Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GA01332 | Other Identifier | Hoffmann-La Roche |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients by intravenous (IV) infusion for the treatment of allergen-induced asthma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEMP1972A | Drug | Intravenous repeating dose |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time) | Between 3 and 7 hours after allergen challenge at Day 86 after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum percent decline in FEV1 | Immediately prior to the allergen challenge to between 3 and 7 hours after allergen challenge on Day 86 after the first dose | |
| Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20 | Day 87 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Harris, MD, Ph.D | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary | Alberta | T2N 4Z6 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24990880 | Derived | Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlen B, Wang Y, Maciuca R, Mayers I, Liao XC, Wu LC, Matthews JG, O'Byrne PM. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med. 2014 Jul 2;6(243):243ra85. doi: 10.1126/scitranslmed.3008961. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Intravenous repeating dose |
|
| Maximum percent decline in FEV1 and early airway response (EAR) AUC (percent decline in FEV1 over time) | Between 0 and 3 hours after post-treatment allergen challenge |
| Edmonton |
| Alberta |
| T6G1Z1 |
| Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Hamilton | Ontario | L8N 3Z5 | Canada |
| Ste. Foy | Quebec | G1V 4G5 | Canada |
| Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Stockholm | S-14186 | Sweden |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |