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
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
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