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NCT Number: NCT07145918

A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult 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.

Participants in Part A will be assigned to one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Woodland International Research Group /ID# 275747, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emraclidine

Drug

Oral Tablets

Placebo

Drug

Oral Tablets

Primary outcomes

  1. 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.

  2. Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine

    Time frame: Up to approximately 24 days

    Cmax of Emraclidine

  3. Part A Only-Time to Cmax (Tmax) of Emraclidine

    Time frame: 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

    Time frame: 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

    Time frame: Up to approximately 24 days

    AUCtau of Emraclidine

  6. Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine

    Time frame: Up to approximately 21 days

    MRCmax of Emraclidine

  7. Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine

    Time frame: Up to approximately 21 days

    MRAUCtau of Emraclidine

  8. Part A Only- Minimum plasma concentration (Cmin) of Emraclidine

    Time frame: Up to approximately 21 days

    Cmin of Emraclidine

  9. Part A Only-Average plasma concentration (Cavg) of Emraclidine

    Time frame: Up to approximately 21 days

    Cavg of Emraclidine

  10. 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

  11. Part A Only-Terminal elimination rate constant (λz) of Emraclidine

    Time frame: Up to approximately 21 days

    λz of Emraclidine

  12. Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine

    Time frame: Up to approximately 21 days

    CL/F of Emraclidine

  13. Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine

    Time frame: Up to approximately 21 days

    Vz/F of Emraclidine

  14. Part A Only-Peak-to-trough ratio (PTR) of Emraclidine

    Time frame: Up to approximately 21 days

    PTR of Emraclidine

  15. Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine

    Time frame: Up to approximately 21 days

    RacCmax of Emraclidine

  16. Part A Only-Accumulation ratio for AUCta (RacAUCtau) of Emraclidine

    Time frame: Up to approximately 21 days

    RacAUCta of Emraclidine

  17. Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)

    Time frame: Up to approximately 24 days

    Cmax of Metabolite (CV-0000364)

  18. Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)

    Time frame: Up to approximately 24 days

    Tmax of Metabolite (CV-000036)

  19. 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)

  20. 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)

  21. Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036)

    Time frame: Up to approximately 21 days

    MRCmax of Metabolite (CV-000036)

  22. Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036)

    Time frame: Up to approximately 21 days

    MRAUCtau of Metabolite (CV-000036)

  23. 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.

Secondary outcomes

  1. Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    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.

  5. Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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