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A Study to Evaluate Safety an...

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

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-02

Study Completion Date

2025-06-25

Brief Summary

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

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CVL-231 30 mg

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

Group Type EXPERIMENTAL

CVL-231 30 mg

Intervention Type DRUG

Oral tablets

Interventions

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CVL-231 30 mg

Oral tablets

Intervention Type DRUG

Other Intervention Names

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Emraclidine

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.
3. Participants who have been stable on antipsychotic medication for at least one 3-month in the year prior to screening.
4. Outpatient status at the time of signing the informed consent form informed consent form (ICF).
5. Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
6. Ability, in the investigator's opinion, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.

Exclusion Criteria

1. 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.
2. 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.
3. 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.
4. 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
5. 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.
6. Risk for suicidal behavior as assessed by the C-SSRS and investigator's clinical assessment.
7. Any condition that could possibly affect drug absorption, including, but not limited to bowel resections, bariatric weight loss surgery, gastric banding, and gastrectomy
8. Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial.
9. Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening.
10. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Phoenix, Arizona

Phoenix, Arizona, United States

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Bryant, Arkansas

Bryant, Arkansas, United States

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Little Rock, Arkansas

Little Rock, Arkansas, United States

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Anaheim, California

Anaheim, California, United States

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Bellflower, California

Bellflower, California, United States

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Culver City, California

Culver City, California, United States

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Garden Grove, California

Garden Grove, California, United States

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La Habra, California

La Habra, California, United States

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Lemon Grove, California

Lemon Grove, California, United States

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Montclair, California

Montclair, California, United States

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Orange,California

Orange, California, United States

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Pico Rivera, California

Pico Rivera, California, United States

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Riverside, California

Riverside, California, United States

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San Diego, California

San Diego, California, United States

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San Diego, California

San Diego, California, United States

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San Diego, California

San Diego, California, United States

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Sherman Oaks, California

Sherman Oaks, California, United States

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Torrance, California

Torrance, California, United States

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Walnut Creek, California

Walnut Creek, California, United States

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New Haven, Connecticut

New Haven, Connecticut, United States

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Bonita Springs,Florida

Bonita Springs, Florida, United States

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Fort Myers, Florida

Fort Myers, Florida, United States

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Hialeah, Florida

Hialeah, Florida, United States

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Hialeah, Florida

Hialeah, Florida, United States

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Miami, Florida

Miami, Florida, United States

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Miami, Florida

Miami, Florida, United States

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Miami, Florida

Miami, Florida, United States

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Miami Lakes, Florida

Miami Lakes, Florida, United States

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Miami Lakes, Florida

Miami Lakes, Florida, United States

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Miami Springs, Florida

Miami Springs, Florida, United States

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Oakland Park, Florida

Oakland Park, Florida, United States

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West Palm Beach, Florida

West Palm Beach, Florida, United States

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Atlanta, Georgia

Atlanta, Georgia, United States

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Atlanta, Georgia

Atlanta, Georgia, United States

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Atlanta, Georgia

Atlanta, Georgia, United States

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Decatur, Georgia

Decatur, Georgia, United States

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Savannah,Georgia

Savannah, Georgia, United States

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