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

Conditions

• Schizophrenia

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Emraclidine — DRUG
  Oral Tablets
• Placebo — DRUG
  Oral Tablets

Study Details

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.

Key Dates

Start date

Aug 4, 2025

Status verified

Feb 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

268 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Emraclidine Part A
  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.
• Experimental: Placebo-Part A
  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.
• 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.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 74 days ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (7)

Find similar trials in Little Rock, AR

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