A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma



Status:Terminated
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:3/23/2019
Start Date:March 10, 2017
End Date:February 22, 2018

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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

This is a multicenter, open-label (OL) extension study to obtain additional long-term safety
data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed
dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who
completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The
study consists of a screening/baseline visit followed by a 36-week OL treatment period and a
15-week follow-up period.


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
We found this trial at
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Abingdon, Virginia
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Bakersfield, California
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Birmingham, Alabama
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Boys Town, Nebraska
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Bruxelles,
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Chicago, Illinois
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Cincinnati, Ohio
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East Providence, Rhode Island
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Edmond, OK
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Falls Church, Virginia
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Homestead, Florida
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Huntington Beach, California
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Jenkintown, Pennsylvania 19046
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Knoxville, Tennessee
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Lake Success, New York
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Michigan City, Indiana
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North Dartmouth, Massachusetts
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Ocean City, New Jersey 07712
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Owensboro, Kentucky
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Warwick, Rhode Island
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