Overview

A Placebo-controlled Trial of 15 and 30 mg QD Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis

Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (15 mg QD and 30 mg QD) in male and female participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cerevel Therapeutics, LLC
Criteria
Inclusion Criteria:

- Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic
Disorders.

- CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline.

- PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at
Baseline.

- Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less
than 60 days prior to signing the ICF.

- Willing to discontinue all prohibited medications to meet protocol-required washouts
prior to and during the trial period.

- Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs).

- Ability, in the opinion of the investigator, to understand the nature of the trial,
participate in trial visits, and comply with protocol requirements.

Exclusion Criteria:

- Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to
schizophrenia are allowed); Acute depressive symptoms within 30 days prior to signing
the ICF that require treatment with an antidepressant are exclusory. Acute manic
symptoms within 30 days prior to signing the ICF that require treatment with a mood
stabilizer are exclusory.

- Any of the following:

- Schizophrenia considered resistant/refractory to antipsychotic treatment by
history (failure to respond to 2 or more courses of adequate pharmacological
treatment defined as an adequate dose per label and a treatment duration of at
least 4 weeks)

- History of response to clozapine treatment only or failure to respond to
clozapine treatment

- Any of the following regarding history of schizophrenia:

- Time from initial onset of schizophrenia <2 years based on prior records or
participant self-report

- Presenting with an initial diagnosis of schizophrenia

- Presenting for the first time with an acute psychotic episode requiring treatment

- Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline.

- Current or past history of significant cardiovascular, pulmonary, gastrointestinal,
renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus),
malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in
situ, at the discretion of the investigator), hematological, immunological,
neurological, or psychiatric disease that, in the opinion of the investigator or
medical monitor, could compromise either participant safety or the results of the
trial.

- Active central nervous system infection, demyelinating disease, degenerative
neurological disease, brain tumor, prior hospitalization for severe head trauma,
seizures (excluding febrile seizures in childhood), or any central nervous system
disease deemed to be progressive during the course of the trial that may confound the
interpretation of the trial results

- Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine
or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF.

- Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale
(C-SSRS) and investigator's clinical assessment.

- Any condition that could possibly affect drug absorption.

- Use of prohibited medications prior to randomization within the required wash-out
period or likely to require prohibited concomitant therapy during the trial.

- Clinically significant abnormal findings on the physical examination, medical history
review, ECG, or clinical laboratory results at screening.

- Positive pregnancy test result prior to receiving IMP. Note: female participants who
are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or
within 7 days after the last dose of IMP are also excluded.