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RecruitingPhase 2

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

An Adaptive Two-part Randomized, Double Blind, Placebo-controlled Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Emraclidine in Participants With Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 days, 21 days, 7 days, 30 days
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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 will be followed for 30 days after the last dose of the study drug."
  • "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests emraclidine, a study drug taken by mouth, in adults with schizophrenia. It checks side effects, changes in symptoms, and how the drug moves through the body. Participants receive emraclidine or a placebo, which has no active drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a BMI (a measure of weight compared with height) from 18 to 40 and weigh more than 110 pounds (50 kg).
  • Part A: Have a PANSS score below 80 at screening and the start of the study. PANSS is a scale that measures schizophrenia symptoms.
  • Part B: Have a sudden worsening of symptoms that affect your sense of reality, starting less than 2 months before screening.
  • Part B: Have a PANSS score from 80 to 120 at screening and the start of the study.
  • Part B: Score at least 4 (moderate) on at least 2 required PANSS symptom items at screening and the start of the study. The listing does not name these items.
  • Part B: Have a CGIS score of at least 4 at screening and the start of the study. This rating means you are at least moderately ill.

Who can't join

  • Have had a main mental health diagnosis other than schizophrenia in the 12 months before screening. Nicotine and caffeine use disorders are allowed.
  • Have ever taken clozapine.
  • Have not improved after at least 2 adequate courses of schizophrenia medicine in the past 12 months. Each course must have lasted at least 4 weeks at an adequate dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (7)

AR

CA

MD

NJ

TX