Phase 2b study of lumicitabine in infants and children hospitalized with RSV (Study 2)
RSV INFECTION
Study 2 was a randomized, double-blind, placebo-controlled, phase 2b study conducted in infants and children (aged 28 days to 36 months) hospitalized with RSV infection. The study consisted of the screening phase and the treatment phase. The initial LD on day 1 was followed by 9 MDs after 8-16 hours, each administered twice-daily (i.e., 5-day treatment duration). The follow-up phase ended 28 days post-randomization. Study 2 was initiated prior to the completion of Study 1. The dose regimen in Study 2 was influenced by the number of patients who were treated with the lumicitabine 40/20 mg/kg LD/ MD in Study 1, and the IDMC recommendations. In Study 2, infants/children were randomized (1:1:1) to receive either the 40/20 mg/kg LD/MD regimen, the 60/40 mg/kg LD/MD regimen, or lumicitabine-matched placebo. An unblinded IDMC planned to initially review the safety and PK data after the first 12 infants; this was to be repeated after 30 infants had completed treatment, to assess for the safe enrollment of additional patients in each arm.In February 2018, further enrollment was voluntarily halted by the sponsor. On 17 October 2018, the study was terminated prematurely by the sponsor as a precautionary measure, to allow further evaluation and assessment of new nonclinical PK and safety findings and determine their relevance to the study in humans.The study protocols (