CYT003, a TLR9 agonist, in persistent allergic asthma - a randomized placebo-controlled Phase 2b study.

摘要: Background New treatment options are required for patients with asthma not sufficiently controlled inhaled therapies. In a Phase 2a trial, CYT003, Toll-like receptor-9 agonist immunomodulator, improved control during glucocorticosteroid reduction in allergic asthma. This double-blind 2b study assessed the efficacy and safety of CYT003 persistent moderate-to-severe on standard therapy with/without long-acting beta-agonists (LABAs). Methods Overall, 365 received seven doses subcutaneous (0.3, 1, or 2 mg) placebo as add-on to conventional controller medication. Change from baseline Asthma Control Questionnaire (ACQ) score was primary outcome; secondary outcomes included change forced expiratory volume, Mini Quality Life Questionnaire, safety. Results All groups, including placebo, showed clinically important improvement ACQ score; however, there no significant difference between groups at week 12 (least-squares mean 0.3 mg: −0.027 [95% confidence interval −0.259 0.204]; 1 mg: 0.097 [−0.131 0.325]; 2 mg: 0.081 [−0.148 0.315]). No differences were seen outcomes. well tolerated; most common treatment-emergent adverse events injection site reactions. Due lack efficacy, prematurely terminated end phase further follow-up. Conclusions Toll-like agonism additional benefit insufficiently receiving without LABAs.