Oral emraclidine for safety, symptom change, and how the body processes it in adults 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
This trial will test whether oral emraclidine is safe, how the body processes it, and whether it can change symptoms in adults with schizophrenia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 268 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 7 sites (Little Rock, Arkansas and 6 other locations) |
| Trial ID | NCT07145918 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial randomizes about 268 adults with schizophrenia to receive oral emraclidine or placebo across two parts: Part A uses multiple ascending doses for 14–21 days and Part B treats participants for up to 42 days. The study collects safety and tolerability data, standardized symptom measures (including PANSS and CGI-S), and pharmacokinetic samples to characterize how the drug moves through the body. Participants are enrolled at roughly 32 sites in the United States and are followed for 30 days after the last dose. Outcomes will compare adverse events, changes in disease activity, and drug exposure between emraclidine and placebo groups.
Who should consider this trial
Good fit: Ideal candidates are adults with schizophrenia who meet study criteria (including BMI 18–40 kg/m2, weight >50 kg, and the specified PANSS and CGI-S scores) and who can attend visits at US study sites.
Not a fit: Patients with a primary DSM-5 disorder other than schizophrenia, prior clozapine exposure, or those outside the specified BMI/weight limits are unlikely to be eligible or receive benefit from this study.
Why it matters
Potential benefit: If successful, emraclidine could offer a new oral treatment option that reduces psychotic symptoms while having an acceptable safety and tolerability profile.
How similar studies have performed: Emraclidine is an investigational compound and, while there is some early-phase work on related mechanisms, there is limited published evidence of clinical efficacy to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 6 other locations
- Woodland International Research Group /ID# 275747 — Little Rock, Arkansas, United States (Recruiting)
- Collaborative Neuroscience Research - Garden Grove /ID# 273005 — Garden Grove, California, United States (Recruiting)
- California Clinical Trials Medical Group - Parexel /ID# 275751 — Glendale, California, United States (Recruiting)
- Cbh Health - Gaithersburg /ID# 272932 — Gaithersburg, Maryland, United States (Recruiting)
- Cenexel Hassman Research Institute (Hri) /ID# 276128 — Marlton, New Jersey, United States (Recruiting)
- Community Clinical Research - Austin - Cross Park Drive /ID# 272977 — Austin, Texas, United States (Recruiting)
- Pillar Clinical Research - Richardson /ID# 275715 — Richardson, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.