A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Other: Placebo; Drug: KarXT

Study type: Interventional

Funder types: Industry

Identifiers

NCT06882785

CN012-0019

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).
• Participants must have a PANSS total score between 80 and 120, inclusive.
• Participants must have a CGI-S score of ≥ 4.

Exclusion Criteria

• Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
• Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.
• Participants must not have any history or presence of clinically significant medical conditions.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

Administration of KarXT

Active Comparator group

Treatment:

Drug: KarXT

Placebo

Placebo Comparator group

Treatment:

Other: Placebo