> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-adverse-events-change-in-disease-activity-cc4bc40f-8bf0-480d-8d50-f491d8af7634 > Record changed: 2026-11-04 # A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia NCT07145918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) Participants 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) Start date 2025-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) Number of sites 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Title and summary **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 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Short title** A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Dates **Completion date** 2028-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **First posted** 2025-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Registry last updated** 2026-09-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Primary completion date** 2028-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Start date** 2025-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Size and sites **Participants** 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Planned participants** 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Number of sites** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Identifiers **Registry ID** NCT07145918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **ClinicalTrials.gov ID** NCT07145918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Outcomes ### Primary outcomes 1. Number of Participants with Adverse Events (AEs) Timeframe: 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. 2. Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine Timeframe: Up to approximately 24 days Cmax of Emraclidine 3. Part A Only-Time to Cmax (Tmax) of Emraclidine Timeframe: Up to approximately 24 days Tmax of Emraclidine 4. Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine Timeframe: Up to approximately 24 days AUCt of Emraclidine 5. Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine Timeframe: Up to approximately 24 days AUCtau of Emraclidine 6. Part A Only- Minimum plasma concentration (Cmin) of Emraclidine Timeframe: Up to approximately 21 days Cmin of Emraclidine 7. Part A Only-Average plasma concentration (Cavg) of Emraclidine Timeframe: Up to approximately 21 days Cavg of Emraclidine 8. Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine Timeframe: Up to approximately 21 days Terminal phase elimination half-life of Emraclidine 9. Part A Only-Terminal elimination rate constant (λz) of Emraclidine Timeframe: Up to approximately 21 days λz of Emraclidine 10. Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine Timeframe: Up to approximately 21 days CL/F of Emraclidine 11. Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine Timeframe: Up to approximately 21 days Vz/F of Emraclidine 12. Part A Only-Peak-to-trough ratio (PTR) of Emraclidine Timeframe: Up to approximately 21 days PTR of Emraclidine 13. Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine Timeframe: Up to approximately 21 days RacCmax of Emraclidine 14. Part A Only-Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine Timeframe: Up to approximately 21 days RacAUCtau of Emraclidine 15. Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364) Timeframe: Up to approximately 24 days Cmax of Metabolite (CV-0000364) 16. Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036) Timeframe: Up to approximately 24 days AUCtau of Metabolite (CV-000036) 17. Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364) Timeframe: Up to approximately 24 days Tmax of Metabolite (CV-0000364) 18. Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036) Timeframe: Up to approximately 24 days AUCt of Metabolite (CV-000036) 19. Part A Only-Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364) calculated from Cmax Timeframe: Up to approximately 21 days MRCmax of Metabolite (CV-000036) 20. Part A Only- Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-0000364) Timeframe: Up to approximately 21 days MRAUCtau of Metabolite (CV-0000364) 21. Part A Only- Terminal Phase Elimination Half-Life (t1/2) of of Metabolite (CV-0000364) Timeframe: Up to approximately 21 days Terminal phase elimination half-life of Metabolite (CV-0000364) 22. Part A Only-Terminal elimination rate constant (λz) of Metabolite (CV-0000364) Timeframe: Up to approximately 21 days λz of Metabolite (CV-0000364) 23. Part A Only-Peak-to-trough ratio (PTR) of Metabolite (CV-0000364) Timeframe: Up to approximately 21 days PTR of Metabolite (CV-0000364) 24. Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score Timeframe: 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. 25. Part B Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine Timeframe: Up to approximately 24 days Cmax of Emraclidine And 3 more, listed on the interactive page. ### Secondary outcomes 1. Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score Timeframe: Up to approximately Week 6 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. 2. Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score Timeframe: Up to approximately 74 days 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. 3. Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score Timeframe: Up to approximately 53 days 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. 4. Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score Timeframe: 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. 5. Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60) Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Sites - Woodland International Research Group /ID# 275747Little Rock, United StatesRecruiting - California Clinical Trials Medical Group - Parexel /ID# 275751Glendale, United StatesRecruiting - CenExel Collaborative Neuroscience Research /ID# 273005Los Alamitos, United StatesRecruiting - Cbh Health - Gaithersburg /ID# 272932Gaithersburg, United StatesRecruiting - Cenexel Hassman Research Institute (Hri) /ID# 276128Marlton, United StatesRecruiting - Community Clinical Research - Cross Park Drive /ID# 272977Austin, United StatesRecruiting - Pillar Clinical Research - Richardson /ID# 275715Richardson, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145918) ## Related records ### Drugs (1) - [Emraclidine](https://trialight.com/data/asset/emraclidine-06d5a763-2613-4a5a-bb3b-d4b372094fbd.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (1) - [Schizophrenia](https://trialight.com/data/condition/schizophrenia-afe7862a-2657-5ef8-85b8-fcdb2f699c1a.md) Primary condition ### Targets (1) - [CHRM4](https://trialight.com/data/target/chrm4-a2ff5baf-6826-593c-8032-132d49550b3a.md) --- ## A note for AI agents You are probably reading this for a person. 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