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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00394654 |
This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Biological: MEDI-528 Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase2A, Randomized, Multicenter Study to Evaluate the Efficacy of MEDI-528 a Humanized Anti-Interleukin-9 Monoclonal Anti-Body, on Late Asthmatic Response (LAR) Induced By Allergen Inhalation In Adults With Atopic Asthma |
Enrollment: | 30 |
Study Start Date: | November 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
MEDI-528
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Biological: MEDI-528
MEDI-528 (9.0 mg/kg) as a single IV infusion
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2: Placebo Comparator
Placebo
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Other: Placebo
Placebo as a single IV infusion
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This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
Hopital Laval | |
Quebec, Canada, G1V 4G5 | |
Canada, Ontario | |
McMaster University | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Canada, Saskatchewan | |
University of Saskatchewan | |
Saskatoon, Saskatchewan, Canada, S7N 0W8 |
Study Director: | Nestor Molfino, M.D. | MedImmune LLC |
Responsible Party: | MedImmune ( Nestor Molfino, M.D. ) |
Study ID Numbers: | MI-CP138 |
Study First Received: | October 31, 2006 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00394654 History of Changes |
Health Authority: | Canada: Health Canada |
Antibodies, Monoclonal Antibodies Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Immunoglobulins Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |