CLINICAL TRIALS PROFILE FOR BENRALIZUMAB
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All Clinical Trials for benralizumab
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02130882 ↗ | Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome | Active, not recruiting | AstraZeneca | Phase 2/Phase 3 | 2014-05-19 | Background: - Eosinophils are white blood cells that help fight infections. High eosinophil levels can damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study if the drug benralizumab can help people with HES. Objective: - To test if benralizumab can safely decrease eosinophils in people with HES. Eligibility: - Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have symptoms and high eosinophil levels. Design: - Participants will be screened with medical history, physical exam, and urine and blood tests. They will take simple heart and lung tests. - Participants will also have a bone marrow biopsy. A numbing medicine is injected into the outer covering of the bone. Then a needle is inserted into the bone. A fast suction movement takes bone marrow cells. - Phase 1: Participants will randomly receive either the study drug or placebo as an injection. - They will have daily visits for the next 3 days, then 4 weekly visits, and then 4 biweekly visits. Each time, they will have medical history, physical exam, blood tests, and a check of side effects. - They will receive another dose of the study drug or placebo at 1 month and 2 months after the first injection. - Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug. - At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the heart and lung tests. They will also have one other bone marrow biopsy. - After week 24, participants will receive the study drug either 6 times over 6 months or twice over 6 months. |
| NCT02130882 ↗ | Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome | Active, not recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2/Phase 3 | 2014-05-19 | Background: - Eosinophils are white blood cells that help fight infections. High eosinophil levels can damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study if the drug benralizumab can help people with HES. Objective: - To test if benralizumab can safely decrease eosinophils in people with HES. Eligibility: - Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have symptoms and high eosinophil levels. Design: - Participants will be screened with medical history, physical exam, and urine and blood tests. They will take simple heart and lung tests. - Participants will also have a bone marrow biopsy. A numbing medicine is injected into the outer covering of the bone. Then a needle is inserted into the bone. A fast suction movement takes bone marrow cells. - Phase 1: Participants will randomly receive either the study drug or placebo as an injection. - They will have daily visits for the next 3 days, then 4 weekly visits, and then 4 biweekly visits. Each time, they will have medical history, physical exam, blood tests, and a check of side effects. - They will receive another dose of the study drug or placebo at 1 month and 2 months after the first injection. - Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug. - At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the heart and lung tests. They will also have one other bone marrow biopsy. - After week 24, participants will receive the study drug either 6 times over 6 months or twice over 6 months. |
| NCT02138916 ↗ | Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History | Completed | MedImmune LLC | Phase 3 | 2014-06-13 | The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies |
| NCT02138916 ↗ | Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History | Completed | AstraZeneca | Phase 3 | 2014-06-13 | The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies |
| NCT02155660 ↗ | Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History | Completed | MedImmune LLC | Phase 3 | 2014-06-25 | The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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