NCT05227690

A Trial of 10 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 (10 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: 385 (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) (10 mg QD and 30 mg QD) in male and female participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo, oral (tablet), once per day for 6 weeks
DRUG	Emraclidine 10 mg	Emraclidine 10 mg, oral (tablet), once per day for 6 weeks
DRUG	Emraclidine 30 mg	Emraclidine 30 mg, oral (tablet), once per day for 6 weeks

Timeline

• Start date: 2022-06-30
• Primary completion: 2024-08-23
• Completion: 2024-08-26
• First posted: 2022-02-07
• Last updated: 2025-09-17
• Results posted: 2025-09-17

Locations

25 sites across 2 countries: United States, Bulgaria

Regulatory

• FDA-regulated drug study