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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07145918

Registry updated: 2026-09-15
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Description

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.

Interventions

  • Emraclidine (Drug)
    Oral Tablets
  • Placebo (Drug)
    Oral Tablets

Eligibility criteria

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

Conditions

Schizophrenia

Locations

  • Woodland International Research Group /ID# 275747 — Little Rock, Arkansas, United States
  • California Clinical Trials Medical Group - Parexel /ID# 275751 — Glendale, California, United States
  • CenExel Collaborative Neuroscience Research /ID# 273005 — Los Alamitos, California, United States
  • Cbh Health - Gaithersburg /ID# 272932 — Gaithersburg, Maryland, United States
  • Cenexel Hassman Research Institute (Hri) /ID# 276128 — Marlton, New Jersey, United States
  • Community Clinical Research - Cross Park Drive /ID# 272977 — Austin, Texas, United States
  • Pillar Clinical Research - Richardson /ID# 275715 — Richardson, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record