Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT07145918

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

Led by AbbVie · Updated on 2026-02-10

268

Participants Needed

7

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index (BMI) between 18 and 40 kg/m2 and body weight over 50 kg (110 lbs)
  • For Part A only: PANSS total score less than 80 at screening and baseline
  • For Part B only: experiencing an acute worsening of psychotic symptoms starting less than 2 months before screening
  • For Part B only: PANSS total score between 80 and 120 at screening and baseline
  • For Part B only: score of 4 or higher (moderate or greater) on at least 2 PANSS Positive Scale items at screening and baseline
  • For Part B only: Clinical Global Impression of Severity (CGIS) score of 4 or higher (at least moderately ill) at screening and baseline
Not Eligible

You will not qualify if you...

  • Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (nicotine and caffeine use disorders allowed)
  • History of clozapine treatment
  • History of resistance to schizophrenia medications, defined as not responding to 2 or more adequate treatment courses in the last 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Woodland International Research Group /ID# 275747

Little Rock, Arkansas, United States, 72211

Actively Recruiting

2

Collaborative Neuroscience Research - Garden Grove /ID# 273005

Garden Grove, California, United States, 92845

Actively Recruiting

3

California Clinical Trials Medical Group - Parexel /ID# 275751

Glendale, California, United States, 91206

Actively Recruiting

4

Cbh Health - Gaithersburg /ID# 272932

Gaithersburg, Maryland, United States, 20877

Actively Recruiting

5

Cenexel Hassman Research Institute (Hri) /ID# 276128

Marlton, New Jersey, United States, 08053

Actively Recruiting

6

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

Austin, Texas, United States, 78754

Actively Recruiting

7

Pillar Clinical Research - Richardson /ID# 275715

Richardson, Texas, United States, 75080

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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