A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults
Summary
To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.
Timeline
- Start
- 2009-12
- Primary completion
- 2011-11
- Completion
- 2012-01
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs MEDI528 30 mg; p = 0.435; ANOVA NCT00968669 ↗
registry analysis (superiority or other test); Placebo vs MEDI528 100 mg; p = 0.828; ANOVA NCT00968669 ↗
registry analysis (superiority or other test); MEDI528 300 mg; p = 0.628; ANOVA NCT00968669 ↗
paper Mean (SD) change from baseline to week 13 in ACQ-6 scores for placebo vs combined MEDI-528 groups was -1.2 (1.0) vs -1.2 (1.1) (p = 0.86). PMID 24050312 ↗
paper The addition of MEDI-528 to existing asthma controller medications was not associated with any improvement in ACQ-6 scores PMID 24050312 ↗
Publications
- Oh CK, Leigh R, McLaurin KK, Kim K, Hultquist M, Molfino NA. A randomized, controlled trial to evaluate the effect of an anti-interleukin-9 monoclonal antibody in adults with uncontrolled asthma. Respir Res. 2013 Sep 19;14(1):93. doi: 10.1186/1465-9921-14-93.
- Lloyd CM, Hessel EM. Functions of T cells in asthma: more than just T(H)2 cells. Nat Rev Immunol. 2010 Dec;10(12):838-48. doi: 10.1038/nri2870. Epub 2010 Nov 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ENOKIZUMAB | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | ENOKIZUMAB | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | ENOKIZUMAB | Monoclonal antibody | 300 mg | Subcutaneous |