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
34
sites
New York, New York
2432
mi
from 91732
New York, NY
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Abingdon, Virginia
2025
mi
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Abingdon, VA
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2319
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Aventura, FL
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Bakersfield, California
106
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Bakersfield, CA
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Birmingham, Alabama
1784
mi
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Birmingham, AL
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Boys Town, Nebraska
1291
mi
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Boys Town, NE
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?
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Bruxelles,
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1936
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Buford, GA
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Chicago, Illinois
1729
mi
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Chicago, IL
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Cincinnati, Ohio
1880
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Cincinnati, OH
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2032
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Cleveland, OH
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1252
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Corsicana, TX
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1224
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Dallas, TX
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East Providence, Rhode Island
2564
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East Providence, RI
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1167
mi
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Edmond, OK
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Falls Church, Virginia
2274
mi
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Falls Church, VA
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Homestead, Florida
2314
mi
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Homestead, FL
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Huntington Beach, California
27
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Huntington Beach, CA
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Jenkintown, Pennsylvania 19046
2376
mi
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Jenkintown, PA
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Knoxville, Tennessee
1923
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Knoxville, TN
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Lafayette, Louisiana
1539
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Lafayette, LA
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Lake Success, New York
2448
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Lake Success, NY
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2320
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Miami, FL
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Michigan City, Indiana
1765
mi
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Michigan City, IN
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North Dartmouth, Massachusetts
2585
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North Dartmouth, MA
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Ocean City, New Jersey 07712
2410
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Ocean City, NJ
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2184
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Orlando, FL
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Owensboro, Kentucky
1739
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Owensboro, KY
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Pittsburgh, Pennsylvania
2119
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Pittsburgh, PA
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550
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Provo, UT
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Stockton, California
324
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Stockton, CA
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Tallahassee, Florida
1977
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Tallahassee, FL
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Tampa, Florida
2136
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Tampa, FL
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Warwick, Rhode Island
2562
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Warwick, RI
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