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

AbbVie · NCT07145918

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
268
US sites recruiting
7
Study start
August 4, 2025
Record last updated
September 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Emraclidine; Placebo

Conditions: Schizophrenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Woodland International Research Group /ID# 275747

    Little Rock, AR 72211

    Site contact: Site Coordinator · 501-221-8681

  • California Clinical Trials Medical Group - Parexel /ID# 275751

    Glendale, CA 91206

    Site contact: Site Coordinator · 818-254-1600

  • CenExel Collaborative Neuroscience Research /ID# 273005

    Los Alamitos, CA 90720

  • Cbh Health - Gaithersburg /ID# 272932

    Gaithersburg, MD 20877

    Site contact: Site Coordinator · 301-251-4702

  • Cenexel Hassman Research Institute (Hri) /ID# 276128

    Marlton, NJ 08053

    Site contact: Site Coordinator · 888-437-4104

  • Community Clinical Research - Cross Park Drive /ID# 272977

    Austin, TX 78754

    Site contact: Site Coordinator · 512-323-2622

  • Pillar Clinical Research - Richardson /ID# 275715

    Richardson, TX 75080

    Site contact: Site Coordinator · 214-396-4844

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
A Study to Assess Adverse Events, Change in Disease Activity, and… (NCT07145918) | Bored Studies