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

NCT07145918
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
268
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Lead sponsor
AbbVie
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Start date
2025-08-04
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Number of sites
7
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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.
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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
clinicaltrials.gov
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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-02-01
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First posted
2025-08-28
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Registry last updated
2026-09-15
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Primary completion date
2028-02-01
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Start date
2025-08-04
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Participants
268
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Participant count basis
Estimated
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Planned participants
268
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Protocol amendments
2
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Number of sites
7
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07145918
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ClinicalTrials.gov ID
NCT07145918
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)