Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:2/8/2019
Start Date:September 28, 2015
End Date:January 31, 2018

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A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

The primary objective of this study is to determine the effect of reslizumab (110 mg)
administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and
adolescents with asthma and elevated blood eosinophils who are inadequately controlled on
standard-of-care asthma therapy.


Inclusion Criteria:

- Written informed consent is obtained.

- The participant is male or female, 12 years of age and older, with a diagnosis of
asthma.

- The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility
according to standard American Thoracic Society (ATS) or European Respiratory Society
(ERS) protocol.

- The participant has required an inhaled corticosteroid.

- The participant has required an additional asthma controller medication besides
inhaled corticosteroids.

- The participant has a history of asthma exacerbation.

- The participant must be willing and able to comply with study restrictions, perform
requisite procedures and remain at the clinic for the required duration during the
study period, and be willing to return to the clinic for the follow-up evaluation as
specified in this protocol.

- Additional criteria may apply, please contact the investigator for more
information

Exclusion Criteria:

- The participant has any clinically significant, uncontrolled medical condition
(treated or untreated) that would interfere with the study schedule or procedures,
interpretation of efficacy results, or compromise the patient's safety.

- The participant has another confounding underlying lung disorder

- The participant has a known hypereosinophilic syndrome.

- The participant has a diagnosis of malignancy within 5 years of the screening visit,
except for treated and cured non-melanoma skin cancers.

- The participant is a pregnant or lactating woman, or intends to become pregnant during
the study. Any woman becoming pregnant during the study will be withdrawn from the
study.

- The participant is a current smoker or has a smoking history.

- The participated in a clinical trial within 30 days or 5 half-lives of the
investigational drug before screening, whichever is longer.

- The participant was previously exposed to reslizumab.

- The participant has a history of an immunodeficiency disorder including human
immunodeficiency virus (HIV).

- The participant has current or suspected drug and alcohol abuse.

- The participant has an active helminthic parasitic infection or was treated for one
within 6 months of screening.

- The participant has a history of allergic reaction or hypersensitivity to any
component of the study drug.

- Additional criteria may apply, please contact the investigator for more
information
We found this trial at
72
sites
Medford, Oregon 97504
1355
mi
from
Medford, OR
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Abingdon, Virginia
873
mi
from
Abingdon, VA
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884
mi
from
Albany, GA
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?
mi
from
Arlington, TX
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1314
mi
from
Aventura, FL
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Bakersfield, California
1185
mi
from
Bakersfield, CA
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Belleville, New Jersey
1279
mi
from
Belleville, NJ
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Bethlehem, Pennsylvania
1217
mi
from
Bethlehem, PA
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Biloxi, Mississippi
720
mi
from
Biloxi, MS
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Birmingham, Alabama
683
mi
from
Birmingham, AL
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Boys Town, Nebraska
258
mi
from
Boys Town, NE
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5602
mi
from
Buenos Aires,
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811
mi
from
Buford, GA
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Canoga Park, California
1184
mi
from
Canoga Park, CA
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Chicago, Illinois
610
mi
from
Chicago, IL
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Cincinnati, Ohio
726
mi
from
Cincinnati, OH
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Cincinnati, Ohio
726
mi
from
Cincinnati, OH
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895
mi
from
Cleveland, OH
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398
mi
from
Corsicana, TX
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348
mi
from
Dallas, TX
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409
mi
from
Denver, CO
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East Providence, Rhode Island
1425
mi
from
East Providence, RI
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146
mi
from
Edmond, OK
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1113
mi
from
Fairfax, VA
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Falls Church, Virginia
1119
mi
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Falls Church, VA
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Flagstaff, Arizona 86001
787
mi
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Flagstaff, AZ
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Fort Lauderdale, Florida
?
mi
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Fort Lauderdale, FL
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Fresno, California
1207
mi
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Fresno, CA
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Glendale, Arkansas 71854
365
mi
from
Glendale, AR
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Huntington Beach, California
1163
mi
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Huntington Beach, CA
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Jenkintown, Pennsylvania 19046
1227
mi
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Jenkintown, PA
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Kissimmee, Florida
1149
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Kissimmee, FL
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Knoxville, Tennessee
777
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Knoxville, TN
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Lafayette, Louisiana
616
mi
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Lafayette, LA
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Lawrenceville, Georgia
816
mi
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Lawrenceville, GA
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186
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Lenexa, KS
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Lincoln, Rhode Island
1422
mi
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Lincoln, RI
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Long Beach, California
1172
mi
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Long Beach, CA
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1321
mi
from
Miami, FL
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1321
mi
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Miami, FL
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1321
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Miami, FL
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1321
mi
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Miami, FL
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Michigan City, Indiana
641
mi
from
Michigan City, IN
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1328
mi
from
Napa, CA
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New Hyde Park, New York
1303
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New Hyde Park, NY
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New Port Richey, Florida
1091
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New Port Richey, FL
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New York, New York
1286
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New York, NY
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New York, New York
1286
mi
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New York, NY
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510
mi
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Normal, IL
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North Dartmouth, Massachusetts
1445
mi
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North Dartmouth, MA
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Ocean City, New Jersey 07712
1257
mi
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Ocean City, NJ
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Oklahoma City, Oklahoma
158
mi
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Oklahoma City, OK
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1141
mi
from
Orlando, FL
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1141
mi
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Orlando, FL
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Owensboro, Kentucky
584
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Owensboro, KY
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Pembroke Pines, Florida
1304
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Pembroke Pines, FL
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Philadelphia, Pennsylvania
1225
mi
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Philadelphia, PA
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Pittsburgh, Pennsylvania
971
mi
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Pittsburgh, PA
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762
mi
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Provo, UT
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Richmond, Virginia
1113
mi
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Richmond, VA
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Saint Louis, Missouri
418
mi
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Saint Louis, MO
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San Antonio, Texas
576
mi
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San Antonio, TX
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San Jose, California
1314
mi
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San Jose, CA
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434
mi
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Shiloh, IL
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Spokane, Washington
1201
mi
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Spokane, WA
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Stockton, California
1276
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Stockton, CA
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Tallahassee, Florida
923
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Tallahassee, FL
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Tampa, Florida
1117
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Tampa, FL
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804
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Toledo, OH
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428
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Waco, TX
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Walnut Creek, California
1319
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Walnut Creek, CA
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Waterbury, Connecticut
1338
mi
from
Waterbury, CT
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