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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: CVL-231 30 mg

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Pazardzhik, Bulgaria, 4400
    • Pazardzhik, Pazardzhik
  • Pleven, Bulgaria, 5800
    • Pleven, Pleven
  • Sliven, Bulgaria, 8800
    • Sliven, Sliven
  • Stara Zagora, Bulgaria, 6003
    • Stara Zagora, Stara Zagora
  • Varna, Bulgaria, 9000
    • Varna, Varna
  • Veliko Tarnovo, Bulgaria, 5000
    • Veliko Tarnovo, Veliko Tarnovo
  • Vratsa, Bulgaria, 3000
    • Vratsa, Vratsa
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1431
      • Sofia, Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1202
      • Sofia, Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1407
      • Sofia, Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1510
      • Sofia, Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1606
      • Sofia, Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1680
      • Sofia, Sofia-Grad
• Hungary
  • Bács-Kiskun
    • Kalocsa, Bács-Kiskun, Hungary, 6300
      • Kalocsa, Bács-Kiskun
  • Gyor-Moson-Sopron
    • Gyor, Gyor-Moson-Sopron, Hungary, 9024
      • Győr, Győr-Moson-Sopron
• Puerto Rico
  • San Juan, Puerto Rico, 918
    • San Juan, Puerto Rico
  • San Juan, Puerto Rico, 926
    • San Juan, Puerto Rico
• Ukraine
  • Kropyvnytskyi, Ukraine, 25491
    • Kropyvnytskyi, Kropyvnytskyi
  • Kyiv, Ukraine, 04080
    • Kyiv, Kyïv
  • Smila, Ukraine, 20708
    • Smila, Smila
  • Vinnytsia, Ukraine, 21018
    • Vinnytsia, Vinnytsia
  • Ivano Frankivsk
    • Ivano-Frankivs'k, Ivano Frankivsk, Ukraine, 76011
      • Ivano Frankivsk, Ivano Frankivsk
  • L'vivs'ka Oblast
    • Lviv, L'vivs'ka Oblast, Ukraine, 79021
      • Lviv, L'vivs'ka Oblast
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012-2707
      • Phoenix, Arizona
  • Arkansas
    • Bryant, Arkansas, United States, 72022-9252
      • Bryant, Arkansas
    • Little Rock, Arkansas, United States, 72211-3702
      • Little Rock, Arkansas
  • California
    • Anaheim, California, United States, 92805-5854
      • Anaheim, California
    • Bellflower, California, United States, 90706-7079
      • Bellflower, California
    • Culver City, California, United States, 90230-6632
      • Culver City, California
    • Garden Grove, California, United States, 92845-2506
      • Garden Grove, California
    • La Habra, California, United States, 90631-3842
      • La Habra, California
    • Lemon Grove, California, United States, 91945-2956
      • Lemon Grove, California
    • Montclair, California, United States, 91763-2231
      • Montclair, California
    • Orange, California, United States, 92868-4447
      • Orange,California
    • Pico Rivera, California, United States, 90660-4920
      • Pico Rivera, California
    • Riverside, California, United States, 92506-3237
      • Riverside, California
    • San Diego, California, United States, 92103-2209
      • San Diego, California
    • San Diego, California, United States, 92123
      • San Diego, California
    • San Diego, California, United States, 92121
      • San Diego, California
    • Sherman Oaks, California, United States, 91403-1747
      • Sherman Oaks, California
    • Torrance, California, United States, 90502-4432
      • Torrance, California
    • Walnut Creek, California, United States, 94549
      • Walnut Creek, California
  • Connecticut
    • New Haven, Connecticut, United States, 06519-1109
      • New Haven, Connecticut
  • Florida
    • Bonita Springs, Florida, United States, 34134-4154
      • Bonita Springs,Florida
    • Fort Myers, Florida, United States, 33901-3711
      • Fort Myers, Florida
    • Hialeah, Florida, United States, 33012-4648
      • Hialeah, Florida
    • Hialeah, Florida, United States, 33016-1814
      • Hialeah, Florida
    • Miami, Florida, United States, 33155
      • Miami, Florida
    • Miami, Florida, United States, 33122-1335
      • Miami, Florida
    • Miami, Florida, United States, 33125-5114
      • Miami, Florida
    • Miami Lakes, Florida, United States, 33016-1553
      • Miami Lakes, Florida
    • Miami Lakes, Florida, United States, 33016
      • Miami Lakes, Florida
    • Miami Springs, Florida, United States, 33166-7225
      • Miami Springs, Florida
    • Oakland Park, Florida, United States, 33334-4135
      • Oakland Park, Florida
    • West Palm Beach, Florida, United States, 33407-2015
      • West Palm Beach, Florida
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta, Georgia
    • Atlanta, Georgia, United States, 30328-4018
      • Atlanta, Georgia
    • Atlanta, Georgia, United States, 30318-3102
      • Atlanta, Georgia
    • Decatur, Georgia, United States, 30030-3438
      • Decatur, Georgia
    • Savannah, Georgia, United States, 31405-5702
      • Savannah,Georgia
  • Illinois
    • Berwyn, Illinois, United States, 60402-2248
      • Berwyn, Illinois
    • Chicago, Illinois, United States, 60640-5017
      • Chicago, Illinois
    • Chicago, Illinois, United States, 60611-3478
      • Chicago, Illinois
    • Chicago, Illinois, United States, 60622-1702
      • Chicago, Illinois
    • Chicago, Illinois, United States, 60623
      • Chicago, Illinois
    • Chicago, Illinois, United States, 60641-4023
      • Chicago, Illinois
  • Louisiana
    • Marrero, Louisiana, United States, 70072-3083
      • Marrero, Louisiana
    • Shreveport, Louisiana, United States, 71101-4603
      • Shreveport, Louisiana
  • Maryland
    • Gaithersburg, Maryland, United States, 20877-1409
      • Gaithersburg, Maryland
  • Mississippi
    • Flowood, Mississippi, United States, 39232-8016
      • Flowood, Mississippi
  • Nevada
    • Las Vegas, Nevada, United States, 89102-1972
      • Las Vegas, Nevada
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Berlin, New Jersey
  • New York
    • Cedarhurst, New York, United States, 11516-1905
      • Cedarhurst, New York
    • New York, New York, United States, 10036-4811
      • New York, New York
    • Staten Island, New York, United States, 10314-1607
      • Staten Island, New York
  • North Carolina
    • Charlotte, North Carolina, United States, 28211-4849
      • Charlotte, North Carolina
  • Ohio
    • North Canton, Ohio, United States, 44718-2567
      • North Canton, Ohio
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102-1018
      • Oklahoma City, Oklahoma
  • Tennessee
    • Franklin, Tennessee, United States, 37067-5967
      • Franklin,Tennessee
  • Texas
    • Austin, Texas, United States, 78754-5122
      • Austin, Texas
    • DeSoto, Texas, United States, 75115-2066
      • Desoto, Texas
    • Houston, Texas, United States, 77043
      • Houston, Texas
    • Houston, Texas, United States, 77074
      • Houston, Texas
    • Plano, Texas, United States, 75093-0010
      • Plano, Texas
    • Richardson, Texas, United States, 75080-3764
      • Richardson, Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CVL-231 30 mg; Participants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks.	Drug: CVL-231 30 mg; Oral tablets; Other Names: Emraclidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Actual): June 25, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: CVL-231-2003; 2022-001151-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No