A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
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)
2 other identifiers
interventional
578
14 countries
145
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Apr 2012
Typical duration for phase_2 asthma
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 2, 2016
November 1, 2016
2.1 years
April 19, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
36 weeks
Secondary Outcomes (8)
Relative change in pre-bronchodilator FEV1 (volume)
from baseline to Week 12
Relative change in FEV1 (volume)
from baseline to Week 36
Change in asthma symptoms
from baseline to Week 12
Change in asthma symptoms
from baseline to Week 36
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
12 weeks
- +3 more secondary outcomes
Study Arms (4)
MEMP1972A 150 mg
EXPERIMENTALMEMP1972A 300 mg
EXPERIMENTALMEMP1972A 450 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (145)
Unknown Facility
Birmingham, Alabama, 35209, United States
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Bakersfield, California, 93301, United States
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Costa Mesa, California, 92626, United States
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Fountain Valley, California, 92708, United States
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Long Beach, California, 90808, United States
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Mission Viejo, California, 92691, United States
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Rancho Cordova, California, 95762, United States
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Redwood City, California, 94063, United States
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Stockton, California, 95207, United States
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Torrance, California, 90505, United States
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Upland, California, 91786, United States
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Centennial, Colorado, 80112, United States
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Denver, Colorado, 80206, United States
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New Haven, Connecticut, 06510, United States
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Tampa, Florida, 33613, United States
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Winter Park, Florida, 32789, United States
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Albany, Georgia, 31707, United States
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Twin Falls, Idaho, 83301, United States
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Normal, Illinois, 61761, United States
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River Forest, Illinois, 60305, United States
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Iowa City, Iowa, 52242, United States
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Overland Park, Kansas, 66210, United States
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Louisville, Kentucky, 40223, United States
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Baltimore, Maryland, 21236, United States
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St Louis, Missouri, 63141, United States
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Bellevue, Nebraska, 68123, United States
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Omaha, Nebraska, 68130, United States
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Edison, New Jersey, 08820, United States
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Teaneck, New Jersey, 07666, United States
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The Bronx, New York, 10461, United States
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Winston-Salem, North Carolina, 27103, United States
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Canton, Ohio, 44718, United States
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Centerville, Ohio, 45458, United States
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Cincinnati, Ohio, 45231, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74136, United States
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Medford, Oregon, 97504, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Providence, Rhode Island, 02906, United States
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Warwick, Rhode Island, 02865, United States
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Charleston, South Carolina, 29407, United States
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El Paso, Texas, 79903, United States
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El Paso, Texas, 79925, United States
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San Antonio, Texas, 78224, United States
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San Antonio, Texas, 78229, United States
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Waco, Texas, 76712, United States
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Murray, Utah, 84107, United States
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Fairfax, Virginia, 22030, United States
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Spokane, Washington, 99204, United States
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Greenfield, Wisconsin, 53228, United States
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Buenos Aires, 1056, Argentina
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Buenos Aires, 1186, Argentina
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Buenos Aires, C1425BEN, Argentina
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Mendoza, 5500, Argentina
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Quilmes, 1878, Argentina
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Rosario, 2000, Argentina
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Salta, 4400, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Gembloux, 5030, Belgium
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Halen, 3545, Belgium
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Leuven, 3000, Belgium
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Pleven, 5800, Bulgaria
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Plovdiv, 4003, Bulgaria
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Rousse, 7002, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1336, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1680, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9010, Bulgaria
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Vancouver, British Columbia, V5Z 1M9, Canada
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Mississauga, Ontario, L5A 3V4, Canada
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Ottawa, Ontario, K1Y 4G2, Canada
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Toronto, Ontario, M4V 1R2, Canada
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Toronto, Ontario, M5T 3A9, Canada
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Toronto, Ontario, M6H 3M2, Canada
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Berlin, 10117, Germany
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Berlin, 14050, Germany
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Bochum, 44789, Germany
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Coswig, 01640, Germany
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Freiburg im Breisgau, 79106, Germany
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Geesthacht, 21502, Germany
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Jena, 07740, Germany
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Landsberg, 86899, Germany
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Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Münster, 48149, Germany
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Balassagyarmat, 2660, Hungary
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Debrecen, 4031, Hungary
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Mosonmagyaróvar, 9200, Hungary
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Guadalajara, 44130, Mexico
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México, 03100, Mexico
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Nuevo León, 64710, Mexico
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Auckland, 1023, New Zealand
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Aucklund, 2025, New Zealand
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Christchurch, 8011, New Zealand
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Dunedin, New Zealand
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Hamilton, New Zealand
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Wellington, New Zealand
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Lima, 31, Peru
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Lima, Lima 07, Peru
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Lima, Lima 1, Peru
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Lima, Lima 21, Peru
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Lima, Lima 27, Peru
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Lima, Lima 33, Peru
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Lima, Lima 41, Peru
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Miraflores, Lima 18, Peru
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Piura, 20000, Peru
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Bialystok, 15-003, Poland
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Bialystok, 15-010, Poland
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Bialystok, 15-276, Poland
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Katowice, 40-752, Poland
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Kielce, 25-734, Poland
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Krakow, 31-023, Poland
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Lublin, 20-552, Poland
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Poznan, 60-214, Poland
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Skierniewice, 96-100, Poland
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Tarnów, 33-100, Poland
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Warsaw, 01-868, Poland
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Wroclaw, 54-239, Poland
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Brasov, 16, Romania
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Brasov, 500283, Romania
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Bucharest, 011426, Romania
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Bucharest, 020125, Romania
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Bucharest, 050159, Romania
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Cluj-Napoca, 400349, Romania
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Craiova, 200515, Romania
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Deva, 330084, Romania
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Moscow, 117292, Russia
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S. Petersburg, 194291, Russia
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Saint Petersburg, 193231, Russia
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Saint Petersburg, 194354, Russia
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Smolensk, 214006, Russia
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Dnipro, 49000, Ukraine
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Dnipropetrovsk, 49027, Ukraine
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Dnipropetrovsk, 49066, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kiev, 03680, Ukraine
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Kyiv, 02232, Ukraine
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Kyiv, 03680, Ukraine
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Lviv, 79010, Ukraine
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Odesa, 65114, Ukraine
Related Publications (1)
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.
PMID: 26993628DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 20, 2012
Study Start
April 1, 2012
Primary Completion
May 1, 2014
Study Completion
November 1, 2014
Last Updated
November 2, 2016
Record last verified: 2016-11