Reslizumab 110 mg; Previous Treatment Reslizumab
1
Platelets
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
1
Participants With Potentially Clinically Significant Abnormal Serum Chemistry ValuesSecondary· Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits
Participants are included in the counts if the worst study value reaches the following clinically significant levels:
Alanine Aminotransferase (high): \>=3\* upper limit of normal (ULN) and increase \>0 Aspartate Aminotransferase (high): \>=3\* upper limit of normal (ULN) and increase \>0 Bilirubin (high): \>=34.2 micromol/L and increase \>0 Blood Urea Nitrogen (high): \>=10.71 mmol/L and increase \>0 Creatine Phosphokinase (high): \>10\* ULN and increase \>0 Creatine Phosphokinase (medium high): \>=3.1\*ULN and \<=10\*ULN and increase \>0 Creatinine (high): \>=177 micromol/L and increase \>0
Participants with >=1 abnormality
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
12
Reslizumab 110 mg; Previous Treatment Reslizumab
10
Alanine Aminotransferase (high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
1
Reslizumab 110 mg; Previous Treatment Reslizumab
2
Aspartate Aminotransferase (high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
1
Reslizumab 110 mg; Previous Treatment Reslizumab
1
Bilirubin (high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2
Reslizumab 110 mg; Previous Treatment Reslizumab
1
Blood Urea Nitrogen (high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2
Reslizumab 110 mg; Previous Treatment Reslizumab
4
Creatine Phosphokinase (high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2
Reslizumab 110 mg; Previous Treatment Reslizumab
1
Creatine Phosphokinase (medium high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
6
Reslizumab 110 mg; Previous Treatment Reslizumab
4
Creatinine (high)
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
1
Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall SeveritySecondary· Weeks 4, 8, 12, 16, 20, 24, 28, and 36
The worst finding for participants in each tolerability and injection site domain from all treatment weeks is summarized. Local tolerability at the injection site was assessed approximately 1 hour after study drug administration.
Severity was rated on a 4-level scale of none, mild, moderate and severe.
Pain - None
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
191
Reslizumab 110 mg; Previous Treatment Reslizumab
194
Pain - Mild
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
3
Reslizumab 110 mg; Previous Treatment Reslizumab
2
Pain - Moderate
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Pain - Severe
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Tenderness - None
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
193
Reslizumab 110 mg; Previous Treatment Reslizumab
192
Tenderness - Mild
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
1
Reslizumab 110 mg; Previous Treatment Reslizumab
4
Tenderness - Moderate
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Tenderness - Severe
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Participants With Potentially Clinically Significant Abnormal Vital Sign ValuesSecondary· Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits
Participants are included in the counts if the worst study value reaches the following clinically significant levels:
Diastolic blood pressure (high): \>100 mmHg and increase \>=12 for participants \>=18 years; \>85 mmHg and increase \>=12 for participants 12 - \< 18 years Pulse rate (high): \>100 beats/minute and increase \>=12 Respiratory rate (high): \>24 breaths/minute and increase \>=10 for participants \>=18 years \>20 breaths/minute and increase \>=10 for participants 12 - \< 18 years Systolic blood pressure (high): \>160 mmHg and increase \>=30 for participants \>=18 years; \>130 mmHg
Participants with >=1 abnormality
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
20
Reslizumab 110 mg; Previous Treatment Reslizumab
16
Diastolic Blood Pressure - High
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0
Reslizumab 110 mg; Previous Treatment Reslizumab
1
Pulse Rate - High
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
1
Reslizumab 110 mg; Previous Treatment Reslizumab
2
Respiratory Rate - High
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Systolic Blood Pressure - High
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Temperature - High
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
1
Reslizumab 110 mg; Previous Treatment Reslizumab
0
Temperature - Low
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
14
Reslizumab 110 mg; Previous Treatment Reslizumab
13
Annualized Rate of Clinical Asthma Exacerbations (CAEs)Secondary· Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early.
Annual rate is defined as the number of events/(duration of treatment \[days\]/365.25).
Participants with zero events are included.
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.42
± 1.104
Reslizumab 110 mg; Previous Treatment Reslizumab
0.70
± 1.538
Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room VisitsSecondary· Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early.
Annual rate is defined as the number of events/(duration of treatment \[days\]/365.25).
Participants with zero events are included.
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.06
± 0.362
Reslizumab 110 mg; Previous Treatment Reslizumab
0.11
± 0.514
Mean Number of Days of Hospital Stay During the Treatment PeriodSecondary· Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug
Participants with no hospitalizations are included.
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.25
± 1.658
Reslizumab 110 mg; Previous Treatment Reslizumab
1.02
± 7.848
Mean Number of School/Work Days Missed Due to Asthma During the Treatment PeriodSecondary· Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug
Participants with no school or work days missed due to asthma are included in the counts.
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.11
± 1.202
Reslizumab 110 mg; Previous Treatment Reslizumab
0.00
± 0.000
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36Secondary· Week 0 (baseline), Weeks 8, 24, 36
The FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second, measured in liters.
Pre-bronchodilator spirometry assessments at designated clinic visits (weeks 0, 8, and 24, and 36) should only be performed after withholding short-acting bronchodilators (ie, inhaled short-acting beta-adrenergic agonists and/or short-acting anticholinergics) for at least 6 hours and long-acting bronchodilators ie, inhaled long-acting beta-adrenergic agonists and long acting anticholinergic agents) for at least 12 or 24 hours, according to their labeled dose schedule.
Baseline - observed value
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2.162
± 0.980
Reslizumab 110 mg; Previous Treatment Reslizumab
2.117
± 0.927
Change at Week 8
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.099
± 0.704
Reslizumab 110 mg; Previous Treatment Reslizumab
0.031
± 0.529
Change at Week 24
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.169
± 0.851
Reslizumab 110 mg; Previous Treatment Reslizumab
-0.020
± 0.472
Change at Week 36
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.245
± 0.677
Reslizumab 110 mg; Previous Treatment Reslizumab
0.010
± 0.550
Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36Secondary· Week 0 (baseline), Weeks 1, 4, 8, 24, 36
A weekly average of daily morning ambulatory FEV1 (measured by the handheld spirometry device) was derived using 7-day window intervals. The average was calculated as the sum of all values divided by the number of non-missing assessments. There will be no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.
Baseline - observed value
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
2.057
± 0.814
Reslizumab 110 mg; Previous Treatment Reslizumab
2.027
± 0.847
Change at Week 1
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.002
± 0.345
Reslizumab 110 mg; Previous Treatment Reslizumab
-0.044
± 0.291
Change at Week 4
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.051
± 0.490
Reslizumab 110 mg; Previous Treatment Reslizumab
-0.049
± 0.319
Change at Week 8
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.028
± 0.463
Reslizumab 110 mg; Previous Treatment Reslizumab
-0.039
± 0.345
Change at Week 24
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.051
± 0.492
Reslizumab 110 mg; Previous Treatment Reslizumab
-0.062
± 0.403
Change at Week 36
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
0.061
± 0.273
Reslizumab 110 mg; Previous Treatment Reslizumab
-0.053
± 0.465
Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36Secondary· Week 0 (baseline), Weeks 16-20, Weeks 32-36
Daily OCS dose is defined as total OCS dose in a day (accounting for reported dose and dose frequency) and converting the total daily dose to a prednisone-equivalent dose.
Baseline dose is the prescribed OCS dose on the day of first dose of study drug in this study. Dose at Weeks 16-20 and 32-36 is the mean of all daily OCS doses during the week range.
Percent change = 100 \* (absolute change / baseline dose)
% change at Week 16-20
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
-2.19
± 51.347
Reslizumab 110 mg; Previous Treatment Reslizumab
-6.96
± 40.904
% change at Week 32-36
Group
Value
95% CI
Reslizumab 110 mg; Previous Treatment Placebo
-8.44
± 24.236
Reslizumab 110 mg; Previous Treatment Reslizumab
-8.75
± 29.666
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Reslizumab 110 mg
Serious: 16/390 (4%)
Deaths: 0/390
Serious adverse events (18 terms)
Reaction
System
Reslizumab 110 mg
Pneumonia
Infections and infestations
—
Asthma
Respiratory, thoracic and mediastinal disorders
—
Abdominal distension
Gastrointestinal disorders
—
Dysphagia
Gastrointestinal disorders
—
Inguinal hernia
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Chest pain
General disorders
—
Appendicitis
Infections and infestations
—
Influenza
Infections and infestations
—
Peritonsillar abscess
Infections and infestations
—
Post procedural haematoma
Injury, poisoning and procedural complications
—
Neck pain
Musculoskeletal and connective tissue disorders
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
Synovial cyst
Musculoskeletal and connective tissue disorders
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D, Inc.
Last refreshed: 14 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03052725.