A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (CIAS). The study will enroll approximately 308 adult participants with schizophrenia. In addition, the study will evaluate the long-term safety and tolerability of treatment with luvadaxistat. The expected duration of study participation for each participant is approximately 72 weeks.
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.