Status:
RECRUITING
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
Lead Sponsor:
AbbVie
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 advers...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT07145918
Start Date
August 4 2025
End Date
February 1 2028
Last Update
December 17 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Woodland International Research Group /ID# 275747
Little Rock, Arkansas, United States, 72211
2
Collaborative Neuroscience Research - Garden Grove /ID# 273005
Garden Grove, California, United States, 92845
3
California Clinical Trials Medical Group - Parexel /ID# 275751
Glendale, California, United States, 91206
4
Cbh Health - Gaithersburg /ID# 272932
Gaithersburg, Maryland, United States, 20877