NCT05227703

A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia

A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (15 mg and 30 mg QD) of CVL-231 (Emraclidine) in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 391 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (15 mg QD and 30 mg QD) in male and female adult participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.

Detailed description

The trial included up to a 15-day Screening Period (up to a maximum of 21 days allowed with approval of the medical monitor), a 45-day Inpatient Treatment Period, and a 28-day Follow-up Period. Each participant participated in the trial for up to approximately 13 weeks.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Emraclidine 15 mg	Emraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks
DRUG	Emraclidine 30 mg	Emraclidine 30 mg, oral (tablet), QD for 6 weeks
DRUG	Placebo	Matching placebo, oral (tablet), QD for 6 weeks

Timeline

• Start date: 2022-07-05
• Primary completion: 2024-08-15
• Completion: 2024-09-11
• First posted: 2022-02-07
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

26 sites across 3 countries: United States, Bulgaria, Hungary

Regulatory

• FDA-regulated drug study