NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis
brief summary
This Phase 2a study will evaluate the safety and efficacy of nogapendekin alfa inbakicept (NAI) plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia. Participants will be randomized approximately 1:1 and treated under double-blind conditions. The study includes a safety run-in for the first 10 randomized participants, followed by enrollment of the remaining participants after safety review. Outcomes include safety, 28-day survival, absolute lymphocyte count recovery, organ-support-free status, organ dysfunction, and ICU and hospital outcomes
detailed description
This is a randomized, double-blind, placebo-controlled, parallel-assignment Phase 2a study evaluating NAI plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia. Approximately 50 participants will be randomized in a 1:1 ratio. The first 10 randomized participants will comprise a safety run-in, with approximately 5 participants assigned to each treatment arm. Safety data will be reviewed by the designated safety review committee or DSMB before enrollment of the remaining participants proceeds.
official title
Phase 2a, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Safety and Efficacy of Nogapendekin Alfa Inbakicept (NAI) Plus Standard of Care (SOC) Compared to SOC Alone in Critically Ill Adults With Sepsis