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TERMINATED

NCT05443724

PHASE2

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

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

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

Official title: A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

698

Start Date

2022-09-01

Completion Date

2025-06-25

Last Updated

2026-08-21

Healthy Volunteers

Conditions

Schizophrenia

Interventions

DRUG

Emraclidine 30 mg

Emraclidine 30 mg, oral (tablet), once per day for 52 weeks

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.

Locations (85)

Phoenix, Arizona

Phoenix, Arizona, United States

Bryant, Arkansas

Bryant, Arkansas, United States

Little Rock, Arkansas

Little Rock, Arkansas, United States

Anaheim, California

Anaheim, California, United States

Bellflower, California

Bellflower, California, United States

Culver City, California

Culver City, California, United States

Garden Grove, California

Garden Grove, California, United States

La Habra, California

La Habra, California, United States

Lemon Grove, California

Lemon Grove, California, United States

Montclair, California

Montclair, California, United States

Orange,California

Orange, California, United States

Pico Rivera, California

Pico Rivera, California, United States

Riverside, California

Riverside, California, United States

San Diego, California

San Diego, California, United States

San Diego, California

San Diego, 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

Walnut Creek, California

Walnut Creek, California, United States

New Haven, Connecticut

New Haven, Connecticut, United States

Bonita Springs,Florida

Bonita Springs, Florida, United States

Fort Myers, Florida

Fort Myers, Florida, United States

Hialeah, Florida

Hialeah, Florida, United States

Hialeah, Florida

Hialeah, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami Lakes, Florida

Miami Lakes, Florida, United States

Miami Lakes, Florida

Miami Lakes, Florida, United States

Miami Springs, Florida

Miami Springs, Florida, United States

Oakland Park, Florida

Oakland Park, Florida, United States

West Palm Beach, Florida

West Palm Beach, Florida, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Decatur, Georgia

Decatur, Georgia, United States

Savannah,Georgia

Savannah, Georgia, United States

Berwyn, Illinois

Berwyn, Illinois, United States

Chicago, Illinois