Tralokinumab: Phase IIb data

A double-blind, international Phase IIb trial in 452 patients with uncontrolled, severe asthma showed that subcutaneous tralokinumab every 2 weeks and subcutaneous tralokinumab every 2 weeks for 12 weeks followed by every 4 weeks each missed the primary endpoint of reducing asthma exacerbation rate from baseline to week 53 vs. placebo. Tralokinumab every 2 weeks met the secondary endpoints of improving FEV1 (difference from placebo of 7.1%, p=0.003), ACQ-6 score (difference from placebo of 0.18 points, p=0.137) and AQLQ score (difference from placebo of 0.21 points, p=0.114) from baseline to week 53 vs. placebo. The threshold for significance was p=0.15. ...