A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
This study is currently recruiting participants.
Verified April 2013 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01582503
First received: April 19, 2012
Last updated: April 1, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: MEMP1972A Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Genentech:
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 [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Relative change in pre-bronchodilator FEV1 (volume) [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
- Relative change in FEV1 (volume) [ Time Frame: from baseline to Week 36 ] [ Designated as safety issue: No ]
- Change in asthma symptoms [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
- Change in asthma symptoms [ Time Frame: from baseline to Week 36 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Incidence of anti-therapeutic antibodies (ATAs) [ Time Frame: 84 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre- and post-dose Weeks 0, 4, 12, 24 and 36 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 560 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEMP1972A 300 mg |
Drug: MEMP1972A
Subcutaneous repeating dose
|
| Experimental: MEMP1972A 150 mg |
Drug: MEMP1972A
Subcutaneous repeating dose
|
| Experimental: MEMP1972A 450 mg |
Drug: MEMP1972A
Subcutaneous repeating dose
|
| Placebo Comparator: Placebo |
Drug: placebo
Subcutaneous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582503
Hide Study Locations
Contacts
| Contact: Please reference Study ID Number: GB27980 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Recruiting | |
| Birmingham, Alabama, United States, 35209 | |
| United States, California | |
| Recruiting | |
| Bakersfield, California, United States, 93301 | |
| Recruiting | |
| Costa Mesa, California, United States, 92626 | |
| Recruiting | |
| Fountain Valley, California, United States, 92708 | |
| Recruiting | |
| Long Beach, California, United States, 90808 | |
| Recruiting | |
| Mission Viejo, California, United States, 92691 | |
| Recruiting | |
| Rancho Cordova, California, United States, 95762 | |
| Recruiting | |
| Redwood City, California, United States, 94063 | |
| Recruiting | |
| Riverside, California, United States, 92506 | |
| Recruiting | |
| Stockton, California, United States, 95207 | |
| Recruiting | |
| Torrance, California, United States, 90505 | |
| United States, Colorado | |
| Recruiting | |
| Centennial, Colorado, United States, 80112 | |
| Recruiting | |
| Denver, Colorado, United States, 80206 | |
| United States, Connecticut | |
| Recruiting | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Recruiting | |
| Tampa, Florida, United States, 33613 | |
| Not yet recruiting | |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Recruiting | |
| Albany, Georgia, United States, 31707 | |
| United States, Idaho | |
| Recruiting | |
| Twin Falls, Idaho, United States, 83301 | |
| United States, Illinois | |
| Recruiting | |
| Normal, Illinois, United States, 61761 | |
| Recruiting | |
| River Forest, Illinois, United States, 60305 | |
| United States, Iowa | |
| Recruiting | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Recruiting | |
| Overland Park, Kansas, United States, 66210 | |
| United States, Kentucky | |
| Recruiting | |
| Louisville, Kentucky, United States, 40223 | |
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States, 21236 | |
| United States, Missouri | |
| Recruiting | |
| St Louis, Missouri, United States, 63141 | |
| Recruiting | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Recruiting | |
| Bellevue, Nebraska, United States, 68123 | |
| Recruiting | |
| Omaha, Nebraska, United States, 68130 | |
| United States, New Jersey | |
| Recruiting | |
| Edison, New Jersey, United States, 08820 | |
| Not yet recruiting | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New York | |
| Recruiting | |
| Bronx, New York, United States, 10461 | |
| United States, Ohio | |
| Not yet recruiting | |
| Canton, Ohio, United States, 44718 | |
| Not yet recruiting | |
| Centerville, Ohio, United States, 45458 | |
| Recruiting | |
| Cincinnati, Ohio, United States, 45231 | |
| Not yet recruiting | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Recruiting | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Recruiting | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Recruiting | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Recruiting | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| United States, Rhode Island | |
| Recruiting | |
| Providence, Rhode Island, United States, 02906 | |
| Recruiting | |
| Warwick, Rhode Island, United States, 02865 | |
| United States, South Carolina | |
| Not yet recruiting | |
| Charleston, South Carolina, United States, 29407 | |
| United States, Texas | |
| Recruiting | |
| El Paso, Texas, United States, 79903 | |
| Recruiting | |
| San Antonio, Texas, United States, 78229 | |
| Recruiting | |
| San Antonio, Texas, United States, 78224 | |
| Recruiting | |
| Waco, Texas, United States, 76712 | |
| United States, Utah | |
| Not yet recruiting | |
| Murray, Utah, United States, 84107 | |
| United States, Virginia | |
| Recruiting | |
| Springfield, Virginia, United States, 22152 | |
| United States, Washington | |
| Recruiting | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Recruiting | |
| Greenfield, Wisconsin, United States, 53228 | |
| Argentina | |
| Recruiting | |
| Buenos Aires, Argentina, 1186 | |
| Recruiting | |
| Buenos Aires, Argentina, 1056 | |
| Recruiting | |
| Ciudad Autónoma de Buenos Air, Argentina, C1425BEN | |
| Not yet recruiting | |
| Florencio Varela, Argentina, B1878DVB | |
| Not yet recruiting | |
| Mendoza, Argentina, 5500 | |
| Recruiting | |
| Quilmes, Argentina, 1878 | |
| Recruiting | |
| Rosario, Argentina, 2000 | |
| Recruiting | |
| Salta, Argentina, 4400 | |
| Recruiting | |
| San Miguel de Tucuman, Argentina, 4000 | |
| Not yet recruiting | |
| Tucuman, Argentina, 4000 | |
| Belgium | |
| Recruiting | |
| Halen, Belgium, 3545 | |
| Recruiting | |
| Jambes, Belgium, 5100 | |
| Recruiting | |
| Leuven, Belgium, 3000 | |
| Brazil | |
| Not yet recruiting | |
| Belo Horizonte, Brazil, 30150-221 | |
| Not yet recruiting | |
| Florianopolis, Brazil, 88040-970 | |
| Not yet recruiting | |
| Porto Alegre, Brazil, 90610-000 | |
| Not yet recruiting | |
| Porto Alegre, Brazil, 90020-090 | |
| Not yet recruiting | |
| Porto Alegre, Brazil, 91350-200 | |
| Not yet recruiting | |
| Rio de Janeiro, Brazil, 22280-010 | |
| Not yet recruiting | |
| Rio de Janeiro, Brazil, 20551-030 | |
| Not yet recruiting | |
| Salvador, Brazil, 41940-455 | |
| Not yet recruiting | |
| Santo Andre, Brazil, 09060-050 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 05403-900 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 04023-062 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 05437-010 | |
| Bulgaria | |
| Recruiting | |
| Pleven, Bulgaria, 5800 | |
| Not yet recruiting | |
| Plovdiv, Bulgaria, 4003 | |
| Recruiting | |
| Ruse, Bulgaria, 7002 | |
| Recruiting | |
| Sofia, Bulgaria, 1606 | |
| Recruiting | |
| Sofia, Bulgaria, 1233 | |
| Recruiting | |
| Sofia, Bulgaria, 1431 | |
| Not yet recruiting | |
| Sofia, Bulgaria, 1336 | |
| Not yet recruiting | |
| Sofia, Bulgaria, 1680 | |
| Not yet recruiting | |
| Sofia, Bulgaria, 1431 | |
| Recruiting | |
| Stara Zagora, Bulgaria, 6003 | |
| Recruiting | |
| Varna, Bulgaria, 9010 | |
| Canada, British Columbia | |
| Recruiting | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, Ontario | |
| Recruiting | |
| Mississauga, Ontario, Canada, L5A 3V4 | |
| Recruiting | |
| Ottawa, Ontario, Canada, K1Y 4G2 | |
| Recruiting | |
| Toranto, Ontario, Canada, M5T 3A9 | |
| Recruiting | |
| Toronto, Ontario, Canada, M6H 3M2 | |
| Recruiting | |
| Toronto, Ontario, Canada, M4V 1R2 | |
| Germany | |
| Recruiting | |
| Berlin, Germany, 14050 | |
| Recruiting | |
| Berlin, Germany, 10117 | |
| Recruiting | |
| Bochum, Germany, 44791 | |
| Recruiting | |
| Coswig, Germany, 01640 | |
| Recruiting | |
| Freiburg, Germany, 79106 | |
| Recruiting | |
| Geesthacht, Germany, 21502 | |
| Recruiting | |
| Jena, Germany, 07740 | |
| Recruiting | |
| Landsberg, Germany, 86899 | |
| Recruiting | |
| Magdeburg, Germany, 39120 | |
| Recruiting | |
| Mainz, Germany, 55131 | |
| Recruiting | |
| Muenster, Germany, 48149 | |
| Hungary | |
| Recruiting | |
| Balassagyarmat, Hungary, 2660 | |
| Recruiting | |
| Debrecen, Hungary, 4043 | |
| Recruiting | |
| Mosonmagyaróvar, Hungary, 9200 | |
| Mexico | |
| Recruiting | |
| Guadalajara, Mexico, 44130 | |
| Recruiting | |
| Mexico, Mexico, 03100 | |
| Recruiting | |
| Nuevo Leon, Mexico, 64710 | |
| New Zealand | |
| Recruiting | |
| Auckland, New Zealand, 1023 | |
| Recruiting | |
| Auckland, New Zealand, 2025 | |
| Recruiting | |
| Christchurch, New Zealand, 8011 | |
| Recruiting | |
| Dunedin, New Zealand | |
| Recruiting | |
| Hamilton, New Zealand | |
| Recruiting | |
| Wellington, New Zealand | |
| Peru | |
| Not yet recruiting | |
| Lima, Peru, Lima 21 | |
| Not yet recruiting | |
| Lima, Peru, Lima 41 | |
| Not yet recruiting | |
| Lima, Peru, Lima 07 | |
| Not yet recruiting | |
| Lima, Peru, Lima 33 | |
| Not yet recruiting | |
| Lima, Peru, 31 | |
| Not yet recruiting | |
| Lima, Peru, Lima 27 | |
| Not yet recruiting | |
| Lima, Peru, LIMA 29 | |
| Not yet recruiting | |
| Lima, Peru, Lima 1 | |
| Not yet recruiting | |
| Miraflores, Peru, Lima 18 | |
| Not yet recruiting | |
| Piura, Peru | |
| Poland | |
| Recruiting | |
| Bialystok, Poland, 15-003 | |
| Recruiting | |
| Bialystok, Poland, 15-950 | |
| Recruiting | |
| Bialystok, Poland, 15-010 | |
| Recruiting | |
| Katowice, Poland, 40-752 | |
| Recruiting | |
| Kielce, Poland, 25-734 | |
| Recruiting | |
| Krakow, Poland, 31-023 | |
| Recruiting | |
| Lublin, Poland, 20-552 | |
| Recruiting | |
| Poznan, Poland, 60-214 | |
| Recruiting | |
| Skierniewice, Poland, 96-100 | |
| Recruiting | |
| Tarnow, Poland, 33-100 | |
| Recruiting | |
| Warszawa, Poland, 01-868 | |
| Recruiting | |
| Wroclaw, Poland, 54-239 | |
| Romania | |
| Recruiting | |
| Brasov, Romania, 500283 | |
| Recruiting | |
| Brasov, Romania, 16 | |
| Recruiting | |
| Bucharest, Romania, 050159 | |
| Recruiting | |
| Bucuresti, Romania, 011426 | |
| Recruiting | |
| Bucuresti, Romania, 020125 | |
| Recruiting | |
| Cluj-napoca, Romania, 400349 | |
| Recruiting | |
| Craiova, Romania, 200515 | |
| Recruiting | |
| Deva, Romania, 330084 | |
| Russian Federation | |
| Recruiting | |
| Moscow, Russian Federation, 117292 | |
| Recruiting | |
| S. Petersburg, Russian Federation, 195067 | |
| Recruiting | |
| Smolensk, Russian Federation, 214006 | |
| Recruiting | |
| St Petersburg, Russian Federation, 193231 | |
| Recruiting | |
| St. Petersburg, Russian Federation, 194354 | |
| Ukraine | |
| Not yet recruiting | |
| Dnepropetrovsk, Ukraine, 49071 | |
| Recruiting | |
| Dnipropetrovsk, Ukraine, 49066 | |
| Not yet recruiting | |
| Ivano-frankivsk, Ukraine, 76018 | |
| Not yet recruiting | |
| Kiev, Ukraine, 03680 | |
| Not yet recruiting | |
| Kyiv, Ukraine, 03680 | |
| Not yet recruiting | |
| Kyiv, Ukraine, 02232 | |
| Not yet recruiting | |
| Lviv, Ukraine, 79010 | |
| Not yet recruiting | |
| Odessa, Ukraine, 65114 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01582503 History of Changes |
| Other Study ID Numbers: | GB27980, 2011-003997-10 |
| Study First Received: | April 19, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013