Recruiting
Phase 2

Emraclidine

Sponsor:

AbbVie

Code:

NCT07145918

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Emraclidine

Placebo

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Study ID

NCT07145918

Start date

Aug 4, 2025

Status verified date

Sep, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

268 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Emraclidine Part A

Participants will be assigned to receive one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period.

experimental: Placebo-Part A

Participants will be assigned to receive one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period.

experimental: Emraclidine-Part B

Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period.

experimental: Placebo-Part B

Participants will receive placebo for 42 days followed by a 30-day safety follow-up period.

Interventions

Emraclidine

Oral Tablets

Placebo

Oral Tablets

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 74 days ]
  • Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine [ Time Frame: Up to approximately 24 days ]
  • Part A Only-Time to Cmax (Tmax) of Emraclidine [ Time Frame: Up to approximately 24 days ]
  • Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine [ Time Frame: Up to approximately 24 days ]
  • Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine [ Time Frame: Up to approximately 24 days ]
  • Part A Only- Minimum plasma concentration (Cmin) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Average plasma concentration (Cavg) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Terminal elimination rate constant (λz) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Peak-to-trough ratio (PTR) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 24 days ]
  • Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036) [ Time Frame: Up to approximately 24 days ]
  • Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 24 days ]
  • Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036) [ Time Frame: Up to approximately 24 days ]
  • Part A Only-Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364) calculated from Cmax [ Time Frame: Up to approximately 21 days ]
  • Part A Only- Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 21 days ]
  • Part A Only- Terminal Phase Elimination Half-Life (t1/2) of of Metabolite (CV-0000364) [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Terminal elimination rate constant (λz) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 21 days ]
  • Part A Only-Peak-to-trough ratio (PTR) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 21 days ]
  • Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Up to approximately week 6 ]
  • Part B Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine [ Time Frame: Up to approximately 24 days ]
  • Part B Only-Time to Cmax (Tmax) of Emraclidine [ Time Frame: Up to approximately 24 days ]
  • Part B Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine [ Time Frame: Up to approximately 24 days ]
  • Part B Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine [ Time Frame: Up to approximately 24 days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Woodland International Research Group /ID# 275747

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Site Coordinator

501-221-8681

California Clinical Trials Medical Group - Parexel /ID# 275751

Recruiting

Glendale, California, United States, 91206

Contacts

Site Coordinator

818-254-1600

CenExel Collaborative Neuroscience Research /ID# 273005

Recruiting

Los Alamitos, California, United States, 90720

Cbh Health - Gaithersburg /ID# 272932

Recruiting

Gaithersburg, Maryland, United States, 20877

Contacts

Site Coordinator

301-251-4702

Cenexel Hassman Research Institute (Hri) /ID# 276128

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Site Coordinator

888-437-4104

Community Clinical Research - Cross Park Drive /ID# 272977

Recruiting

Austin, Texas, United States, 78754

Contacts

Site Coordinator

512-323-2622

Pillar Clinical Research - Richardson /ID# 275715

Recruiting

Richardson, Texas, United States, 75080

Contacts

Site Coordinator

214-396-4844

More Information

Sponsor

AbbVie

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Schizophrenia
  • ABBV-1231

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.