The LAVOLTA I-II studies were identical, double-blind, randomized, multi-center, placebo-controlled studies designed to evaluate the efficacy and safety of lebrikizumab – a novel humanized monoclonal antibody designed to treat severe asthma.
Together, the studies included more than 2,100 people across 28 countries.
According to the company’s recent release, one study met its primary endpoint (showing lebrikizumab significantly reduced exacerbations in people with severe asthma); however, the second study did not meet statistical significance.
“It is too early to determine why the results of the LAVOLTA I study and LAVOLTA II study are different,” a Roche spokesperson told Outsourcing-Pharma.com.
The conflicting results highlight the difficulties faced in clinical trials. As such, the company plans on submitting the results for presentation at forthcoming medical meetings after analyzing the data to better understand the results.
“We were hopeful these identical studies would confirm the phase II results because there is still a significant unmet need for people with severe asthma,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development at Roche.
“These data require further interpretation and analyses are ongoing to better understand the results and determine next steps.”