| 1 |
NCT02452190 |
Completed |
Study of Reslizumab in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils |
|
- Drug: Reslizumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- PPD
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Frequency of Clinical Asthma Exacerbations
- Change in pre-bronchodilator FEV1
- Change in Asthma Quality of Life Questionnaire
- (and 7 more...)
|
468 |
All |
12 Years and older (Child, Adult, Senior) |
NCT02452190 |
C38072-AS-30025
2015-000865-29 |
|
September 28, 2015 |
December 4, 2017 |
January 31, 2018 |
May 22, 2015 |
March 22, 2018 |
|
- Teva Investigational Site 13212
Birmingham, Alabama, United States - Teva Investigational Site 13241
Flagstaff, Arizona, United States - Teva Investigational Site 13194
Glendale, Arkansas, United States - (and 211 more...)
|
| 2 |
NCT01290887 |
Terminated
Has Results |
Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma |
|
|
Interventional |
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Pharmaceutical Industries
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Participants With Treatment-Emergent Adverse Events
- Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values
- Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values
- (and 9 more...)
|
1052 |
All |
12 Years to 75 Years (Child, Adult, Senior) |
NCT01290887 |
C38072/3085
2010-024540-15 |
|
June 2011 |
January 2015 |
January 2015 |
February 7, 2011 |
June 6, 2016 |
June 6, 2016 |
- Teva Investigational Site 58
Scottsdale, Arizona, United States - Teva Investigational Site 12
Anaheim, California, United States - Teva Investigational Site 11
Fountain Valley, California, United States - (and 216 more...)
|
| 3 |
NCT01508936 |
Completed
Has Results |
Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma |
|
- Drug: Reslizumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures
- Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures
- (and 13 more...)
|
511 |
All |
18 Years to 65 Years (Adult) |
NCT01508936 |
C38072/3084 |
|
February 2012 |
August 2013 |
August 2013 |
January 12, 2012 |
June 27, 2016 |
June 27, 2016 |
- Investigational Site 861
Birmingham, Alabama, United States - Investigational Site 842
Homewood, Alabama, United States - Investigational Site 887
Jasper, Alabama, United States - (and 63 more...)
|
| 4 |
NCT01285323 |
Completed
Has Results |
A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma |
|
- Drug: Reslizumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment
- Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16
- (and 11 more...)
|
464 |
All |
12 Years to 75 Years (Child, Adult, Senior) |
NCT01285323 |
C38072/3083
2010-024006-35 |
|
March 2011 |
April 2014 |
April 2014 |
January 28, 2011 |
June 27, 2016 |
June 27, 2016 |
- Teva Investigational Site 48
Mobile, Alabama, United States - Teva Investigational Site 41
Fresno, California, United States - Teva Investigational Site 59
Long Beach, California, United States - (and 101 more...)
|
| 5 |
NCT01287039 |
Completed
Has Results |
A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma |
|
- Drug: Reslizumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment
- Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures
- (and 10 more...)
|
489 |
All |
12 Years to 75 Years (Child, Adult, Senior) |
NCT01287039 |
C38072/3082 |
|
April 2011 |
December 2013 |
March 2014 |
February 1, 2011 |
June 27, 2016 |
June 27, 2016 |
- Teva Investigational Site 58
Scottsdale, Arizona, United States - Teva Investigational Site 61
Los Angeles, California, United States - Teva Investigational Site 37
Orange, California, United States - (and 125 more...)
|
| 6 |
NCT03052725 |
Active, not recruiting |
A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma |
|
|
Interventional |
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Pharmaceutical Industries
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- frequency of adverse events including serious adverse events
- frequency of clinical asthma exacerbation (CAE)
- frequency of asthma-specific hospital admissions
- (and 15 more...)
|
391 |
All |
12 Years and older (Child, Adult, Senior) |
NCT03052725 |
C38072-AS-30066
2016-004661-23 |
|
March 10, 2017 |
September 5, 2018 |
October 3, 2018 |
February 14, 2017 |
October 31, 2017 |
|
- Teva Investigational Site 14647
Birmingham, Alabama, United States - Teva Investigational Site 14631
Bakersfield, California, United States - Teva Investigational Site 14648
Huntington Beach, California, United States - (and 123 more...)
|
| 7 |
NCT02501629 |
Completed |
An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils |
- Asthma
- Elevated Blood Eosinophils
|
- Drug: Reslizumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent reduction in daily OCS dose compared with baseline
- Proportion of patients achieving ≥50% reduction in OCS dose
- Proportion of patients achieving OCS dose reduction to ≤5mg daily dose
- (and 18 more...)
|
177 |
All |
12 Years and older (Child, Adult, Senior) |
NCT02501629 |
C38072-AS-30027
2015-001580-39 |
|
September 22, 2015 |
August 8, 2017 |
December 4, 2017 |
July 17, 2015 |
December 14, 2017 |
|
- Teva Investigational Site 13357
Bakersfield, California, United States - Teva Investigational Site 13365
Long Beach, California, United States - Teva Investigational Site 13371
Clermont, Florida, United States - (and 124 more...)
|
| 8 |
NCT01270464 |
Completed
Has Results |
A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma |
|
- Drug: Reslizumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures
- Change From Baseline in Forced Vital Capacity (FVC) Over 16 Weeks Using Mixed Model for Repeated Measures
- Change From Baseline in Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) Over 16 Weeks Using Mixed Model for Repeated Measures
- (and 11 more...)
|
315 |
All |
12 Years to 75 Years (Child, Adult, Senior) |
NCT01270464 |
C38072/3081
2010-023342-67 |
|
February 2011 |
September 2013 |
September 2013 |
January 5, 2011 |
June 6, 2016 |
June 6, 2016 |
- Teva Investigational Site 12
Anaheim, California, United States - Teva Investigational Site 11
Fountain Valley, California, United States - Teva Investigational Site 43
Los Angeles, California, United States - (and 86 more...)
|
| 9 |
NCT02559791 |
Completed |
Anti-Interleukin-5 (IL5) Monoclonal Antibody (MAb) in Prednisone-dependent Eosinophilic Asthma |
- Severe Persistent Asthma
- Eosinophilic Bronchitis
|
- Biological: Reslizumab
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- McMaster University
- Teva Pharmaceuticals USA
- St. Joseph's Healthcare Hamilton
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Sputum eosinophil percentage
- Blood eosinophil absolute number
- Sputum and blood blood Innate lymphoid cell-2 (ILC2) cells, cluster of differentiation 4 (CD4+) cells, cluster of differentiation-8 (CD8+) cells, cluster of differentiation-34 (CD34+), Eosinophil-Basophil cluster cells (Eo/B progenitor cells),
- (and 3 more...)
|
10 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02559791 |
RES-38072 |
|
October 2015 |
April 2017 |
August 2017 |
September 24, 2015 |
April 4, 2018 |
|
- Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, Canada
|
| 10 |
NCT02293265 |
Completed |
Cross-sectional Study for Identification and Description of Severe Asthma Patients |
|
- Drug: Short Acting Beta Agonist (SABA)
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Number of severe asthma patients eligible for one or more biologic treatments for asthma
- Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months
- Mean and median Charlson Comorbidity Index score
- (and 15 more...)
|
767 |
All |
12 Years and older (Child, Adult, Senior) |
NCT02293265 |
201722 |
|
December 2014 |
May 2015 |
May 2015 |
November 18, 2014 |
April 4, 2016 |
|
- GSK Investigational Site
Little Rock, Arkansas, United States - GSK Investigational Site
Fresno, California, United States - GSK Investigational Site
Los Angeles, California, United States - (and 71 more...)
|
| 11 |
NCT03470311 |
Not yet recruiting |
Benralizumab in Patients With Inadequate Response to Anti-IL5 Monoclonal Antibody Therapies |
- Severe Prednisone Dependent Eosinophilic Asthma
|
- Biological: Benralizumab
- Biological: Placebo
|
Interventional |
Phase 3 |
- McMaster University
- St. Joseph's Healthcare Hamilton
- AstraZeneca
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Sputum eosinophil percentage
- Blood eosinophils
- Forced Expired Volume in 1 second (FEV1)(pre and post bronchodilator)
- (and 5 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03470311 |
17-12992 |
|
March 2018 |
February 2019 |
June 2019 |
March 19, 2018 |
March 19, 2018 |
|
- Firestone Institute for Respiratory Health, Research - St. Joseph's Healthcare
Hamilton, Ontario, Canada
|
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