A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis
brief summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
detailed description
This is a 24-week randomized, double-blind, placebo-controlled Phase 2 clinical study with a 28-week extension to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with EoE.
Approximately 180 adult participants with EoE will be randomized at approximately 80 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 24-week treatment period followed by a 28-week extension period. The study also includes a post-treatment follow-up period of 16 weeks.
official title
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study With an Extension to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis (ALAMERE)