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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2023 |
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Main ID: |
NCT03052725 |
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Date of registration:
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07/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
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Scientific title:
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An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma |
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Date of first enrolment:
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March 10, 2017 |
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Target sample size:
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391 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03052725 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Czechia
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France
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Germany
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Hungary
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Israel
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Poland
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Romania
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Russian Federation
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Spain
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Ukraine
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United States
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Contacts
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Name:
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Teva Medical Expert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Teva Branded Pharmaceutical Products R&D, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
• Patient with eosinophilic asthma who completed the treatment period of a double-blind,
placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)
~~ Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
- Patient has received any reslizumab administration in any previous clinical trial
other than Studies C38072-AS-30025 and C38072-AS-30027.
- The patient has any clinically significant, uncontrolled medical condition
- The patient has another confounding underlying lung disorder
- The patient has a known/diagnosed hypereosinophilic syndrome.
- The patient has a diagnosis of malignancy within 5 years of the screening visit,
except for treated and cured non-melanoma skin cancers.
- The patient is a pregnant or lactating woman
- The patient is a current smoker (ie, has smoked within the last 6 months before
screening) or has a smoking history =10 pack-years.
- The patient is currently using any systemic immunosuppressive or immunomodulatory
agents other than OCS
- The patient has a history of allergic reaction or hypersensitivity to any component of
the study drug.
- The patient has a history of an immunodeficiency disorder including human
immunodeficiency virus (HIV).
- Additional criteria apply, please contact the investigator for more information
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Eosinophils, Asthma
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Intervention(s)
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Drug: reslizumab
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Primary Outcome(s)
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Participants With Treatment-Emergent Adverse Events (TEAEs)
[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.]
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Secondary Outcome(s)
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Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits
[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.]
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Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36
[Time Frame: Baseline (Week 0), Weeks 1, 4, 8, 24, 36]
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Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values
[Time Frame: Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits]
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Participants With Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51)
[Time Frame: Week 51]
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Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 Years (AQLQ +12) Overall Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
[Time Frame: Baseline (Week 0), Weeks 8, 24, 36]
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Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36
[Time Frame: Week 0 (baseline), Weeks 1, 4, 8, 24, 36]
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Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity
[Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, and 36]
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Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36
[Time Frame: Week 0 (baseline), Weeks 16-20, Weeks 32-36]
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Annualized Rate of Clinical Asthma Exacerbations (CAEs)
[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.]
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Participants With Potentially Clinically Significant Abnormal Vital Sign Values
[Time Frame: Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits]
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Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
[Time Frame: Baseline (Week 0), Weeks 8, 24, 36]
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Mean Number of Days of Hospital Stay During the Treatment Period
[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]
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Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period
[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]
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Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
[Time Frame: Week 0 (baseline), Weeks 8, 24, 36]
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Participants With Potentially Clinically Significant Abnormal Hematology Values
[Time Frame: Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits]
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Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses
[Time Frame: Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal]
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Secondary ID(s)
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2016-004661-23
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C38072-AS-30066
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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