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

NCT ID: NCT05227703

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 391 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2024-09-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CVL-231 15 mg, once daily (QD)

Oral Dose

Group Type: EXPERIMENTAL

Emraclidine 15 mg

Intervention Type: DRUG

Emraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks

CVL-231 30 mg, once daily (QD)

Oral Dose

Group Type: EXPERIMENTAL

Emraclidine 30 mg

Intervention Type: DRUG

Emraclidine 30 mg, oral (tablet), QD for 6 weeks

Placebo, once daily (QD)

Oral Dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo, oral (tablet), QD for 6 weeks

Interventions

Emraclidine 15 mg

Emraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks

Intervention Type: DRUG

Emraclidine 30 mg

Emraclidine 30 mg, oral (tablet), QD for 6 weeks

Intervention Type: DRUG

Placebo

Matching placebo, oral (tablet), QD for 6 weeks

Intervention Type: DRUG

Other Intervention Names

CVL-231; ABBV-1231; CVL-231; ABBV-1231

Eligibility Criteria

Inclusion Criteria

• Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders.
• CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline.
• PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline.
• Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF.
• Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
• Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs).
• Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.

Exclusion Criteria

• Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed); Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory. Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory.
• Any of the following:

• Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks)
• History of response to clozapine treatment only or failure to respond to clozapine treatment
• Any of the following regarding history of schizophrenia:

• Time from initial onset of schizophrenia <2 years based on prior records or participant self-report
• Presenting with an initial diagnosis of schizophrenia
• Presenting for the first time with an acute psychotic episode requiring treatment
• Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline.
• Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
• Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results
• Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF.
• Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment.
• Any condition that could possibly affect drug absorption.
• Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial.
• Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening.
• Positive pregnancy test result prior to receiving IMP. Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP are also excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Adams

Role: STUDY_DIRECTOR

AbbVie

Locations

Bentonville, Arkansas

Bentonville, Arkansas, United States

Bellflower, California

Bellflower, California, United States

La Habra, California

La Habra, California, United States

San Diego, California

San Diego, California, United States

Sherman Oaks, California

Sherman Oaks, California, United States

Torrance, California

Torrance, California, United States

New Haven, Connecticut

New Haven, Connecticut, United States

Homestead, Florida

Homestead, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami Lakes, Florida

Miami Lakes, Florida, United States

Miami Springs, Florida

Miami Springs, Florida, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Savannah, Georgia

Savannah, Georgia, United States

Chicago, Illinois

Chicago, Illinois, United States

Chicago, Illinois

Chicago, Illinois, United States

Berlin, New Jersey

Berlin, New Jersey, United States

Marlton, New Jersey

Marlton, New Jersey, United States

Charlotte, North Carolina

Charlotte, North Carolina, United States

Austin, Texas

Austin, Texas, United States

Sofia, Sofia-Grad

Sofia, Sofia-Grad, Bulgaria

Burgas, Burgas

Burgas, , Bulgaria

Pleven, Pleven

Pleven, , Bulgaria

Sofia, Sofia

Sofia, , Bulgaria

Kalocsa, Bács-Kiskun

Kalocsa, Bács-Kiskun county, Hungary

Győr, Győr-Moson-Sopron

Győr, Győr-Moson-Sopron, Hungary

Budapest, Budapest

Budapest, , Hungary

Countries

United States; Bulgaria; Hungary

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CVL-231-2002

Identifier Type: -

Identifier Source: org_study_id