Trial · NCT05227703
A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
NCT05227703, Phase 2, Completed, AbbVie; results first posted 2025-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia. Trials, record NCT05227703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05227703
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
- NCT number
- NCT05227703
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 391 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Schizophrenia
- Interventions
- Emraclidine 15 mg, Emraclidine 30 mg, Placebo
- First posted
- 2022-02-07
- Last updated
- 2025-10-28
- Results first posted
- 2025-10-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline through Week 6 | 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. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. |
| Secondary | Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score) | Baseline through Week 6 | 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 rated on the following 7-point scale: 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. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness. |
| Secondary | Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline; Weeks 1, 2, 3, 4, 5, and 6 | 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. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. |
| Secondary | Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score | Baseline; Weeks 1, 2, 3, 4, 5, and 6 | 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 rated on the following 7-point scale: 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. Baseline was defined as the last value obtained prior to initiation of Emraclidine. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness. |
| Secondary | Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in PANSS Total Score) | Baseline through Week 6 | 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 PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 6 or the early termination visit. If a subject discontinued and did not have an early termination visit, the subject's last assessment was considered. |
| Secondary | Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From first dose of study drug until 28 days following last dose of study drug (up to Week 10) | 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. |
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs) | Baseline; from first dose of study drug up to Week 6 | Assessment of clinically significant changes in electrocardiogram measures measured by 12-lead ECG recording after the participant has been supine and at rest for at least 3 minutes. |
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | Baseline; from first dose of study drug up to Week 6 | Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes. |
| Secondary | Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Baseline; from first dose of study drug up to Week 6 | 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. |
| Secondary | Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | Baseline; from first dose of study drug up to Week 6 | The number of participants with clinically significant changes in physical and neurological examination results was documented. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline through Week 6 | Modified Intent-to-Treat population (mITT): All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with a non-missing value. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score) | Baseline through Week 6 | mITT: All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with available data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline; Weeks 1, 2, 3, 4, 5, and 6 | mITT: All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with available data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score | Baseline; Weeks 1, 2, 3, 4, 5, and 6 | mITT: All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with available data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in PANSS Total Score) | Baseline through Week 6 | mITT: All randomized participants who receive at least 1 dose of Emraclidine and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with a non-missing value. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From first dose of study drug until 28 days following last dose of study drug (up to Week 10) | Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs) | Baseline; from first dose of study drug up to Week 6 | Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | Baseline; from first dose of study drug up to Week 6 | Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Baseline; from first dose of study drug up to Week 6 | Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | Baseline; from first dose of study drug up to Week 6 | Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score | Placebo | -16.1 | 95% Confidence Interval -19.4 to -12.8 | score on a scale | |
| Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score | Emraclidine 15mg QD | -18.5 | 95% Confidence Interval -22.0 to -15.0 | score on a scale | |
| Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score | Emraclidine 30mg QD | -14.2 | 95% Confidence Interval -17.5 to -10.8 | score on a scale | |
| Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score) | Placebo | -0.83 | 95% Confidence Interval -1.03 to -0.64 | score on a scale | |
| Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score) | Emraclidine 15 mg QD | -1.05 | 95% Confidence Interval -1.25 to -0.84 | score on a scale | |
| Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score) | Emraclidine 30 mg QD | -0.80 | 95% Confidence Interval -1.00 to -0.60 | score on a scale | |
| Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score | Placebo | Week 1 | -5.0 | 95% Confidence Interval -6.9 to -3.1 | score on a scale |
| Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score | Emraclidine 15 mg QD | Week 1 | -6.8 | 95% Confidence Interval -8.8 to -4.8 | score on a scale |
| Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score | Emraclidine 30 mg QD | Week 1 | -4.9 | 95% Confidence Interval -6.8 to -2.9 | score on a scale |
| Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score | Placebo | Week 2 | -8.5 | 95% Confidence Interval -10.9 to -6.1 | score on a scale |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 130 | |
| Overall Study | STARTED | Emraclidine 15 mg QD | 130 | |
| Overall Study | STARTED | Emraclidine 30 mg QD | 131 | |
| Overall Study | COMPLETED | Placebo | 102 | |
| Overall Study | COMPLETED | Emraclidine 15 mg QD | 93 | |
| Overall Study | COMPLETED | Emraclidine 30 mg QD | 93 | |
| Overall Study | NOT COMPLETED | Placebo | 28 | |
| Overall Study | NOT COMPLETED | Emraclidine 15 mg QD | 37 | |
| Overall Study | NOT COMPLETED | Emraclidine 30 mg QD | 38 |
Source ClinicalTrials.gov
Adverse events81
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | SINUS TACHYCARDIA | Cardiac disorders | Placebo | 0 | 130 | 0 |
| other | SINUS TACHYCARDIA | Cardiac disorders | Emraclidine 15mg QD | 4 | 130 | 5 |
| other | SINUS TACHYCARDIA | Cardiac disorders | Emraclidine 30mg QD | 0 | 131 | 0 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Placebo | 3 | 130 | 4 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Emraclidine 15mg QD | 4 | 130 | 4 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Emraclidine 30mg QD | 0 | 131 | 0 |
| other | CONSTIPATION | Gastrointestinal disorders | Placebo | 2 | 130 | 2 |
| other | CONSTIPATION | Gastrointestinal disorders | Emraclidine 15mg QD | 6 | 130 | 6 |
| other | CONSTIPATION | Gastrointestinal disorders | Emraclidine 30mg QD | 3 | 131 | 3 |
| other | DRY MOUTH | Gastrointestinal disorders | Placebo | 1 | 130 | 1 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 130 |
| Total, all-cause mortality | Emraclidine 15mg QD | 0 | 130 |
| Total, all-cause mortality | Emraclidine 30mg QD | 0 | 131 |
| Total, other adverse events | Placebo | 47 | 130 |
| Total, other adverse events | Emraclidine 15mg QD | 47 | 130 |
| Total, other adverse events | Emraclidine 30mg QD | 50 | 131 |
| Total, serious adverse events | Placebo | 1 | 130 |
| Total, serious adverse events | Emraclidine 15mg QD | 3 | 130 |
| Total, serious adverse events | Emraclidine 30mg QD | 1 | 131 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05227703
GET https://conductscience.org/api/trials/v1/NCT05227703/results?page=2