Actively Recruiting
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
Led by AbbVie · Updated on 2026-02-10
268
Participants Needed
7
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. 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.
CONDITIONS
Official Title
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18 and 40 kg/m2 and body weight over 50 kg (110 lbs)
- For Part A only: PANSS total score less than 80 at screening and baseline
- For Part B only: experiencing an acute worsening of psychotic symptoms starting less than 2 months before screening
- For Part B only: PANSS total score between 80 and 120 at screening and baseline
- For Part B only: score of 4 or higher (moderate or greater) on at least 2 PANSS Positive Scale items at screening and baseline
- For Part B only: Clinical Global Impression of Severity (CGIS) score of 4 or higher (at least moderately ill) at screening and baseline
You will not qualify if you...
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (nicotine and caffeine use disorders allowed)
- History of clozapine treatment
- History of resistance to schizophrenia medications, defined as not responding to 2 or more adequate treatment courses in the last 12 months
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Woodland International Research Group /ID# 275747
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Collaborative Neuroscience Research - Garden Grove /ID# 273005
Garden Grove, California, United States, 92845
Actively Recruiting
3
California Clinical Trials Medical Group - Parexel /ID# 275751
Glendale, California, United States, 91206
Actively Recruiting
4
Cbh Health - Gaithersburg /ID# 272932
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
5
Cenexel Hassman Research Institute (Hri) /ID# 276128
Marlton, New Jersey, United States, 08053
Actively Recruiting
6
Community Clinical Research - Austin - Cross Park Drive /ID# 272977
Austin, Texas, United States, 78754
Actively Recruiting
7
Pillar Clinical Research - Richardson /ID# 275715
Richardson, Texas, United States, 75080
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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