SchizophreniaPhase 2NCT07145918
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
A Phase 2 study testing Emraclidine in people with Schizophrenia, run by AbbVie at 7 sites in United States.
Trial summary
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Emraclidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Aug 2025to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight > 50 kg (110 lbs).
- (Part A only): Positive and Negative Syndrome Scale (PANSS) total score < 80 at Screening and at Baseline
- (Part B only): Participant experiencing an acute exacerbation of psychotic symptoms with onset less than 2 months prior to Screening
- (Part B only): Participant must have a PANSS total score from 80 to 120, inclusive, at Screening and at Baseline
- (Part B only): Participant MUST have a score of ≥ 4 (moderate or greater) for ≥ 2 of the following PANSS Positive Scale items at Screening and at Baseline
- (Part B only): Participant must have a Clinical Global Impression of Severity (CGIS) score ≥ 4 (at least moderately ill) at Screening and Baseline
Who cannot join
- Any primary DSM-5 disorder other than schizophrenia (current nicotine use disorder and caffeine use disorder are allowed) within 12 months before Screening.
- History of clozapine exposure.
- History of treatment resistance to schizophrenia medications, defined as failure to respond to 2 or more adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the last 12 months
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Community Clinical Research - Cross Park Drive /ID# 272977
Austin, Texas, 78754
Site Coordinator, 512-323-2622
- Recruiting
Cbh Health - Gaithersburg /ID# 272932
Gaithersburg, Maryland, 20877
Site Coordinator, 301-251-4702
- Recruiting
California Clinical Trials Medical Group - Parexel /ID# 275751
Glendale, California, 91206
Site Coordinator, 818-254-1600
- Recruiting
Woodland International Research Group /ID# 275747
Little Rock, Arkansas, 72211
Site Coordinator, 501-221-8681
- Recruiting
CenExel Collaborative Neuroscience Research /ID# 273005
Los Alamitos, California, 90720
- Recruiting
Cenexel Hassman Research Institute (Hri) /ID# 276128
Marlton, New Jersey, 08053
Site Coordinator, 888-437-4104
- Recruiting
Pillar Clinical Research - Richardson /ID# 275715
Richardson, Texas, 75080
Site Coordinator, 214-396-4844
About this study
Official title: An Adaptive Two-part Randomized, Double Blind, Placebo-controlled Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Emraclidine in Participants With Schizophrenia
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia
Emraclidine is an investigational drug being developed for the treatment of schizophrenia. Participants are placed in one of two parts, Part A or Part B, where each group will receive a different treatment. Participants will receive either oral emraclidine or placebo. Approximately 268 participants will be enrolled across roughly 32 sites in the United States.
Read more
Participants in Part A will be assigned to oral emraclidine or placebo administered for 14 days or up to 21 days depending on cohort. Cohorts without titration include a 14-day treatment period at target dose. Cohorts with titration are comprised of a titration period of up to 7 days and a 14-day treatment period at the cohort target dose. Participants in Part B will receive oral emraclidine or placebo. Participants will be followed for 30 days after the last dose of the study drug.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Conditions
- Schizophrenia
- Being tested
- Emraclidine, Placebo
- Keywords
- Schizophrenia, ABBV-1231
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmraclidineDrug
Oral Tablets
PlaceboDrug
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Emraclidine Part A | Experimental | Participants will be assigned to receive one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period. Receives: Drug: Emraclidine |
| Placebo-Part A | Experimental | Participants will be assigned to receive one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period. Receives: Drug: Placebo |
| Emraclidine-Part B | Experimental | Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period. Receives: Drug: Emraclidine |
| Placebo-Part B | Experimental | Participants will receive placebo for 42 days followed by a 30-day safety follow-up period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
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.
Measured: Up to approximately 74 days
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Cmax of Emraclidine
Measured: Up to approximately 24 days
Part A Only-Time to Cmax (Tmax) of Emraclidine
Tmax of Emraclidine
Measured: Up to approximately 24 days
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
AUCt of Emraclidine
Measured: Up to approximately 24 days
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
AUCtau of Emraclidine
Measured: Up to approximately 24 days
Part A Only- Minimum plasma concentration (Cmin) of Emraclidine
Cmin of Emraclidine
Measured: Up to approximately 21 days
Part A Only-Average plasma concentration (Cavg) of Emraclidine
Cavg of Emraclidine
Measured: Up to approximately 21 days
Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Terminal phase elimination half-life of Emraclidine
Measured: Up to approximately 21 days
Part A Only-Terminal elimination rate constant (λz) of Emraclidine
λz of Emraclidine
Measured: Up to approximately 21 days
Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
CL/F of Emraclidine
Measured: Up to approximately 21 days
Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Vz/F of Emraclidine
Measured: Up to approximately 21 days
Part A Only-Peak-to-trough ratio (PTR) of Emraclidine
PTR of Emraclidine
Measured: Up to approximately 21 days
Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine
RacCmax of Emraclidine
Measured: Up to approximately 21 days
Part A Only-Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
RacAUCtau of Emraclidine
Measured: Up to approximately 21 days
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Cmax of Metabolite (CV-0000364)
Measured: Up to approximately 24 days
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036)
AUCtau of Metabolite (CV-000036)
Measured: Up to approximately 24 days
Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)
Tmax of Metabolite (CV-0000364)
Measured: Up to approximately 24 days
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
AUCt of Metabolite (CV-000036)
Measured: Up to approximately 24 days
Part A Only-Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364) calculated from Cmax
MRCmax of Metabolite (CV-000036)
Measured: Up to approximately 21 days
Part A Only- Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-0000364)
MRAUCtau of Metabolite (CV-0000364)
Measured: Up to approximately 21 days
Part A Only- Terminal Phase Elimination Half-Life (t1/2) of of Metabolite (CV-0000364)
Terminal phase elimination half-life of Metabolite (CV-0000364)
Measured: Up to approximately 21 days
Part A Only-Terminal elimination rate constant (λz) of Metabolite (CV-0000364)
λz of Metabolite (CV-0000364)
Measured: Up to approximately 21 days
Part A Only-Peak-to-trough ratio (PTR) of Metabolite (CV-0000364)
PTR of Metabolite (CV-0000364)
Measured: Up to approximately 21 days
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Measured: Up to approximately week 6
Part B Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Cmax of Emraclidine
Measured: Up to approximately 24 days
Part B Only-Time to Cmax (Tmax) of Emraclidine
Tmax of Emraclidine
Measured: Up to approximately 24 days
Part B Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
AUCt of Emraclidine
Measured: Up to approximately 24 days
Part B Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
AUCtau of Emraclidine
Measured: Up to approximately 24 days
Secondary outcomes (5)
Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score
CGIS is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity.
Measured: Up to approximately Week 6
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Measured: Up to approximately 74 days
Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score
CGIS is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity.
Measured: Up to approximately 53 days
Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Measured: Up to approximately week 6
Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60)
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Measured: Up to approximately week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start4 Aug 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145918
- Sponsor's protocol ID
- M25-522
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Two-part Randomized, Double Blind, Placebo-controlled Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Emraclidine in Participants With Schizophrenia
- ClinicalTrials.gov ID
- NCT07145918
- Acronym / sponsor ID
- M25-522
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, ABBV-1231
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia
Emraclidine is an investigational drug being developed for the treatment of schizophrenia. Participants are placed in one of two parts, Part A or Part B, where each group will receive a different treatment. Participants will receive either oral emraclidine or placebo. Approximately 268 participants will be enrolled across roughly 32 sites in the United States.
Participants in Part A will be assigned to oral emraclidine or placebo administered for 14 days or up to 21 days depending on cohort. Cohorts without titration include a 14-day treatment period at target dose. Cohorts with titration are comprised of a titration period of up to 7 days and a 14-day treatment period at the cohort target dose. Participants in Part B will receive oral emraclidine or placebo. Participants will be followed for 30 days after the last dose of the study drug.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Emraclidine Part A | Experimental | Drug: EmraclidineParticipants will be assigned to receive one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period. |
| Placebo-Part A | Experimental | Drug: PlaceboParticipants will be assigned to receive one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period. |
| Emraclidine-Part B | Experimental | Drug: EmraclidineParticipants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period. |
| Placebo-Part B | Experimental | Drug: PlaceboParticipants will receive placebo for 42 days followed by a 30-day safety follow-up period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight > 50 kg (110 lbs).
- (Part A only): Positive and Negative Syndrome Scale (PANSS) total score < 80 at Screening and at Baseline
- (Part B only): Participant experiencing an acute exacerbation of psychotic symptoms with onset less than 2 months prior to Screening
- (Part B only): Participant must have a PANSS total score from 80 to 120, inclusive, at Screening and at Baseline
- (Part B only): Participant MUST have a score of ≥ 4 (moderate or greater) for ≥ 2 of the following PANSS Positive Scale items at Screening and at Baseline
Key exclusion criteria (3 listed)
- Any primary DSM-5 disorder other than schizophrenia (current nicotine use disorder and caffeine use disorder are allowed) within 12 months before Screening.
- History of clozapine exposure.
- History of treatment resistance to schizophrenia medications, defined as failure to respond to 2 or more adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmraclidineOral Tablets | Drug | Emraclidine Part A, Emraclidine-Part B |
| PlaceboOral Tablets | Drug | Placebo-Part A, Placebo-Part B |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 74 days
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.
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time frame: Up to approximately 24 days
Cmax of Emraclidine
Part A Only-Time to Cmax (Tmax) of Emraclidine
Time frame: Up to approximately 24 days
Tmax of Emraclidine
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
Time frame: Up to approximately 24 days
AUCt of Emraclidine
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
Time frame: Up to approximately 24 days
AUCtau of Emraclidine
Part A Only- Minimum plasma concentration (Cmin) of Emraclidine
Time frame: Up to approximately 21 days
Cmin of Emraclidine
Part A Only-Average plasma concentration (Cavg) of Emraclidine
Time frame: Up to approximately 21 days
Cavg of Emraclidine
Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Time frame: Up to approximately 21 days
Terminal phase elimination half-life of Emraclidine
Part A Only-Terminal elimination rate constant (λz) of Emraclidine
Time frame: Up to approximately 21 days
λz of Emraclidine
Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
Time frame: Up to approximately 21 days
CL/F of Emraclidine
Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Time frame: Up to approximately 21 days
Vz/F of Emraclidine
Part A Only-Peak-to-trough ratio (PTR) of Emraclidine
Time frame: Up to approximately 21 days
PTR of Emraclidine
Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine
Time frame: Up to approximately 21 days
RacCmax of Emraclidine
Part A Only-Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
Time frame: Up to approximately 21 days
RacAUCtau of Emraclidine
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 24 days
Cmax of Metabolite (CV-0000364)
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036)
Time frame: Up to approximately 24 days
AUCtau of Metabolite (CV-000036)
Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 24 days
Tmax of Metabolite (CV-0000364)
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
Time frame: Up to approximately 24 days
AUCt of Metabolite (CV-000036)
Part A Only-Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364) calculated from Cmax
Time frame: Up to approximately 21 days
MRCmax of Metabolite (CV-000036)
Part A Only- Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-0000364)
Time frame: Up to approximately 21 days
MRAUCtau of Metabolite (CV-0000364)
Part A Only- Terminal Phase Elimination Half-Life (t1/2) of of Metabolite (CV-0000364)
Time frame: Up to approximately 21 days
Terminal phase elimination half-life of Metabolite (CV-0000364)
Part A Only-Terminal elimination rate constant (λz) of Metabolite (CV-0000364)
Time frame: Up to approximately 21 days
λz of Metabolite (CV-0000364)
Part A Only-Peak-to-trough ratio (PTR) of Metabolite (CV-0000364)
Time frame: Up to approximately 21 days
PTR of Metabolite (CV-0000364)
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Up to approximately week 6
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Part B Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time frame: Up to approximately 24 days
Cmax of Emraclidine
Part B Only-Time to Cmax (Tmax) of Emraclidine
Time frame: Up to approximately 24 days
Tmax of Emraclidine
Part B Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
Time frame: Up to approximately 24 days
AUCt of Emraclidine
Part B Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
Time frame: Up to approximately 24 days
AUCtau of Emraclidine
5 secondary outcomes
Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score
Time frame: Up to approximately Week 6
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Up to approximately 74 days
Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score
Time frame: Up to approximately 53 days
Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score
Time frame: Up to approximately week 6
Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60)
Time frame: Up to approximately week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emraclidine in people with Schizophrenia, run by AbbVie at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 74 days). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.