A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia

NCT07145918 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: M25-522
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 7

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 one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. 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

Keywords

Schizophrenia; ABBV-1231

Outcome Measures

Primary Outcomes (23)

• Number of Participants with Adverse Events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

  Up to approximately 74 days

• Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine

  Cmax of Emraclidine

  Up to approximately 24 days

• Part A Only-Time to Cmax (Tmax) of Emraclidine

  Tmax of Emraclidine

  Up to approximately 24 days

• Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine

  AUCt of Emraclidine

  Up to approximately 24 days

• Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine

  AUCtau of Emraclidine

  Up to approximately 24 days

• Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine

  MRCmax of Emraclidine

  Up to approximately 21 days

• Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine

  MRAUCtau of Emraclidine

  Up to approximately 21 days

• Part A Only- Minimum plasma concentration (Cmin) of Emraclidine

  Cmin of Emraclidine

  Up to approximately 21 days

• Part A Only-Average plasma concentration (Cavg) of Emraclidine

  Cavg of Emraclidine

  Up to approximately 21 days

• Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine

  Terminal phase elimination half-life of Emraclidine

  Up to approximately 21 days

• Part A Only-Terminal elimination rate constant (λz) of Emraclidine

  λz of Emraclidine

  Up to approximately 21 days

• Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine

  CL/F of Emraclidine

  Up to approximately 21 days

• Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine

  Vz/F of Emraclidine

  Up to approximately 21 days

• Part A Only-Peak-to-trough ratio (PTR) of Emraclidine

  PTR of Emraclidine

  Up to approximately 21 days

• Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine

  RacCmax of Emraclidine

  Up to approximately 21 days

• Part A Only-Accumulation ratio for AUCta (RacAUCtau) of Emraclidine

  RacAUCta of Emraclidine

  Up to approximately 21 days

• Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)

  Cmax of Metabolite (CV-0000364)

  Up to approximately 24 days

• Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)

  Tmax of Metabolite (CV-000036)

  Up to approximately 24 days

• Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036)

  AUCtau of Metabolite (CV-000036)

  Up to approximately 24 days

• Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)

  AUCt of Metabolite (CV-000036)

  Up to approximately 24 days

• Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036)

  MRCmax of Metabolite (CV-000036)

  Up to approximately 21 days

• Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036)

  MRAUCtau of Metabolite (CV-000036)

  Up to approximately 21 days

• Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score

  PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.

  Up to approximately week 6

Secondary Outcomes (5)

• Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score

  Up to approximately Week 6

• Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score

  Up to approximately 74 days

• Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score

  Up to approximately 53 days

• Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score

  Up to approximately week 6

• Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60)

  Up to approximately week 6

Study Arms (4)

Emraclidine Part A

EXPERIMENTAL

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

Drug: Emraclidine

Placebo-Part A

EXPERIMENTAL

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

Drug: Placebo

Emraclidine-Part B

EXPERIMENTAL

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

Drug: Emraclidine

Placebo-Part B

EXPERIMENTAL

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

Drug: Placebo

Interventions

Emraclidine DRUG

Oral Tablets

Emraclidine Part A; Emraclidine-Part B

Placebo DRUG

Oral Tablets

Placebo-Part A; Placebo-Part B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (7)

Woodland International Research Group /ID# 275747

Little Rock, Arkansas, 72211, United States

RECRUITING

Collaborative Neuroscience Research - Garden Grove /ID# 273005

Garden Grove, California, 92845, United States

RECRUITING

California Clinical Trials Medical Group - Parexel /ID# 275751

Glendale, California, 91206, United States

RECRUITING

Cbh Health - Gaithersburg /ID# 272932

Gaithersburg, Maryland, 20877, United States

RECRUITING

Cenexel Hassman Research Institute (Hri) /ID# 276128

Marlton, New Jersey, 08053, United States

RECRUITING

Community Clinical Research - Austin - Cross Park Drive /ID# 272977

Austin, Texas, 78754, United States

RECRUITING

Pillar Clinical Research - Richardson /ID# 275715

Richardson, Texas, 75080, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 28, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (7)