A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in... | NCT05227690

ID	Type	Description	Link
2022-000580-52	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.	Drug: Placebo
Emraclidine 10 mg, once daily (QD)	Experimental	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.	Drug: Emraclidine 10 mg
Emraclidine 30 mg, once daily (QD)	Experimental	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.	Drug: Emraclidine 30 mg

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Matching placebo, oral (tablet), once per day for 6 weeks	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score	The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.	Baseline through Week 6

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)	The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer was based on the following scale: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative changes from Baseline indicate less mental illness.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders.
CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline.
PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline.
Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF.
Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs).
Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.

Exclusion Criteria:

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 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
Any of the following regarding history of schizophrenia:
- Time from initial onset of schizophrenia <2 years based on prior records or participant self-report
- Presenting with an initial diagnosis of schizophrenia
- Presenting for the first time with an acute psychotic episode requiring treatment
Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline.
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 course of 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 Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment.
Any condition that could possibly affect drug absorption.
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 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 IMP are also excluded.

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Little Rock, Arkansas		Little Rock	Arkansas	72211-3702	United States
Anaheim, California

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
FG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 15, 2023	Aug 13, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score

Modified Intent-to-Treat population (mITT): All randomized participants who received at least 1 dose of investigational medicinal product (IMP) and have both a Baseline and at least 1 post-Baseline PANSS assessment; participants with available data

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline through Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Units	Counts
Participants	OG00087 OG00190 OG00293

Title

Denominators

Categories

Title	Measurements
	OG000-13.5(-17.0 to -10.0) OG001-14.7(-18.1 to -11.2) OG002-16.5(-20.0 to -13.1)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Emraclidine 30 mg versus Placebo	Mixed Model for Repeated Measures (MMRM)		=0.1765		LS Mean Difference	-3.0	Standard Error of the Mean	2.24	2-Sided	95	-7.5	1.4			Emraclidine 30 mg - Placebo		Superiority	Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.

Secondary

Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)

The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer was based on the following scale: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative changes from Baseline indicate less mental illness.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline through Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)

Secondary

Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline; Weeks 1, 2, 3, 4, 5, and 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Secondary

Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline; Weeks 1, 2, 3, 4, 5, and 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)

Secondary

Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in Positive and Negative Syndrome Scale [PANSS] Total Score)

The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. A PANSS responder is defined as a participant with at least a 30% decrease in PANSS total score compared to Baseline at Week 6 visit or the early termination visit. If a participant discontinued and did not have an early termination visit, the participant's last assessment was considered.

Posted

Number

percentage of participants

Baseline through Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.

Secondary

Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

From first dose of study drug until 28 days following last dose of study drug (up to Week 10)

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)

Secondary

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)

12-lead electrocardiogram (ECG) recordings were obtained after the participant had been supine and at rest for at least 3 minutes.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Units	Counts

Secondary

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Units	Counts

Secondary

Number of Participants With Clinically Significant Changes in Vital Sign Measurements

Vital signs were obtained after the participant had been supine and at rest for 3 minutes and included temperature, systolic and diastolic blood pressure, respiratory rate, and heart rate. Participants' body weights were also measured and recorded.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Secondary

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

The number of participants with clinically significant changes in physical and neurological examination results was documented.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Units	Counts

Secondary

Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)

The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Secondary

Change From Baseline in Simpson Angus Scale (SAS) Total Score

The SAS consists of a list of 10 symptoms of Parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items. Negative changes from Baseline indicate an improvement in symptoms.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline; Weeks 3 and 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Secondary

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score

The Abnormal Involuntary Movement Scale assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the participant is at rest, and the investigator also makes global judgments on the participant's dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status.

The AIMS Movement Rating Score is defined as the sum of individual scores from items 1-7, ranging from 0 to 28. A lower score indicates less severe or absent abnormal movements. A negative change in the mean from Baseline indicates improvement in the severity of abnormal involuntary movements.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline; Weeks 3 and 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)

Secondary

Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score

The BARS consists of 4 items related to akathisia: The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia. Negative changes from Baseline indicate an improvement in symptoms.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline; Weeks 3 and 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
OG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
OG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
SINUS TACHYCARDIA	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected128 at risk EG0012 events2 affected128 at risk EG0028 events6 affected129 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected128 at risk EG0010 events0 affected128 at risk EG0020 events0 affected129 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected128 at risk EG0013 events3 affected128 at risk EG0023 events3 affected129 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected128 at risk EG0015 events5 affected128 at risk EG00212 events12 affected129 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0005 events4 affected128 at risk EG0015 events5 affected128 at risk EG00210 events10 affected129 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected128 at risk EG0013 events3 affected128 at risk EG0025 events4 affected129 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected128 at risk EG0014 events3 affected128 at risk EG0027 events6 affected129 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected128 at risk EG0011 events1 affected128 at risk EG0023 events3 affected129 at risk
FATIGUE	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected128 at risk EG0025 events5 affected129 at risk
TOOTH ABSCESS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected128 at risk EG0024 events3 affected129 at risk
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected128 at risk EG0014 events4 affected128 at risk EG0023 events3 affected129 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected128 at risk EG0024 events4 affected129 at risk
WEIGHT INCREASED	Investigations	MedDRA 27.0	Systematic Assessment	EG00011 events11 affected128 at risk EG00122 events22 affected128 at risk EG0028 events8 affected129 at risk
INCREASED APPETITE	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected128 at risk EG0013 events3 affected128 at risk EG0020 events0 affected129 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected128 at risk EG0013 events3 affected128 at risk EG0026 events5 affected129 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected128 at risk EG0012 events1 affected128 at risk EG0028 events8 affected129 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected128 at risk EG0015 events4 affected128 at risk EG0021 events1 affected129 at risk
DIZZINESS	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected128 at risk EG0011 events1 affected128 at risk EG0024 events3 affected129 at risk
HEADACHE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00014 events12 affected128 at risk EG00120 events18 affected128 at risk EG00218 events17 affected129 at risk
SOMNOLENCE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0006 events6 affected128 at risk EG00111 events9 affected128 at risk EG0029 events9 affected129 at risk
AGITATION	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected128 at risk EG0011 events1 affected128 at risk EG0028 events5 affected129 at risk
ANXIETY	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected128 at risk EG0011 events1 affected128 at risk EG0023 events3 affected129 at risk
INSOMNIA	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected128 at risk EG0017 events6 affected128 at risk EG0023 events3 affected129 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected128 at risk EG0013 events3 affected128 at risk EG0022 events2 affected129 at risk
SCHIZOPHRENIA	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected128 at risk EG0011 events1 affected128 at risk EG0024 events4 affected129 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected128 at risk EG0011 events1 affected128 at risk EG0024 events4 affected129 at risk

ID	Term
D012559	Schizophrenia
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Title	Description
BG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
BG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
BG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.	128	2	128	56	128
EG001	Emraclidine 10 mg, Once Daily (QD)	Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.	128	4	128	66	128
EG002	Emraclidine 30 mg, Once Daily (QD)	Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.	129	1	129	74	129

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DYSTONIA	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected128 at risk EG0020 events0 affected129 at risk
AGGRESSION	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected128 at risk EG0021 events1 affected129 at risk
AGITATION	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected128 at risk EG0020 events0 affected129 at risk
SCHIZOPHRENIA	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected128 at risk EG0012 events2 affected128 at risk EG0020 events0 affected129 at risk