Actively Recruiting
An Adaptive Two-part Randomized, Double Blind, Placebo-controlled Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Emraclidine in Participants With Schizophrenia
Led by AbbVie · Updated on 2026-02-10
268
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Schizophrenia is a serious psychiatric illness marked by significant disturbances in thinking, language, perception, and self-awareness. Researchers are evaluating the safety, effects on disease activity, and how the investigational drug emraclidine is processed in the body in adults with schizophrenia. This is a Phase 2 study designed to explore these aspects with careful monitoring. Participants are divided into two parts. In Part A, participants receive different increasing doses of oral emraclidine or placebo for 14 to 21 days. In Part B, participants receive oral emraclidine or placebo for up to 42 days. Following treatment, all participants enter a 30-day safety follow-up to monitor any lasting effects. During the study, participants will attend regular clinic visits for medical exams, blood tests, and questionnaires to check for side effects and disease changes. Researchers will measure adverse events, drug levels in the blood, and changes in schizophrenia symptoms using specific scales. The total participation time may be up to about 74 days including treatment and follow-up.
CONDITIONS
Brief 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...
- Adults aged 18 to 65 years
- Body mass index (BMI) between 18 and 40 kg/m2 and body weight over 50 kg (110 lbs)
- For Part A: PANSS total score less than 80 at screening and baseline
- For Part B: Experiencing an acute worsening of psychotic symptoms within 2 months before screening
- For Part B: PANSS total score between 80 and 120 at screening and baseline
- For Part B: Score of 4 or higher on at least 2 PANSS Positive Scale items at screening and baseline
- For Part B: Clinical Global Impression of Severity (CGIS) score of 4 or higher at screening and baseline
You will not qualify if you...
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening, except nicotine or caffeine use disorder
- History of treatment with clozapine
- History of resistance to schizophrenia medications, defined as no response to 2 or more adequate treatments in the past 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 to 21 days for Part A, 42 days for Part B
Participants receive oral emraclidine or placebo for schizophrenia. Part A involves multiple ascending doses for 14 to 21 days. Part B involves treatment for 42 days.
Multiple visits during treatment as per dosing schedule
Duration - 30 days
Participants are monitored for safety for 30 days after completing treatment.
Approximately 1 follow-up visit
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
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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