drugset / Trial / NCT00436670
Phase II Study to Evaluate the Efficacy of AMG 317
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-09
- Completion
- 2009-02
Outcome
Missed primary endpoint
paper treatment effect P = 0.25 PMID 20056900 ↗
paper AMG 317 did not demonstrate clinical efficacy across the overall group of patients. PMID 20056900 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMG 317 | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | AMG 317 | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | AMG 317 | Monoclonal antibody | 300 mg | Subcutaneous |