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A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 317 75 mg | Experimental | 75 subjects |
|
| Placebo Arm | Placebo Comparator | 75 subjects |
|
| AMG 317 300 mg | Experimental | 75 subjects |
|
| AMG 317 150 mg | Experimental | 75 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 317 75 mg | Biological | 75 mg SC weekly injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in frequency of rescue beta agonist use during week 12 | 12 weeks | |
| Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation) | 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21093024 | Derived | Meltzer EO, Busse WW, Wenzel SE, Belozeroff V, Weng HH, Feng J, Chon Y, Chiou CF, Globe D, Lin SL. Use of the Asthma Control Questionnaire to predict future risk of asthma exacerbation. J Allergy Clin Immunol. 2011 Jan;127(1):167-72. doi: 10.1016/j.jaci.2010.08.042. Epub 2010 Nov 18. | |
| 20056900 | Derived | Corren J, Busse W, Meltzer EO, Mansfield L, Bensch G, Fahrenholz J, Wenzel SE, Chon Y, Dunn M, Weng HH, Lin SL. A randomized, controlled, phase 2 study of AMG 317, an IL-4Ralpha antagonist, in patients with asthma. Am J Respir Crit Care Med. 2010 Apr 15;181(8):788-96. doi: 10.1164/rccm.200909-1448OC. Epub 2010 Jan 7. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C549611 | AMG 317 |
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| AMG 317 150 mg |
| Biological |
150 mg SC once weekly injection |
|
|
| AMG 317 300 mg | Biological | 300 mg weekly SC injection |
|
| Placebo | Biological | Placebo SC once weekly injection |
|
| Change in pre and post bronchodilator FEV1 at week 12 from baseline |
| 12 weeks |
| Number of asthma symptom-free days | 16 weeks |
| Change from baseline in daily asthma symptoms during week 12 | 12 weeks |
| Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs | 16 weeks |
| Change in AQLQ score at week 12 from baseline | 12 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |