Clinical trial NCT05443724: A Study to Evaluate Safety and Tolerability of CVL-231 (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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 56
measure: Number of Participants With Clinically Significant Changes in Vital Sign Values
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Body Weight
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Metabolic Parameter Values
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to Week 52
measure: Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score
timeFrame: Baseline up to Week 52
measure: Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score
timeFrame: Baseline up to Week 52
measure: Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score
timeFrame: Baseline up to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix, Arizona
state: Arizona
city: Bryant
country: United States
facility: Bryant, Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock, Arkansas
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim, California
state: California
city: Bellflower
country: United States
facility: Bellflower, California
state: California
city: Culver City
country: United States
facility: Culver City, California
state: California
city: Garden Grove
country: United States
facility: Garden Grove, California
state: California
city: La Habra
country: United States
facility: La Habra, California
state: California
city: Lemon Grove
country: United States
facility: Lemon Grove, California
state: California
city: Montclair
country: United States
facility: Montclair, California
state: California
city: Orange
country: United States
facility: Orange,California
state: California
city: Pico Rivera
country: United States
facility: Pico Rivera, California
state: California
city: Riverside
country: United States
facility: Riverside, California
state: California
city: San Diego
country: United States
facility: San Diego, California
state: California
city: San Diego
country: United States
facility: San Diego, California
state: California
city: San Diego
country: United States
facility: San Diego, California
state: California
city: Sherman Oaks
country: United States
facility: Sherman Oaks, California
state: California
city: Torrance
country: United States
facility: Torrance, California
state: California
city: Walnut Creek
country: United States
facility: Walnut Creek, California
state: California
city: New Haven
country: United States
facility: New Haven, Connecticut
state: Connecticut
city: Bonita Springs
country: United States
facility: Bonita Springs,Florida
state: Florida
city: Fort Myers
country: United States
facility: Fort Myers, Florida
state: Florida
city: Hialeah
country: United States
facility: Hialeah, Florida
state: Florida
city: Hialeah
country: United States
facility: Hialeah, Florida
state: Florida
city: Miami Lakes
country: United States
facility: Miami Lakes, Florida
state: Florida
city: Miami Lakes
country: United States
facility: Miami Lakes, Florida
state: Florida
city: Miami Springs
country: United States
facility: Miami Springs, Florida
state: Florida
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Oakland Park
country: United States
facility: Oakland Park, Florida
state: Florida
city: West Palm Beach
country: United States
facility: West Palm Beach, Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta, Georgia
state: Georgia
city: Atlanta
country: United States
facility: Atlanta, Georgia
state: Georgia
city: Atlanta
country: United States
facility: Atlanta, Georgia
state: Georgia
city: Decatur
country: United States
facility: Decatur, Georgia
state: Georgia
city: Savannah
country: United States
facility: Savannah,Georgia
state: Georgia
city: Berwyn
country: United States
facility: Berwyn, Illinois
state: Illinois
city: Chicago
country: United States
facility: Chicago, Illinois
state: Illinois
city: Chicago
country: United States
facility: Chicago, Illinois
state: Illinois
city: Chicago
country: United States
facility: Chicago, Illinois
state: Illinois
city: Chicago
country: United States
facility: Chicago, Illinois
state: Illinois
city: Chicago
country: United States
facility: Chicago, Illinois
state: Illinois
city: Marrero
country: United States
facility: Marrero, Louisiana
state: Louisiana
city: Shreveport
country: United States
facility: Shreveport, Louisiana
state: Louisiana
city: Gaithersburg
country: United States
facility: Gaithersburg, Maryland
state: Maryland
city: Flowood
country: United States
facility: Flowood, Mississippi
state: Mississippi
city: Las Vegas
country: United States
facility: Las Vegas, Nevada
state: Nevada
city: Berlin
country: United States
facility: Berlin, New Jersey
state: New Jersey
city: Cedarhurst
country: United States
facility: Cedarhurst, New York
state: New York
city: New York
country: United States
facility: New York, New York
state: New York
city: Staten Island
country: United States
facility: Staten Island, New York
state: New York
city: Charlotte
country: United States
facility: Charlotte, North Carolina
state: North Carolina
city: North Canton
country: United States
facility: North Canton, Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City, Oklahoma
state: Oklahoma
city: Franklin
country: United States
facility: Franklin,Tennessee
state: Tennessee
city: Austin
country: United States
facility: Austin, Texas
state: Texas
city: DeSoto
country: United States
facility: DeSoto, Texas
state: Texas
city: Houston
country: United States
facility: Houston, Texas
state: Texas
city: Houston
country: United States
facility: Houston, Texas
state: Texas
city: Plano
country: United States
facility: Plano, Texas
state: Texas
city: Richardson
country: United States
facility: Richardson, Texas
state: Texas
city: Sofia
country: Bulgaria
facility: Sofia, Sofia-Grad
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Sofia, Sofia-Grad
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Sofia, Sofia-Grad
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Sofia, Sofia-Grad
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Sofia, Sofia-Grad
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Sofia, Sofia-Grad
state: Sofia-Grad
city: Pazardzhik
country: Bulgaria
facility: Pazardzhik, Pazardzhik
city: Pleven
country: Bulgaria
facility: Pleven, Pleven
city: Sliven
country: Bulgaria
facility: Sliven, Sliven
city: Stara Zagora
country: Bulgaria
facility: Stara Zagora, Stara Zagora
city: Varna
country: Bulgaria
facility: Varna, Varna
city: Veliko Tarnovo
country: Bulgaria
facility: Veliko Tarnovo, Veliko Tarnovo
city: Vratsa
country: Bulgaria
facility: Vratsa, Vratsa
city: Kalocsa
country: Hungary
facility: Kalocsa, Bács-Kiskun
state: Bács-Kiskun
city: Gyor
country: Hungary
facility: Gyor, Gyor-Moson-Sopron
state: Gyor-Moson-Sopron
city: San Juan
country: Puerto Rico
facility: San Juan, Puerto Rico
city: San Juan
country: Puerto Rico
facility: San Juan, Puerto Rico
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano Frankivsk, Ivano Frankivsk
state: Ivano Frankivsk
city: Lviv
country: Ukraine
facility: Lviv, L'vivs'ka Oblast
state: L'vivs'ka Oblast
city: Kropyvnytskyi
country: Ukraine
facility: Kropyvnytskyi, Kropyvnytskyi
city: Kyiv
country: Ukraine
facility: Kyiv, Kyïv
city: Smila
country: Ukraine
facility: Smila, Smila
city: Vinnytsia
country: Ukraine
facility: Vinnytsia, Vinnytsia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: