A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NBI-1117570 in Hospitalized Adults with Schizophrenia

The primary objective is to evaluate the efficacy of NBI-1117570 compared to placebo in improving behavioral and psychological symptoms in adults diagnosed with schizophrenia who require inpatient hospitalization. Secondary objectives include the assessment of:

• Safety and tolerability of NBI-1117570.
• Pharmacokinetics of the investigational product.

This clinical trial involves a total of 96 participants diagnosed with schizophrenia. The study population consists of adults, including both male and female subjects, who require inpatient hospitalization. Eligible participants are aged between 18 and 55 years and must have a primary diagnosis established at least one year prior to screening. Inclusion requires the presence of an acute exacerbation or relapse of symptoms with an onset occurring less than two months before screening. Furthermore, subjects must have demonstrated a positive response to at least one antipsychotic therapy, excluding clozapine, during a previous acute relapse treatment.

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-1117570 in adults diagnosed with schizophrenia who require inpatient hospitalization. The primary objective is to evaluate changes from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to a placebo. The study involves an initial screening period to identify eligible participants, followed by the administration of the investigational product in capsule form via oral use. The trial is scheduled to occur between February 2026 and August 2027.

The experimental medication is NBI-1117570, which is administered in a capsule pharmaceutical form. The substance is intended for oral use.

The study utilizes a placebo for comparison against the test substance.

The efficacy of NBI-1117570 will be evaluated in adults diagnosed with schizophrenia requiring inpatient hospitalization. The primary endpoint is the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score, which serves to quantify the severity of psychiatric symptoms.