A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

NCT05443724 | Completed Phase 2 FDA Drug

• 2 other identifiers: CVL-231-20032022-001151-16
• Study Type: interventional
• Target: 700
• Locations: 5 countries
• Sites: 85

Brief Summary

The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (11)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to Week 56

• Number of Participants With Clinically Significant Changes in Vital Sign Values

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Body Weight

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Clinical Laboratory Values

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Metabolic Parameter Values

  Up to Week 52

• Number of Participants With Clinically Significant Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score

  Up to Week 52

• Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score

  Baseline up to Week 52

• Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score

  Baseline up to Week 52

• Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score

  Baseline up to Week 52

Study Arms (1)

CVL-231 30 mg

EXPERIMENTAL

Participants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks.

Drug: CVL-231 30 mg

Interventions

CVL-231 30 mg DRUG

Oral tablets

Also known as: Emraclidine

CVL-231 30 mg

Eligibility Criteria

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

You may qualify if:

• Completed 6 weeks of post-randomization treatment in Trial CVL-231-2001 (NCT05227690) or CVL-231-2002 (NCT05227703) and who, in the opinion of the investigator, could potentially benefit from treatment with emraclidine for schizophrenia.
• Primary diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as confirmed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders.
• Participants who have been stable on antipsychotic medication for at least one 3-month in the year prior to screening.
• Outpatient status at the time of signing the informed consent form informed consent form (ICF).
• Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
• Ability, in the investigator's opinion, 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 is 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.
• 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 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 C-SSRS and investigator's clinical assessment.
• Any condition that could possibly affect drug absorption, including, but not limited to bowel resections, bariatric weight loss surgery, gastric banding, and gastrectomy
• 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 investigational medicinal product (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 the IMP are also excluded.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (85)

Phoenix, Arizona

Phoenix, Arizona, 85012-2707, United States

Location

Bryant, Arkansas

Bryant, Arkansas, 72022-9252, United States

Location

Little Rock, Arkansas

Little Rock, Arkansas, 72211-3702, United States

Location

Anaheim, California

Anaheim, California, 92805-5854, United States

Location

Bellflower, California

Bellflower, California, 90706-7079, United States

Location

Culver City, California

Culver City, California, 90230-6632, United States

Location

Garden Grove, California

Garden Grove, California, 92845-2506, United States

Location

La Habra, California

La Habra, California, 90631-3842, United States

Location

Lemon Grove, California

Lemon Grove, California, 91945-2956, United States

Location

Montclair, California

Montclair, California, 91763-2231, United States

Location

Orange,California

Orange, California, 92868-4447, United States

Location

Pico Rivera, California

Pico Rivera, California, 90660-4920, United States

Location

Riverside, California

Riverside, California, 92506-3237, United States

Location

San Diego, California

San Diego, California, 92103-2209, United States

Location

San Diego, California

San Diego, California, 92121, United States

Location

San Diego, California

San Diego, California, 92123, United States

Location

Sherman Oaks, California

Sherman Oaks, California, 91403-1747, United States

Location

Torrance, California

Torrance, California, 90502-4432, United States

Location

Walnut Creek, California

Walnut Creek, California, 94549, United States

Location

New Haven, Connecticut

New Haven, Connecticut, 06519-1109, United States

Location

Bonita Springs,Florida

Bonita Springs, Florida, 34134-4154, United States

Location

Fort Myers, Florida

Fort Myers, Florida, 33901-3711, United States

Location

Hialeah, Florida

Hialeah, Florida, 33012-4648, United States

Location

Hialeah, Florida

Hialeah, Florida, 33016-1814, United States

Location

Miami, Florida

Miami, Florida, 33122-1335, United States

Location

Miami, Florida

Miami, Florida, 33125-5114, United States

Location

Miami, Florida

Miami, Florida, 33155, United States

Location

Miami Lakes, Florida

Miami Lakes, Florida, 33016-1553, United States

Location

Miami Lakes, Florida

Miami Lakes, Florida, 33016, United States

Location

Miami Springs, Florida

Miami Springs, Florida, 33166-7225, United States

Location

Oakland Park, Florida

Oakland Park, Florida, 33334-4135, United States

Location

West Palm Beach, Florida

West Palm Beach, Florida, 33407-2015, United States

Location

Atlanta, Georgia

Atlanta, Georgia, 30318-3102, United States

Location

Atlanta, Georgia

Atlanta, Georgia, 30328-4018, United States

Location

Atlanta, Georgia

Atlanta, Georgia, 30331, United States

Location

Decatur, Georgia

Decatur, Georgia, 30030-3438, United States

Location

Savannah,Georgia

Savannah, Georgia, 31405-5702, United States

Location

Berwyn, Illinois

Berwyn, Illinois, 60402-2248, United States

Location

Chicago, Illinois

Chicago, Illinois, 60611-3478, United States

Location

Chicago, Illinois

Chicago, Illinois, 60622-1702, United States

Location

Chicago, Illinois

Chicago, Illinois, 60623, United States

Location

Chicago, Illinois

Chicago, Illinois, 60640-5017, United States

Location

Chicago, Illinois

Chicago, Illinois, 60641-4023, United States

Location

Marrero, Louisiana

Marrero, Louisiana, 70072-3083, 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

Las Vegas, Nevada

Las Vegas, Nevada, 89102-1972, United States

Location

Berlin, New Jersey

Berlin, New Jersey, 08009, United States

Location

Cedarhurst, New York

Cedarhurst, New York, 11516-1905, United States

Location

New York, New York

New York, New York, 10036-4811, United States

Location

Staten Island, New York

Staten Island, New York, 10314-1607, United States

Location

Charlotte, North Carolina

Charlotte, North Carolina, 28211-4849, United States

Location

North Canton, Ohio

North Canton, Ohio, 44718-2567, United States

Location

Oklahoma City, Oklahoma

Oklahoma City, Oklahoma, 73102-1018, United States

Location

Franklin,Tennessee

Franklin, Tennessee, 37067-5967, United States

Location

Austin, Texas

Austin, Texas, 78754-5122, United States

Location

DeSoto, Texas

DeSoto, Texas, 75115-2066, United States

Location

Houston, Texas

Houston, Texas, 77043, United States

Location

Houston, Texas

Houston, Texas, 77074, United States

Location

Plano, Texas

Plano, Texas, 75093-0010, United States

Location

Richardson, Texas

Richardson, Texas, 75080-3764, United States

Location

Sofia, Sofia-Grad

Sofia, Sofia-Grad, 1202, Bulgaria

Location

Sofia, Sofia-Grad

Sofia, Sofia-Grad, 1407, Bulgaria

Location

Sofia, Sofia-Grad

Sofia, Sofia-Grad, 1431, Bulgaria

Location

Sofia, Sofia-Grad

Sofia, Sofia-Grad, 1510, Bulgaria

Location

Sofia, Sofia-Grad

Sofia, Sofia-Grad, 1606, Bulgaria

Location

Sofia, Sofia-Grad

Sofia, Sofia-Grad, 1680, Bulgaria

Location

Pazardzhik, Pazardzhik

Pazardzhik, 4400, Bulgaria

Location

Pleven, Pleven

Pleven, 5800, Bulgaria

Location

Sliven, Sliven

Sliven, 8800, Bulgaria

Location

Stara Zagora, Stara Zagora

Stara Zagora, 6003, Bulgaria

Location

Varna, Varna

Varna, 9000, Bulgaria

Location

Veliko Tarnovo, Veliko Tarnovo

Veliko Tarnovo, 5000, Bulgaria

Location

Vratsa, Vratsa

Vratsa, 3000, Bulgaria

Location

Kalocsa, Bács-Kiskun

Kalocsa, Bács-Kiskun county, 6300, Hungary

Location

Gyor, Gyor-Moson-Sopron

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

San Juan, Puerto Rico

San Juan, 918, Puerto Rico

Location

San Juan, Puerto Rico

San Juan, 926, Puerto Rico

Location

Ivano Frankivsk, Ivano Frankivsk

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76011, Ukraine

Location

Lviv, L'vivs'ka Oblast

Lviv, Lviv Oblast, 79021, Ukraine

Location

Kropyvnytskyi, Kropyvnytskyi

Kropyvnytskyi, 25491, Ukraine

Location

Kyiv, Kyïv

Kyiv, 04080, Ukraine

Location

Smila, Smila

Smila, 20708, Ukraine

Location

Vinnytsia, Vinnytsia

Vinnytsia, 21018, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: September 2, 2022
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BU (13); UA (6); US (62); PR (2); HU (2)