Oral emraclidine for safety, symptom change, and how the body processes it in adults with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial randomizes about 268 adults with schizophrenia to receive oral emraclidine or placebo across two parts: Part A uses multiple ascending doses for 14–21 days and Part B treats participants for up to 42 days. The study collects safety and tolerability data, standardized symptom measures (including PANSS and CGI-S), and pharmacokinetic samples to characterize how the drug moves through the body. Participants are enrolled at roughly 32 sites in the United States and are followed for 30 days after the last dose. Outcomes will compare adverse events, changes in disease activity, and drug exposure between emraclidine and placebo groups.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.