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Sponsored by: |
Ception Therapeutics |
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Information provided by: | Ception Therapeutics |
ClinicalTrials.gov Identifier: | NCT00587288 |
The purpose of this study is to determine the effectiveness and safety of reslizumab (the drug under study) in the treatment of subjects with poorly controlled asthma.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Biological: Reslizumab Other: Saline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation |
Estimated Enrollment: | 120 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Reslizumab 3 mg/kg
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Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 day cycle (+/- 7 days) Number of Cycles=4
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2: Placebo Comparator
Saline
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Other: Saline
IV (in the vein) on Day 0 of each 28 day cycle (+/-7 days) Number of Cycles=4
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | H. Jeffrey Wilkins, M.D. | Ception Therapeutics |
Responsible Party: | Ception Therapeutics ( H. Jeffrey Wilkins, M.D./ Senior Vice-President of Clinical Development ) |
Study ID Numbers: | Res-5-0010 |
Study First Received: | January 4, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00587288 |
Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee; United States: Food and Drug Administration; United States: Institutional Review Board |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity Inflammation |
Immune System Diseases Bronchial Diseases |