Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003997-10 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEMP1972A 150 mg | Experimental |
| |
| MEMP1972A 300 mg | Experimental |
| |
| MEMP1972A 450 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEMP1972A | Drug | Subcutaneous repeating dose |
| |
| MEMP1972A |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35209 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26993628 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Subcutaneous repeating dose |
|
| MEMP1972A | Drug | Subcutaneous repeating dose |
|
| placebo | Drug | Subcutaneous repeating dose |
|
| 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 |
| Safety: Incidence of adverse events | 48 weeks |
| Incidence of anti-therapeutic antibodies (ATAs) | 84 weeks |
| Pharmacokinetics: Area under the concentration-time curve (AUC) | Pre- and post-dose Weeks 0, 4, 12, 24 and 36 |
| Bakersfield |
| California |
| 93301 |
| United States |
| Costa Mesa | California | 92626 | United States |
| Fountain Valley | California | 92708 | United States |
| Long Beach | California | 90808 | United States |
| Mission Viejo | California | 92691 | United States |
| Rancho Cordova | California | 95762 | United States |
| Redwood City | California | 94063 | United States |
| Stockton | California | 95207 | United States |
| Torrance | California | 90505 | United States |
| Upland | California | 91786 | United States |
| Centennial | Colorado | 80112 | United States |
| Denver | Colorado | 80206 | United States |
| New Haven | Connecticut | 06510 | United States |
| Tampa | Florida | 33613 | United States |
| Winter Park | Florida | 32789 | United States |
| Albany | Georgia | 31707 | United States |
| Twin Falls | Idaho | 83301 | United States |
| Normal | Illinois | 61761 | United States |
| River Forest | Illinois | 60305 | United States |
| Iowa City | Iowa | 52242 | United States |
| Overland Park | Kansas | 66210 | United States |
| Louisville | Kentucky | 40223 | United States |
| Baltimore | Maryland | 21236 | United States |
| St Louis | Missouri | 63141 | United States |
| Bellevue | Nebraska | 68123 | United States |
| Omaha | Nebraska | 68130 | United States |
| Edison | New Jersey | 08820 | United States |
| Teaneck | New Jersey | 07666 | United States |
| The Bronx | New York | 10461 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Canton | Ohio | 44718 | United States |
| Centerville | Ohio | 45458 | United States |
| Cincinnati | Ohio | 45231 | United States |
| Oklahoma City | Oklahoma | 73120 | United States |
| Tulsa | Oklahoma | 74136 | United States |
| Medford | Oregon | 97504 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Providence | Rhode Island | 02906 | United States |
| Warwick | Rhode Island | 02865 | United States |
| Charleston | South Carolina | 29407 | United States |
| El Paso | Texas | 79903 | United States |
| El Paso | Texas | 79925 | United States |
| San Antonio | Texas | 78224 | United States |
| San Antonio | Texas | 78229 | United States |
| Waco | Texas | 76712 | United States |
| Murray | Utah | 84107 | United States |
| Fairfax | Virginia | 22030 | United States |
| Spokane | Washington | 99204 | United States |
| Greenfield | Wisconsin | 53228 | United States |
| Buenos Aires | 1056 | Argentina |
| Buenos Aires | 1186 | Argentina |
| Buenos Aires | C1425BEN | Argentina |
| Mendoza | 5500 | Argentina |
| Quilmes | 1878 | Argentina |
| Rosario | 2000 | Argentina |
| Salta | 4400 | Argentina |
| San Juan Bautista | 1888 | Argentina |
| San Miguel de Tucumán | 4000 | Argentina |
| Gembloux | 5030 | Belgium |
| Halen | 3545 | Belgium |
| Leuven | 3000 | Belgium |
| Pleven | 5800 | Bulgaria |
| Plovdiv | 4003 | Bulgaria |
| Rousse | 7002 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1336 | Bulgaria |
| Sofia | 1431 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Sofia | 1680 | Bulgaria |
| Stara Zagora | 6003 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Mississauga | Ontario | L5A 3V4 | Canada |
| Ottawa | Ontario | K1Y 4G2 | Canada |
| Toronto | Ontario | M4V 1R2 | Canada |
| Toronto | Ontario | M5T 3A9 | Canada |
| Toronto | Ontario | M6H 3M2 | Canada |
| Berlin | 10117 | Germany |
| Berlin | 14050 | Germany |
| Bochum | 44789 | Germany |
| Coswig | 01640 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Geesthacht | 21502 | Germany |
| Jena | 07740 | Germany |
| Landsberg | 86899 | Germany |
| Magdeburg | 39120 | Germany |
| Mainz | 55131 | Germany |
| Münster | 48149 | Germany |
| Balassagyarmat | 2660 | Hungary |
| Debrecen | 4031 | Hungary |
| Mosonmagyaróvar | 9200 | Hungary |
| Guadalajara | 44130 | Mexico |
| México | 03100 | Mexico |
| Nuevo León | 64710 | Mexico |
| Auckland | 1023 | New Zealand |
| Aucklund | 2025 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Dunedin | New Zealand |
| Hamilton | New Zealand |
| Wellington | New Zealand |
| Lima | 31 | Peru |
| Lima | Lima 07 | Peru |
| Lima | Lima 1 | Peru |
| Lima | Lima 21 | Peru |
| Lima | Lima 27 | Peru |
| Lima | Lima 33 | Peru |
| Lima | Lima 41 | Peru |
| Miraflores | Lima 18 | Peru |
| Piura | 20000 | Peru |
| Bialystok | 15-003 | Poland |
| Bialystok | 15-010 | Poland |
| Bialystok | 15-276 | Poland |
| Katowice | 40-752 | Poland |
| Kielce | 25-734 | Poland |
| Krakow | 31-023 | Poland |
| Lublin | 20-552 | Poland |
| Poznan | 60-214 | Poland |
| Skierniewice | 96-100 | Poland |
| Tarnów | 33-100 | Poland |
| Warsaw | 01-868 | Poland |
| Wroclaw | 54-239 | Poland |
| Brasov | 16 | Romania |
| Brasov | 500283 | Romania |
| Bucharest | 011426 | Romania |
| Bucharest | 020125 | Romania |
| Bucharest | 050159 | Romania |
| Cluj-Napoca | 400349 | Romania |
| Craiova | 200515 | Romania |
| Deva | 330084 | Romania |
| Moscow | 117292 | Russia |
| S. Petersburg | 194291 | Russia |
| Saint Petersburg | 193231 | Russia |
| Saint Petersburg | 194354 | Russia |
| Smolensk | 214006 | Russia |
| Dnipro | 49000 | Ukraine |
| Dnipropetrovsk | 49027 | Ukraine |
| Dnipropetrovsk | 49066 | Ukraine |
| Ivano-Frankivsk | 76018 | Ukraine |
| Kiev | 03680 | Ukraine |
| Kyiv | 02232 | Ukraine |
| Kyiv | 03680 | Ukraine |
| Lviv | 79010 | Ukraine |
| Odesa | 65114 | Ukraine |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided