NCT07145918RecruitingPhase 2
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 268 (estimated)
- First submitted
- 22 Aug 2025
- Start date
- 4 Aug 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- AbbVie
- Diseases
- Schizophrenia
- NCT number
- NCT07145918
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 268
- From 4 Aug 2025 to the primary completion date, Feb 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any primary DSM-5 disorder other than schizophrenia (current nicotine use disorder and caffeine use disorder are allowed) within 12 months before Screening.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Community Clinical Research - Cross Park Drive /ID# 272977 Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Cbh Health - Gaithersburg /ID# 272932 Coordinator of this site? Confirm its status | Gaithersburg | United States | Recruiting |
| California Clinical Trials Medical Group - Parexel /ID# 275751 Coordinator of this site? Confirm its status | Glendale | United States | Recruiting |
| Woodland International Research Group /ID# 275747 Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| CenExel Collaborative Neuroscience Research /ID# 273005 Coordinator of this site? Confirm its status | Los Alamitos | United States | Recruiting |
| Cenexel Hassman Research Institute (Hri) /ID# 276128 Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| Pillar Clinical Research - Richardson /ID# 275715 Coordinator of this site? Confirm its status | Richardson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.