Back to resultsA Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEMP1972A
MEMP1972A
MEMP1972A
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Adult patients, 18 to 75 years of age inclusive
- Body weight >/= 40 kg
- Physician's diagnosis of asthma for at least 12 months
- Evidence of documented bronchodilator reversibility as defined by protocol
- Prebronchodilator FEV1 >/= 40% and </= 80% predicted at Visit 1
- Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
- History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
- Inadequately controlled asthma despite compliance with asthma controller therapy
Exclusion Criteria:
- Asthma exacerbation requiring systemic steroids in the 30 days prior to Visit 1
- Pre-existing active lung disease other than asthma
- Any infection
- Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
- Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
- Current substance abuse
- Former smoker with >10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
- History of anaphylaxis
- Pregnant and lactating women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MEMP1972A 150 mg
MEMP1972A 300 mg
MEMP1972A 450 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36
Secondary Outcome Measures
Relative change in pre-bronchodilator FEV1 (volume)
Relative change in FEV1 (volume)
Change in asthma symptoms
Change in asthma symptoms
Proportion of "well-controlled" weeks (no nighttime awakenings due to asthma symptoms and </= 2 days of SABA use per weeks, as documented by patient diary) from Week 24 to Week 36
Safety: Incidence of adverse events
Incidence of anti-therapeutic antibodies (ATAs)
Pharmacokinetics: Area under the concentration-time curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01582503
Brief Title
A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
Official Title
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
578 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEMP1972A 150 mg
Arm Type
Experimental
Arm Title
MEMP1972A 300 mg
Arm Type
Experimental
Arm Title
MEMP1972A 450 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MEMP1972A
Intervention Description
Subcutaneous repeating dose
Intervention Type
Drug
Intervention Name(s)
MEMP1972A
Intervention Description
Subcutaneous repeating dose
Intervention Type
Drug
Intervention Name(s)
MEMP1972A
Intervention Description
Subcutaneous repeating dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subcutaneous repeating dose
Primary Outcome Measure Information:
Title
Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Relative change in pre-bronchodilator FEV1 (volume)
Time Frame
from baseline to Week 12
Title
Relative change in FEV1 (volume)
Time Frame
from baseline to Week 36
Title
Change in asthma symptoms
Time Frame
from baseline to Week 12
Title
Change in asthma symptoms
Time Frame
from baseline to Week 36
Title
Proportion of "well-controlled" weeks (no nighttime awakenings due to asthma symptoms and </= 2 days of SABA use per weeks, as documented by patient diary) from Week 24 to Week 36
Time Frame
12 weeks
Title
Safety: Incidence of adverse events
Time Frame
48 weeks
Title
Incidence of anti-therapeutic antibodies (ATAs)
Time Frame
84 weeks
Title
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time Frame
Pre- and post-dose Weeks 0, 4, 12, 24 and 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, 18 to 75 years of age inclusive
Body weight >/= 40 kg
Physician's diagnosis of asthma for at least 12 months
Evidence of documented bronchodilator reversibility as defined by protocol
Prebronchodilator FEV1 >/= 40% and </= 80% predicted at Visit 1
Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
Inadequately controlled asthma despite compliance with asthma controller therapy
Exclusion Criteria:
Asthma exacerbation requiring systemic steroids in the 30 days prior to Visit 1
Pre-existing active lung disease other than asthma
Any infection
Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
Current substance abuse
Former smoker with >10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
History of anaphylaxis
Pregnant and lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
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United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
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United States
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Mission Viejo
State/Province
California
ZIP/Postal Code
92691
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United States
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95762
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United States
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Redwood City
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California
ZIP/Postal Code
94063
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United States
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Stockton
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California
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95207
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United States
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Torrance
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California
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90505
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United States
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Upland
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California
ZIP/Postal Code
91786
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United States
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Centennial
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Colorado
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80112
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United States
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Denver
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Colorado
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80206
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United States
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New Haven
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Connecticut
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06510
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United States
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Tampa
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Florida
ZIP/Postal Code
33613
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United States
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Winter Park
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Florida
ZIP/Postal Code
32789
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United States
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Albany
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Georgia
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31707
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United States
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Twin Falls
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Idaho
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83301
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United States
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Normal
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Illinois
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61761
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United States
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River Forest
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Illinois
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60305
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United States
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Iowa City
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Iowa
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52242
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United States
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Overland Park
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Kansas
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66210
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United States
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Louisville
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Kentucky
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40223
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United States
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Baltimore
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Maryland
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21236
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United States
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Saint Louis
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63141
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St Louis
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Missouri
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63141
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Bellevue
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Nebraska
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68123
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United States
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Omaha
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Nebraska
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68130
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United States
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Edison
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New Jersey
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08820
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United States
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Teaneck
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New Jersey
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07666
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United States
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Bronx
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New York
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10461
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United States
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Winston-Salem
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North Carolina
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27103
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United States
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Canton
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Ohio
ZIP/Postal Code
44718
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United States
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Centerville
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Ohio
ZIP/Postal Code
45458
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United States
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Cincinnati
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Ohio
ZIP/Postal Code
45231
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United States
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Oklahoma City
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Oklahoma
ZIP/Postal Code
73120
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United States
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Tulsa
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Oklahoma
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74136
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United States
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Medford
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Oregon
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97504
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United States
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Philadelphia
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19140
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United States
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Pennsylvania
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15241
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United States
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Providence
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02906
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United States
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Warwick
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Rhode Island
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02865
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United States
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Charleston
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South Carolina
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29407
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United States
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El Paso
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79903
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United States
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El Paso
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Texas
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79925
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United States
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San Antonio
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Texas
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78224
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United States
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San Antonio
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Texas
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78229
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United States
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Waco
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Texas
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76712
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Murray
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Utah
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84107
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Fairfax
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Virginia
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22030
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Spokane
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99204
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Greenfield
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Wisconsin
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53228
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United States
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Buenos Aires
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1056
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Argentina
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Buenos Aires
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1186
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Argentina
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Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1425BEN
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Argentina
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Florencio Varela
ZIP/Postal Code
1888
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Argentina
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Mendoza
ZIP/Postal Code
5500
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Argentina
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Quilmes
ZIP/Postal Code
1878
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Argentina
City
Rosario
ZIP/Postal Code
2000
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Argentina
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Salta
ZIP/Postal Code
4400
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Argentina
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San Miguel de Tucuman
ZIP/Postal Code
4000
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Argentina
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Tucuman
ZIP/Postal Code
4000
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Argentina
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Gembloux
ZIP/Postal Code
5030
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Belgium
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Halen
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3545
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Belgium
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Leuven
ZIP/Postal Code
3000
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Belgium
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Pleven
ZIP/Postal Code
5800
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Bulgaria
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Plovdiv
ZIP/Postal Code
4003
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Bulgaria
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Ruse
ZIP/Postal Code
7002
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Bulgaria
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Sofia
ZIP/Postal Code
1233
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Bulgaria
City
Sofia
ZIP/Postal Code
1336
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Bulgaria
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Sofia
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1431
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Bulgaria
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Sofia
ZIP/Postal Code
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Bulgaria
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Sofia
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1680
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Bulgaria
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6003
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9010
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Bulgaria
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British Columbia
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Canada
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Ontario
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K1Y 4G2
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Canada
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Toronto
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Ontario
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M4V 1R2
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Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
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Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M2
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Canada
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Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
14050
Country
Germany
City
Bochum
ZIP/Postal Code
44789
Country
Germany
City
Coswig
ZIP/Postal Code
01640
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Geesthacht
ZIP/Postal Code
21502
Country
Germany
City
Jena
ZIP/Postal Code
07740
Country
Germany
City
Landsberg
ZIP/Postal Code
86899
Country
Germany
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Muenster
ZIP/Postal Code
48149
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Germany
City
Balassagyarmat
ZIP/Postal Code
2660
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Hungary
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
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Mosonmagyaróvar
ZIP/Postal Code
9200
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Hungary
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Guadalajara
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44130
Country
Mexico
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Mexico
ZIP/Postal Code
03100
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Mexico
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Nuevo Leon
ZIP/Postal Code
64710
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Mexico
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Auckland
ZIP/Postal Code
1023
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New Zealand
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Aucklund
ZIP/Postal Code
2025
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New Zealand
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Christchurch
ZIP/Postal Code
8011
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Wellington
Country
New Zealand
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Lima
ZIP/Postal Code
31
Country
Peru
City
Lima
ZIP/Postal Code
Lima 07
Country
Peru
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
City
Lima
ZIP/Postal Code
Lima 21
Country
Peru
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
City
Lima
ZIP/Postal Code
Lima 33
Country
Peru
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
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Miraflores
ZIP/Postal Code
Lima 18
Country
Peru
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Piura
ZIP/Postal Code
20000
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Peru
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Bialystok
ZIP/Postal Code
15-003
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Poland
City
Bialystok
ZIP/Postal Code
15-010
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Poland
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Katowice
ZIP/Postal Code
40-752
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Poland
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
City
Krakow
ZIP/Postal Code
31-023
Country
Poland
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Lublin
ZIP/Postal Code
20-552
Country
Poland
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
City
Wroclaw
ZIP/Postal Code
54-239
Country
Poland
City
Brasov
ZIP/Postal Code
16
Country
Romania
City
Brasov
ZIP/Postal Code
500283
Country
Romania
City
Bucharest
ZIP/Postal Code
050159
Country
Romania
City
Bucuresti
ZIP/Postal Code
011426
Country
Romania
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400349
Country
Romania
City
Craiova
ZIP/Postal Code
200515
Country
Romania
City
Deva
ZIP/Postal Code
330084
Country
Romania
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
City
S. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214006
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
City
Dnepropetrovsk
ZIP/Postal Code
49000
Country
Ukraine
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
City
Dnipropetrovsk
ZIP/Postal Code
49066
Country
Ukraine
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
City
Kyiv
ZIP/Postal Code
02232
Country
Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
City
Odessa
ZIP/Postal Code
65114
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
26993628
Citation
Harris JM, Maciuca R, Bradley MS, Cabanski CR, Scheerens H, Lim J, Cai F, Kishnani M, Liao XC, Samineni D, Zhu R, Cochran C, Soong W, Diaz JD, Perin P, Tsukayama M, Dimov D, Agache I, Kelsen SG. A randomized trial of the efficacy and safety of quilizumab in adults with inadequately controlled allergic asthma. Respir Res. 2016 Mar 18;17:29. doi: 10.1186/s12931-016-0347-2.
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A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
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