A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
← catalyst calendarNCT07145918 · readout ≤ 559 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
268estimated
Sites
7
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-04 | actual | When the study began enrolling |
| Primary completion | Feb 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Schizophrenia
Interventions
- Drug: Emraclidine
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events (AEs)
measured Up to approximately 74 days
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine
measured Up to approximately 24 days
Part A Only-Time to Cmax (Tmax) of Emraclidine
measured Up to approximately 24 days
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
measured Up to approximately 24 days
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
measured Up to approximately 24 days
Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine
measured Up to approximately 21 days
Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine
measured Up to approximately 21 days
Part A Only- Minimum plasma concentration (Cmin) of Emraclidine
measured Up to approximately 21 days
Part A Only-Average plasma concentration (Cavg) of Emraclidine
measured Up to approximately 21 days
Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
measured Up to approximately 21 days
Part A Only-Terminal elimination rate constant (λz) of Emraclidine
measured Up to approximately 21 days
Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
measured Up to approximately 21 days
Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
measured Up to approximately 21 days
Part A Only-Peak-to-trough ratio (PTR) of Emraclidine
measured Up to approximately 21 days
Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine
measured Up to approximately 21 days
Part A Only-Accumulation ratio for AUCta (RacAUCtau) of Emraclidine
measured Up to approximately 21 days
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
measured Up to approximately 24 days
Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)
measured Up to approximately 24 days
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036)
measured Up to approximately 24 days
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
measured Up to approximately 24 days
Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036)
measured Up to approximately 21 days
Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036)
measured Up to approximately 21 days
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
measured Up to approximately week 6
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