A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia

NCT05227690 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CVL-231-20012022-000580-52
• Study Type: interventional
• Target: 385
• Locations: 2 countries
• Sites: 25

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) (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

Keywords

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

  Baseline through Week 6

Secondary Outcomes (13)

• Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)

  Baseline through Week 6

• Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score

  Baseline; Weeks 1, 2, 3, 4, 5, and 6

• Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score

  Baseline; Weeks 1, 2, 3, 4, 5, and 6

• Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in Positive and Negative Syndrome Scale [PANSS] Total Score)

  Baseline through Week 6

• Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

  From first dose of study drug until 28 days following last dose of study drug (up to Week 10)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.

Drug: Placebo

Emraclidine 10 mg, once daily (QD)

EXPERIMENTAL

Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.

Drug: Emraclidine 10 mg

Emraclidine 30 mg, once daily (QD)

EXPERIMENTAL

Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Drug: Emraclidine 30 mg

Interventions

Placebo DRUG

Matching placebo, oral (tablet), once per day for 6 weeks

Placebo

Emraclidine 10 mg DRUG

Emraclidine 10 mg, oral (tablet), once per day for 6 weeks

Also known as: CVL-231, ABBV-1231

Emraclidine 10 mg, once daily (QD)

Emraclidine 30 mg DRUG

Emraclidine 30 mg, oral (tablet), once per day for 6 weeks

Also known as: CVL-231, ABBV-1231

Emraclidine 30 mg, once daily (QD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (25)

Little Rock, Arkansas

Little Rock, Arkansas, 72211-3702, United States

Location

Anaheim, California

Anaheim, California, 92805-5854, United States

Location

Garden Grove, California

Garden Grove, California, 92845-2506, United States

Location

Lemon Grove, California

Lemon Grove, California, 91945-2956, United States

Location

Montclair, California

Montclair, California, 91763-2231, United States

Location

Riverside, California

Riverside, California, 92506-3257, United States

Location

San Diego, California

San Diego, California, 92123, United States

Location

Hialeah, Florida

Hialeah, Florida, 33012-4648, United States

Location

Hollywood, Florida

Hollywood, Florida, 33021-5414, United States

Location

Mangonia Park, Florida

Mangonia Park, Florida, 33407-2413, United States

Location

Oakland Park, Florida

Oakland Park, Florida, 33334-4135, United States

Location

Atlanta, Georgia

Atlanta, Georgia, 30328-4018, United States

Location

Decatur, Georgia

Decatur, Georgia, 30030-3438, United States

Location

Shreveport, Louisiana

Shreveport, Louisiana, 71101-4603, United States

Location

Gaithersburg, Maryland

Gaithersburg, Maryland, 20877-1409, United States

Location

Flowood, Mississippi

Flowood, Mississippi, 39232-8016, United States

Location

North Canton, Ohio

North Canton, Ohio, 44720, United States

Location

DeSoto, Texas

DeSoto, Texas, 75115-2092, United States

Location

Houston, Texas

Houston, Texas, 77043-2735, United States

Location

Irving, Texas

Irving, Texas, 75062-2323, United States

Location

Richardson, Texas

Richardson, Texas, 75080, United States

Location

Stara Zagora

Stara Zagora, 6003, Bulgaria

Location

Veliko Tarnovo

Veliko Tarnovo, 5000, Bulgaria

Location

Veliko Tarnovo, Veliko Tarnovo

Veliko Tarnovo, 5047, Bulgaria

Location

Vratsa, Vratsa

Vratsa, 3000, Bulgaria

Location

MeSH Terms

Conditions

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: June 30, 2022
• Primary Completion: August 23, 2024
• Study Completion: August 26, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-09

Locations

US (21); BU (4)